Cardiovascular Disease, Diabetes, Obesity
Conditions
Keywords
Low carbohydrate diet, Low fat diet, Glycemic index, Weight loss maintenance
Brief summary
This study will evaluate the effects of dietary composition on energy expenditure and chronic disease risk factors, while also exploring physiological mechanisms underlying these effects.
Detailed description
Many overweight and obese people can lose weight for a few months, but most have difficulty maintaining weight loss over the long term. One explanation for the poor long-term outcome of weight-loss diets relates to behavior, in that motivation to adhere to restrictive regimens typically diminishes with time. An alternative explanation is that weight loss elicits biological adaptations - specifically a decline in energy expenditure and an increase in hunger - that promote weight regain. The purpose of this study is to evaluate the effects of dietary composition on energy expenditure and risk for chronic diseases, while also exploring physiological mechanisms underlying these effects. The study will be performed in collaboration with Framingham State University, providing a novel and feasible method for feeding subjects in dining halls and monitoring compliance. Following 12±2% weight loss on a standard run-in diet, 150 adults (aged 18 to 65 years) will be randomly assigned to one of three weight-loss maintenance diets controlled for protein content (20% of energy) and varying widely in dietary carbohydrate-to-fat ratio: Low-carbohydrate (20% of energy from carbohydrate, 60% fat), Moderate- carbohydrate (40% carbohydrate, 40% fat), High-carbohydrate (60% carbohydrate, 20% fat). During the weight-loss maintenance phase, energy intake will be adjusted to prevent changes in body weight. The primary outcome will be change in total energy expenditure (indirect calorimetry using stable isotopes) through 20 weeks. Secondary outcomes during weight maintenance will include resting energy expenditure (indirect calorimetry using respiratory gas exchange), physical activity (accelerometry), measures of insulin resistance and skeletal muscle work efficiency, components of the metabolic syndrome, and hormonal and metabolic measures that might inform an understanding of physiological mechanisms. We also will assess weight change during a 2-week ad libitum feeding phase, as an objective measure of dietary effects on hunger. The analytic framework for addressing study hypothesis will be repeated-measures analysis of variance, with adjustment for covariates (sex, race, ethnicity, age, anthropometrics, insulin sensitivity and secretion, obesity-related genes). We also will test each covariate for effect modification (covariate × diet interaction).
Interventions
BEHAVIORALFeeding study
Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
Sponsors
Framingham State University
Baylor College of Medicine
Nutrition Science Initiative
New Balance Foundation
Many Voices Foundation
Blue Cross Blue Shield
Boston Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Aged 18 to 65 years * BMI ≥ 25 kg/m2 * Weight ≤ 425 lbs * Medical clearance from a primary care provider * Plans to matriculate at Framingham State University (campus-based participants: students), work on campus (campus-based participants: faculty and staff), or live in the greater Framingham area (community-based participants) throughout the academic year of enrollment in the study * Academic and social clearance from the FSU Office of Enrollment and Student Development (student participants) or willingness to comply with Criminal Offender Record Information (CORI) check and Sex Offender Registry Information (SORI) check (community-based subjects) * Willingness to eat and drink only the foods and beverages on the study menus during participation, with no food allergies or aversions * Willingness to eat in the dining hall * Willingness to abstain from consuming alcohol during participation
Exclusion criteria
* Change in body weight exceeding ±10% during prior year * Recent adherence to a special diet * Recent adherence to a vigorous physical activity regimen (e.g., participation in a varsity sport) * Chronic use of any medication or dietary supplement that could affect study outcomes * Current smoking (1 cigarette in the last week) * Heavy baseline alcohol consumption (\> 10 drinks/week) or history of binge drinking (≥ 5 drinks in 1 day, anytime in past 6 months) * Physician diagnosis of a major medical/psychiatric illness or eating disorder * Abnormal HgA1c, TSH, BUN, creatinine; hematocrit \< 30; ALT \> 200% of normal upper limit * Plans for a vacation during the study that would preclude adherence to prescribed diet * Additional exclusions for female participants: Irregular menstrual cycles; any change in birth control medication during the 3 months prior to enrollment; pregnancy or lactation during the 12 months prior to enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Energy Expenditure, Assessed by Indirect Calorimetry Using Stable Isotopes | Start of Trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | Total energy expenditure (TEE), assessed by indirect calorimetry using stable isotopes Total calories burned: Participants each drank about a cup of water containing special tracers which are measurable when they pass out of the body through urine. They provided a urine sample before they drank the water and then about every other day for the next two (2) weeks. Change: average (midpoint of test phase, end of test phase) - start of trial |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cognitive Function Related to Processing Speed and Executive Function | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | Trail Making Test Parts A and B \[TMT-A, TMT-B\] |
| Change in Self-reported Food Addiction Score | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | Yale Food Addiction Scale \[YFAS\] |
| Change in Self-reported Emotional Eating Score | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | Emotional Eating Scale \[EES\] |
| Change in Self-reported Binge Eating Score | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | Binge Eating Scale \[BES\] |
| Luteinizing Hormone | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | — |
| Follicle Stimulating Hormone | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | — |
| Insulin-like Growth Factor 1 (IGF-1) | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | — |
| IGF Binding Proteins | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | — |
| Testosterone | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | — |
| Resting Energy Expenditure, Assessed by Indirect Calorimetry Using Respiratory Gas Exchange | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | Resting energy expenditure, assessed by indirect calorimetry using respiratory gas exchange Calories burned while resting: Participants lied down with head and neck under a clear plastic bubble, breathing room air. Gases in expired air were collected. Change: average (midpoint of test phase, end of test phase) - start of trial |
| Physical Activity, Assessed by Accelerometry | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | Actigraph Accelerometer Change: average (midpoint of test phase, end of test phase) - start of trial An Actigraph Accelerometer measures movement, similar to a pedometer. Data are reported as counts (divided by 1,000) per day. Each participant wore the the accelerometer on the right hip for 7 days at each time point. |
| Skeletal Muscle Work Efficiency | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | Efficiency is expressed as percentage ratio of power generated during cycle ergometry (with conversion of Watts to kcal/min using a factor of 0.01433) to energy expenditure above resting. Change: end of test phase - start of trial. |
| Leptin (Start of Trial) | Start of trial (time of randomization, post-weight loss) | Leptin levels were log transformed for analysis. For reporting, the adjusted means and 95% Confidence Intervals were retransformed to the original units (exp(mean log)±exp(mean log)×(exp(SE log)-1)). Changes (see Outcome 6) are expressed in percentage units (100%×(exp(change in log)-1)): average (midpoint of test phase, end of test phase) - start of trial |
| Leptin (% Change) | Change through 20 weeks' weight loss maintenance | Leptin levels were log transformed for analysis. Change (expressed in percentage units, 100%×(exp(change in log)-1)): average (midpoint of test phase, end of test phase) - start of trial |
| Ghrelin (Start of Trial) | Start of trial (time of randomization, post-weight loss) | Ghrelin levels were log transformed for analysis. For reporting, the adjusted means and 95% Confidence Intervals were retransformed to the original units (exp(mean log)±exp(mean log)×(exp(SE log)-1)). Changes (see Outcome 8) are expressed in percentage units (100%×(exp(change in log)-1)): average (midpoint of test phase, end of test phase) - start of trial |
| Ghrelin (% Change) | Change through 20 weeks' weight loss maintenance | Ghrelin levels were log transformed for analysis. Change (expressed in percentage units, 100%×(exp(change in log)-1)): average (midpoint of test phase, end of test phase) - start of trial |
| 1,5-Anhydroglucitol | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | Biomeasure of carbohydrate intake Change, 10 weeks: midpoint of test phase - start of trial Change, 20 weeks: end of test phase - start of trial |
| Glycemic Control, Assessed by HgA1c | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | Change, 10 weeks: midpoint of test phase - start of trial. Change, 20 weeks: end of test phase - start of trial. |
| Triglycerides | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | Triglyceride levels were log transformed for analysis. For reporting, the adjusted means and 95% Confidence Intervals were retransformed to the original units Change, 10 weeks: midpoint of test phase - start of trial Change, 20 weeks: end of test phase - start of trial |
| Body Composition (DXA) | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | Body fat, presented as a % of total mass Participants each had a special scan (x-ray) to measure their amount of body fat. The special x-ray is called dual-energy x-ray absorptiometry (DXA). They were asked to lie still on a table for x-ray pictures. Change: end of test phase - start of trial |
| Glucose | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | Glucose level, fasting blood draw Change: end of test phase - start of trial |
| Change in Lipoprotein Particle Subfraction Distribution | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | Lipoprotein insulin resistance (LPIR) score was calculated from triglyceride-rich, high-density, and low-density lipoprotein particle (TRL-P, HDL-P, LDL-P) sizes and subfraction concentrations (large/very large TRL-P, large HDL-P, small LDL-P). LPIR score is quantified on a scale of 0-100. Higher scores indicate worse outcome. Change: end of test phase - start of trial |
| Total Cholesterol | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | Change: end of test phase - start of trial |
| HDL-Cholesterol | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | High-density lipoprotein cholesterol Change, 10 weeks: midpoint of test phase - start of trial. Change, 20 weeks: end of test phase - start of trial. |
| Non-HDL-Cholesterol | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | Calculated by subtracting HDL-cholesterol from total cholesterol. Change: end of test phase - start of trial |
| LDL-Cholesterol | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | Low-density-lipoprotein cholesterol Change: end of test phase - start of trial |
| Adiponectin (Start of Trial) | Start of trial (time of randomization, post-weight loss) | Total and high molecular weight adiponectin Adiponectin levels were log transformed for analysis. For reporting, the adjusted means and 95% Confidence Intervals were retransformed to the original units (exp(mean log)±exp(mean log)×(exp(SE log)-1)). Changes (see Outcome 20) are expressed in percentage units (100%×(exp(change in log)-1)): end of test phase - start of trial |
| Adiponectin (% Change) | Change through 20 weeks' weight loss maintenance | Adiponeptin levels were log transformed for analysis. Change (expressed in percentage units, 100%×(exp(change in log)-1)): end of test phase - start of trial |
| C-reactive Protein (Start of Trial) | Start of trial (time of randomization, post-weight loss) | C-reactive protein, marker of inflammation C-reactive protein levels were log transformed for analysis. For reporting, the adjusted means and 95% Confidence Intervals were retransformed to the original units (exp(mean log)±exp(mean log)×(exp(SE log)-1)). Changes (see Outcome 22) are expressed in percentage units (100%×(exp(change in log)-1)): end of test phase - start of trial |
| C-reactive Protein (% Change) | Change through 20 weeks' weight loss maintenance | C-reactive protein, marker of inflammation C-reactive protein levels were log transformed for analysis. Change (expressed in percentage units, 100%×(exp(change in log)-1)): end of test phase - start of trial |
| IL-6 (Start of Trial) | Start of trial (time of randomization, post-weight loss) | Interleukin-6, marker of inflammation Interleukin-6 levels were log transformed for analysis. For reporting, the adjusted means and 95% Confidence Intervals were retransformed to the original units (exp(mean log)±exp(mean log)×(exp(SE log)-1)). Changes (see Outcome 24) are expressed in percentage units (100%×(exp(change in log)-1)): end of test phase - start of trial |
| IL-6 (% Change) | Change through 20 weeks' weight loss maintenance | Interleukin-6, marker of inflammation Interleukin-6 levels were log transformed for analysis. Change (expressed in percentage units, 100%×(exp(change in log)-1)): end of test phase - start of trial |
| Blood Pressure | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | Systolic and diastolic blood pressure Change: end of test phase - start of trial |
| Plasminogen Activator Inhibitor-1 (Start of Trial) | Start of trial (time of randomization, post-weight loss) | Plasminogen activator inhibitor-1 levels were log transformed for analysis. For reporting, the adjusted means and 95% Confidence Intervals were retransformed to the original units (exp(mean log)±exp(mean log)×(exp(SE log)-1)). Changes (see Outcome 27) are expressed in percentage units (100%×(exp(change in log)-1)): end of test phase - start of trial |
| Plasminogen Activator Inhibitor-1 (% Change) | Change through 20 weeks' weight loss maintenance | Plasminogen activator inhibitor-1 levels were log transformed for analysis. Change (expressed in percentage units, 100%×(exp(change in log)-1)): end of test phase - start of trial |
| Fibrinogen | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | Change: end of test phase - start of trial |
| Insulin Secretion Determined as Blood Insulin Concentration 30 Minutes After Oral Glucose (Start of Trial) | Start of trial (time of randomization, post-weight loss) | Insulin level 30 minutes after consuming 75 grams of glucose |
| Thyroxine (T4) | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | thyroid function test |
| Free T4 | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | free thyroxine, thyroid function test |
| Thyroid Stimulating Hormone | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | Produced by the pituitary gland in the brain. Tells the thyroid gland to make thyroid hormones. |
| Reverse T3 | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | thyroid function test, inactive form of triiodothyronine (T3) Lifespan Bio kit was used for analysis. The range of this kit is 250 to 5000 pg/mL, which varies from other commercially available kits (about 10-fold greater values). |
| Urinary Cortisol Excretion | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | cortisol (stress hormone) excreted in the urine over a 24-hour period |
| Urinary Catecholamine - Adrenaline | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | catecholamine excreted in the urine over 24 hours, also known as epinephrine |
| Urinary Catecholamine - Dopamine | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | catecholamine excreted in the urine over 24 hours |
| Urinary Catecholamine - Noradrenaline | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | catecholamine excreted in the urine over 24 hours, also known as norepinephrine |
| Insulin Sensitivity (Hepatic), Assessed by Frequently-sampled Oral Glucose Tolerance Test | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | — |
| Insulin Sensitivity (Systemic), Assessed by Frequently-sampled Oral Glucose Tolerance Test | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | — |
| Non-esterified Fatty Acids | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | — |
| Serum Ketones/Ketoacids | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | — |
| Lactate | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | — |
| Metabolic Fuel Concentration in Serum (Glucose, Nonesterified Fatty Acids, Ketones/Ketoacids, Lactate) | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | — |
| Body Weight Change During ad Libitum Feeding | Ad libitum feeding period (weeks 21 and 22 following randomization) | — |
| Gut Microbiome Profile | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | — |
| Serum Metabolomics Profile | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | — |
| Change in Cognitive Function Related to Memory | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | California Verbal Learning Test - Second Edition \[CVLT-II\] and Digit Span Test |
| Estradiol | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | — |
| Change in Self-reported Sleep Quality | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | — |
| Change in Self-reported Depression Measure | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | Beck Depression Inventory-II \[BDI-II\] |
| Change in Self-reported Mood/Anxiety | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | Mood and Anxiety Symptom Questionnaire \[MASQ\] |
Other
| Measure | Time frame | Description |
|---|---|---|
| Effect Modification by Insulin Resistance of Metabolic Responses to Diet | Start of (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | — |
| Effect Modification by Amylase Gene Copy Number | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | — |
| Effect Modification by Insulin Secretion of Metabolic Responses to Diet | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | Effect modifier: Insulin level 30 minutes into an standard OGTT (Insulin-30) Outcome: Total Energy Expenditure Tertiles: Pre-weight-loss Insulin-30 (Low, Moderate, High) Change: average (midpoint of test phase, end of test phase) - start of trial |
Countries
United States
Participant flow
Recruitment details
We recruited participants by posting flyers, newspaper advertisements, and Internet announcements.
Pre-assignment details
We enrolled 234 participants for the run-in phase. Of these, 164 participants achieved at least 10% weight loss and were randomly assigned to one of three diets for the test phase (low-carbohydrate diet, n=57; moderate-carbohydrate diet, n=53; or high-carbohydrate diet, n=54).
Participants by arm
| Arm | Count |
|---|---|
| Low Carbohydrate Diet Feeding study. Composition (by proportion of calories): 20% carbohydrate, 60% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum | 57 |
| Moderate Carbohydrate Diet Feeding study. Composition (by proportion of calories): 40% carbohydrate, 40% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum | 53 |
| High Carbohydrate Diet Feeding study. Composition (by proportion of calories): 60% carbohydrate, 20% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum | 54 |
| Total | 164 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrew | 3 | 5 | 8 |
Baseline characteristics
| Characteristic | Low Carbohydrate Diet | Moderate Carbohydrate Diet | High Carbohydrate Diet | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 57 Participants | 53 Participants | 54 Participants | 164 Participants |
| Age, Continuous | 37.1 years STANDARD_DEVIATION 13.3 | 37.3 years STANDARD_DEVIATION 14.9 | 39.8 years STANDARD_DEVIATION 15.1 | 37.8 years STANDARD_DEVIATION 14.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants | 7 Participants | 8 Participants | 25 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 47 Participants | 46 Participants | 46 Participants | 139 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 57 participants | 53 participants | 54 participants | 164 participants |
| Sex: Female, Male Female | 37 Participants | 36 Participants | 42 Participants | 115 Participants |
| Sex: Female, Male Male | 20 Participants | 17 Participants | 12 Participants | 49 Participants |
| Total Energy Expenditure | 3110 kcal/d STANDARD_DEVIATION 680 | 3030 kcal/d STANDARD_DEVIATION 788 | 2915 kcal/d STANDARD_DEVIATION 686 | 3021 kcal/d STANDARD_DEVIATION 719 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 234 | 0 / 57 | 0 / 53 | 0 / 54 |
| other Total, other adverse events | 28 / 234 | 5 / 57 | 6 / 53 | 1 / 54 |
| serious Total, serious adverse events | 0 / 234 | 0 / 57 | 0 / 53 | 2 / 54 |
Outcome results
Primary
Total Energy Expenditure, Assessed by Indirect Calorimetry Using Stable Isotopes
Total energy expenditure (TEE), assessed by indirect calorimetry using stable isotopes Total calories burned: Participants each drank about a cup of water containing special tracers which are measurable when they pass out of the body through urine. They provided a urine sample before they drank the water and then about every other day for the next two (2) weeks. Change: average (midpoint of test phase, end of test phase) - start of trial
Time frame: Start of Trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Population: Intention-to-treat analysis
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Low Carbohydrate Diet | Total Energy Expenditure, Assessed by Indirect Calorimetry Using Stable Isotopes | Start of Trial | 2713 kcal/d |
| Low Carbohydrate Diet | Total Energy Expenditure, Assessed by Indirect Calorimetry Using Stable Isotopes | Change | 190 kcal/d |
| Moderate Carbohydrate Diet | Total Energy Expenditure, Assessed by Indirect Calorimetry Using Stable Isotopes | Start of Trial | 2504 kcal/d |
| Moderate Carbohydrate Diet | Total Energy Expenditure, Assessed by Indirect Calorimetry Using Stable Isotopes | Change | 71 kcal/d |
| High Carbohydrate Diet | Total Energy Expenditure, Assessed by Indirect Calorimetry Using Stable Isotopes | Start of Trial | 2640 kcal/d |
| High Carbohydrate Diet | Total Energy Expenditure, Assessed by Indirect Calorimetry Using Stable Isotopes | Change | -19 kcal/d |
Secondary
1,5-Anhydroglucitol
Biomeasure of carbohydrate intake Change, 10 weeks: midpoint of test phase - start of trial Change, 20 weeks: end of test phase - start of trial
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Low Carbohydrate Diet | 1,5-Anhydroglucitol | Start of Trial | 16.7 ug/mL |
| Low Carbohydrate Diet | 1,5-Anhydroglucitol | Change, 20 weeks | -3.5 ug/mL |
| Low Carbohydrate Diet | 1,5-Anhydroglucitol | Change, 10 weeks | -2.5 ug/mL |
| Moderate Carbohydrate Diet | 1,5-Anhydroglucitol | Change, 20 weeks | -1.8 ug/mL |
| Moderate Carbohydrate Diet | 1,5-Anhydroglucitol | Change, 10 weeks | -1.2 ug/mL |
| Moderate Carbohydrate Diet | 1,5-Anhydroglucitol | Start of Trial | 17.2 ug/mL |
| High Carbohydrate Diet | 1,5-Anhydroglucitol | Change, 20 weeks | 0.6 ug/mL |
| High Carbohydrate Diet | 1,5-Anhydroglucitol | Start of Trial | 17.1 ug/mL |
| High Carbohydrate Diet | 1,5-Anhydroglucitol | Change, 10 weeks | 0.1 ug/mL |
Secondary
Adiponectin (% Change)
Adiponeptin levels were log transformed for analysis. Change (expressed in percentage units, 100%×(exp(change in log)-1)): end of test phase - start of trial
Time frame: Change through 20 weeks' weight loss maintenance
Population: Retention rate was 90%, with 148 of 164 participants completing the study and 147 included in the analysis (after a priori exclusion of one participant who developed hypothyroidism).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Low Carbohydrate Diet | Adiponectin (% Change) | Total | 33.6 % change |
| Low Carbohydrate Diet | Adiponectin (% Change) | High Molecular Weight | 42.9 % change |
| Moderate Carbohydrate Diet | Adiponectin (% Change) | Total | 17.4 % change |
| Moderate Carbohydrate Diet | Adiponectin (% Change) | High Molecular Weight | 27.6 % change |
| High Carbohydrate Diet | Adiponectin (% Change) | High Molecular Weight | 27.8 % change |
| High Carbohydrate Diet | Adiponectin (% Change) | Total | 23.0 % change |
Secondary
Adiponectin (Start of Trial)
Total and high molecular weight adiponectin Adiponectin levels were log transformed for analysis. For reporting, the adjusted means and 95% Confidence Intervals were retransformed to the original units (exp(mean log)±exp(mean log)×(exp(SE log)-1)). Changes (see Outcome 20) are expressed in percentage units (100%×(exp(change in log)-1)): end of test phase - start of trial
Time frame: Start of trial (time of randomization, post-weight loss)
Population: Retention rate was 90%, with 148 of 164 participants completing the study and 147 included in the analysis (after a priori exclusion of one participant who developed hypothyroidism).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Low Carbohydrate Diet | Adiponectin (Start of Trial) | Total | 4.0 ng/mL |
| Low Carbohydrate Diet | Adiponectin (Start of Trial) | High Molecular Weight | 2.3 ng/mL |
| Moderate Carbohydrate Diet | Adiponectin (Start of Trial) | Total | 5.1 ng/mL |
| Moderate Carbohydrate Diet | Adiponectin (Start of Trial) | High Molecular Weight | 2.8 ng/mL |
| High Carbohydrate Diet | Adiponectin (Start of Trial) | Total | 4.9 ng/mL |
| High Carbohydrate Diet | Adiponectin (Start of Trial) | High Molecular Weight | 2.7 ng/mL |
Secondary
Blood Pressure
Systolic and diastolic blood pressure Change: end of test phase - start of trial
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Population: Retention rate was 90%, with 148 of 164 participants completing the study and 147 included in the analysis (after a priori exclusion of one participant who developed hypothyroidism).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Low Carbohydrate Diet | Blood Pressure | Diastolic, Change | 2.2 mmHg |
| Low Carbohydrate Diet | Blood Pressure | Diastolic, Start of trial | 70.7 mmHg |
| Low Carbohydrate Diet | Blood Pressure | Systolic, Change | -1.5 mmHg |
| Low Carbohydrate Diet | Blood Pressure | Systolic, Start of trial | 117.2 mmHg |
| Moderate Carbohydrate Diet | Blood Pressure | Diastolic, Start of trial | 73.7 mmHg |
| Moderate Carbohydrate Diet | Blood Pressure | Systolic, Change | 0.0 mmHg |
| Moderate Carbohydrate Diet | Blood Pressure | Systolic, Start of trial | 119.2 mmHg |
| Moderate Carbohydrate Diet | Blood Pressure | Diastolic, Change | 1.4 mmHg |
| High Carbohydrate Diet | Blood Pressure | Systolic, Change | 1.8 mmHg |
| High Carbohydrate Diet | Blood Pressure | Systolic, Start of trial | 114.3 mmHg |
| High Carbohydrate Diet | Blood Pressure | Diastolic, Change | 2.2 mmHg |
| High Carbohydrate Diet | Blood Pressure | Diastolic, Start of trial | 70.5 mmHg |
Secondary
Body Composition (DXA)
Body fat, presented as a % of total mass Participants each had a special scan (x-ray) to measure their amount of body fat. The special x-ray is called dual-energy x-ray absorptiometry (DXA). They were asked to lie still on a table for x-ray pictures. Change: end of test phase - start of trial
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Population: Intention-to-treat analysis
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Low Carbohydrate Diet | Body Composition (DXA) | Start of Trial | 36.2 % of total body mass |
| Low Carbohydrate Diet | Body Composition (DXA) | Change | -0.3 % of total body mass |
| Moderate Carbohydrate Diet | Body Composition (DXA) | Start of Trial | 37.3 % of total body mass |
| Moderate Carbohydrate Diet | Body Composition (DXA) | Change | -0.3 % of total body mass |
| High Carbohydrate Diet | Body Composition (DXA) | Start of Trial | 37.8 % of total body mass |
| High Carbohydrate Diet | Body Composition (DXA) | Change | -0.5 % of total body mass |
Secondary
Body Weight Change During ad Libitum Feeding
Time frame: Ad libitum feeding period (weeks 21 and 22 following randomization)
Secondary
Change in Cognitive Function Related to Memory
California Verbal Learning Test - Second Edition \[CVLT-II\] and Digit Span Test
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Secondary
Change in Cognitive Function Related to Processing Speed and Executive Function
Trail Making Test Parts A and B \[TMT-A, TMT-B\]
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Secondary
Change in Lipoprotein Particle Subfraction Distribution
Lipoprotein insulin resistance (LPIR) score was calculated from triglyceride-rich, high-density, and low-density lipoprotein particle (TRL-P, HDL-P, LDL-P) sizes and subfraction concentrations (large/very large TRL-P, large HDL-P, small LDL-P). LPIR score is quantified on a scale of 0-100. Higher scores indicate worse outcome. Change: end of test phase - start of trial
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Population: Retention rate was 90%, with 148 of 164 participants completing the study and 147 included in the analysis (after a priori exclusion of one participant who developed hypothyroidism).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Low Carbohydrate Diet | Change in Lipoprotein Particle Subfraction Distribution | Change | -5.3 score on a scale (0-100) |
| Low Carbohydrate Diet | Change in Lipoprotein Particle Subfraction Distribution | Start of trial | 34.6 score on a scale (0-100) |
| Moderate Carbohydrate Diet | Change in Lipoprotein Particle Subfraction Distribution | Start of trial | 31.5 score on a scale (0-100) |
| Moderate Carbohydrate Diet | Change in Lipoprotein Particle Subfraction Distribution | Change | -0.02 score on a scale (0-100) |
| High Carbohydrate Diet | Change in Lipoprotein Particle Subfraction Distribution | Start of trial | 31.4 score on a scale (0-100) |
| High Carbohydrate Diet | Change in Lipoprotein Particle Subfraction Distribution | Change | 3.6 score on a scale (0-100) |
Secondary
Change in Self-reported Binge Eating Score
Binge Eating Scale \[BES\]
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Secondary
Change in Self-reported Depression Measure
Beck Depression Inventory-II \[BDI-II\]
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Secondary
Change in Self-reported Emotional Eating Score
Emotional Eating Scale \[EES\]
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Secondary
Change in Self-reported Food Addiction Score
Yale Food Addiction Scale \[YFAS\]
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Secondary
Change in Self-reported Mood/Anxiety
Mood and Anxiety Symptom Questionnaire \[MASQ\]
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Secondary
Change in Self-reported Sleep Quality
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Secondary
C-reactive Protein (% Change)
C-reactive protein, marker of inflammation C-reactive protein levels were log transformed for analysis. Change (expressed in percentage units, 100%×(exp(change in log)-1)): end of test phase - start of trial
Time frame: Change through 20 weeks' weight loss maintenance
Population: Retention rate was 90%, with 148 of 164 participants completing the study and 147 included in the analysis (after a priori exclusion of one participant who developed hypothyroidism).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Low Carbohydrate Diet | C-reactive Protein (% Change) | -9.9 % change |
| Moderate Carbohydrate Diet | C-reactive Protein (% Change) | -20.6 % change |
| High Carbohydrate Diet | C-reactive Protein (% Change) | -1.7 % change |
Secondary
C-reactive Protein (Start of Trial)
C-reactive protein, marker of inflammation C-reactive protein levels were log transformed for analysis. For reporting, the adjusted means and 95% Confidence Intervals were retransformed to the original units (exp(mean log)±exp(mean log)×(exp(SE log)-1)). Changes (see Outcome 22) are expressed in percentage units (100%×(exp(change in log)-1)): end of test phase - start of trial
Time frame: Start of trial (time of randomization, post-weight loss)
Population: Retention rate was 90%, with 148 of 164 participants completing the study and 147 included in the analysis (after a priori exclusion of one participant who developed hypothyroidism).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Low Carbohydrate Diet | C-reactive Protein (Start of Trial) | 1.1 mg/L |
| Moderate Carbohydrate Diet | C-reactive Protein (Start of Trial) | 1.5 mg/L |
| High Carbohydrate Diet | C-reactive Protein (Start of Trial) | 1.5 mg/L |
Secondary
Estradiol
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Secondary
Fibrinogen
Change: end of test phase - start of trial
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Population: Retention rate was 90%, with 148 of 164 participants completing the study and 147 included in the analysis (after a priori exclusion of one participant who developed hypothyroidism).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Low Carbohydrate Diet | Fibrinogen | Start of trial | 421.1 mg/dL |
| Low Carbohydrate Diet | Fibrinogen | Change | -17.0 mg/dL |
| Moderate Carbohydrate Diet | Fibrinogen | Start of trial | 461.0 mg/dL |
| Moderate Carbohydrate Diet | Fibrinogen | Change | -22.4 mg/dL |
| High Carbohydrate Diet | Fibrinogen | Start of trial | 428.1 mg/dL |
| High Carbohydrate Diet | Fibrinogen | Change | -21.7 mg/dL |
Secondary
Follicle Stimulating Hormone
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Secondary
Free T4
free thyroxine, thyroid function test
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Population: Descriptive data, reflecting participant flow End of test phase (N=148, completers)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Low Carbohydrate Diet | Free T4 | Start of trial | 14.9 pmol/L |
| Low Carbohydrate Diet | Free T4 | Pre-weight loss | 14.3 pmol/L |
| Low Carbohydrate Diet | Free T4 | End of test phase | 15.4 pmol/L |
| Moderate Carbohydrate Diet | Free T4 | Start of trial | 15.2 pmol/L |
| Moderate Carbohydrate Diet | Free T4 | Pre-weight loss | 15.0 pmol/L |
| Moderate Carbohydrate Diet | Free T4 | End of test phase | 15.7 pmol/L |
| High Carbohydrate Diet | Free T4 | Pre-weight loss | 14.8 pmol/L |
| High Carbohydrate Diet | Free T4 | End of test phase | 15.2 pmol/L |
| High Carbohydrate Diet | Free T4 | Start of trial | 15.0 pmol/L |
Secondary
Ghrelin (% Change)
Ghrelin levels were log transformed for analysis. Change (expressed in percentage units, 100%×(exp(change in log)-1)): average (midpoint of test phase, end of test phase) - start of trial
Time frame: Change through 20 weeks' weight loss maintenance
Population: Intention-to-treat analysis
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Low Carbohydrate Diet | Ghrelin (% Change) | -11.8 % change |
| Moderate Carbohydrate Diet | Ghrelin (% Change) | -8.7 % change |
| High Carbohydrate Diet | Ghrelin (% Change) | -4.9 % change |
Secondary
Ghrelin (Start of Trial)
Ghrelin levels were log transformed for analysis. For reporting, the adjusted means and 95% Confidence Intervals were retransformed to the original units (exp(mean log)±exp(mean log)×(exp(SE log)-1)). Changes (see Outcome 8) are expressed in percentage units (100%×(exp(change in log)-1)): average (midpoint of test phase, end of test phase) - start of trial
Time frame: Start of trial (time of randomization, post-weight loss)
Population: Intention-to-treat analysis
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Low Carbohydrate Diet | Ghrelin (Start of Trial) | 598.2 pg/mL |
| Moderate Carbohydrate Diet | Ghrelin (Start of Trial) | 640.1 pg/mL |
| High Carbohydrate Diet | Ghrelin (Start of Trial) | 693.2 pg/mL |
Secondary
Glucose
Glucose level, fasting blood draw Change: end of test phase - start of trial
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Population: Intention-to-treat analysis
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Low Carbohydrate Diet | Glucose | Start of Trial | 95.1 mg/dL |
| Low Carbohydrate Diet | Glucose | Change | 1.0 mg/dL |
| Moderate Carbohydrate Diet | Glucose | Start of Trial | 94.3 mg/dL |
| Moderate Carbohydrate Diet | Glucose | Change | -0.3 mg/dL |
| High Carbohydrate Diet | Glucose | Start of Trial | 95.1 mg/dL |
| High Carbohydrate Diet | Glucose | Change | -1.0 mg/dL |
Secondary
Glycemic Control, Assessed by HgA1c
Change, 10 weeks: midpoint of test phase - start of trial. Change, 20 weeks: end of test phase - start of trial.
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Low Carbohydrate Diet | Glycemic Control, Assessed by HgA1c | Start of Trial | 5.56 % hemoglobin with glucose bound |
| Low Carbohydrate Diet | Glycemic Control, Assessed by HgA1c | Change, 10 weeks | 0.01 % hemoglobin with glucose bound |
| Low Carbohydrate Diet | Glycemic Control, Assessed by HgA1c | Change, 20 weeks | -0.01 % hemoglobin with glucose bound |
| Moderate Carbohydrate Diet | Glycemic Control, Assessed by HgA1c | Change, 20 weeks | 0.00 % hemoglobin with glucose bound |
| Moderate Carbohydrate Diet | Glycemic Control, Assessed by HgA1c | Change, 10 weeks | 0.03 % hemoglobin with glucose bound |
| Moderate Carbohydrate Diet | Glycemic Control, Assessed by HgA1c | Start of Trial | 5.58 % hemoglobin with glucose bound |
| High Carbohydrate Diet | Glycemic Control, Assessed by HgA1c | Change, 10 weeks | -0.01 % hemoglobin with glucose bound |
| High Carbohydrate Diet | Glycemic Control, Assessed by HgA1c | Change, 20 weeks | -0.05 % hemoglobin with glucose bound |
| High Carbohydrate Diet | Glycemic Control, Assessed by HgA1c | Start of Trial | 5.61 % hemoglobin with glucose bound |
Secondary
Gut Microbiome Profile
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Secondary
HDL-Cholesterol
High-density lipoprotein cholesterol Change, 10 weeks: midpoint of test phase - start of trial. Change, 20 weeks: end of test phase - start of trial.
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Low Carbohydrate Diet | HDL-Cholesterol | Change, 10 weeks | 11.1 md/dL |
| Low Carbohydrate Diet | HDL-Cholesterol | Start of Trial | 47.8 md/dL |
| Low Carbohydrate Diet | HDL-Cholesterol | Change, 20 weeks | 13.0 md/dL |
| Moderate Carbohydrate Diet | HDL-Cholesterol | Change, 20 weeks | 9.7 md/dL |
| Moderate Carbohydrate Diet | HDL-Cholesterol | Start of Trial | 49.1 md/dL |
| Moderate Carbohydrate Diet | HDL-Cholesterol | Change, 10 weeks | 6.9 md/dL |
| High Carbohydrate Diet | HDL-Cholesterol | Change, 20 weeks | 6.8 md/dL |
| High Carbohydrate Diet | HDL-Cholesterol | Change, 10 weeks | 4.7 md/dL |
| High Carbohydrate Diet | HDL-Cholesterol | Start of Trial | 47.6 md/dL |
Secondary
IGF Binding Proteins
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Secondary
IL-6 (% Change)
Interleukin-6, marker of inflammation Interleukin-6 levels were log transformed for analysis. Change (expressed in percentage units, 100%×(exp(change in log)-1)): end of test phase - start of trial
Time frame: Change through 20 weeks' weight loss maintenance
Population: Retention rate was 90%, with 148 of 164 participants completing the study and 147 included in the analysis (after a priori exclusion of one participant who developed hypothyroidism).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Low Carbohydrate Diet | IL-6 (% Change) | -23.6 % change |
| Moderate Carbohydrate Diet | IL-6 (% Change) | -20.1 % change |
| High Carbohydrate Diet | IL-6 (% Change) | -18.3 % change |
Secondary
IL-6 (Start of Trial)
Interleukin-6, marker of inflammation Interleukin-6 levels were log transformed for analysis. For reporting, the adjusted means and 95% Confidence Intervals were retransformed to the original units (exp(mean log)±exp(mean log)×(exp(SE log)-1)). Changes (see Outcome 24) are expressed in percentage units (100%×(exp(change in log)-1)): end of test phase - start of trial
Time frame: Start of trial (time of randomization, post-weight loss)
Population: Retention rate was 90%, with 148 of 164 participants completing the study and 147 included in the analysis (after a priori exclusion of one participant who developed hypothyroidism).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Low Carbohydrate Diet | IL-6 (Start of Trial) | 1.4 pg/mL |
| Moderate Carbohydrate Diet | IL-6 (Start of Trial) | 1.8 pg/mL |
| High Carbohydrate Diet | IL-6 (Start of Trial) | 1.7 pg/mL |
Secondary
Insulin-like Growth Factor 1 (IGF-1)
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Secondary
Insulin Secretion Determined as Blood Insulin Concentration 30 Minutes After Oral Glucose (Start of Trial)
Insulin level 30 minutes after consuming 75 grams of glucose
Time frame: Start of trial (time of randomization, post-weight loss)
Population: Descriptive data, reflecting participant flow Pre-weight loss (N=162, minus 1 participant in the Moderate carbohydrate diet group for whom insulin-30 result is missing) Start of trial (N=162) End of test phase (N=148, minus 1 participant in the High carbohydrate diet group for whom insulin-30 result is missing)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Low Carbohydrate Diet | Insulin Secretion Determined as Blood Insulin Concentration 30 Minutes After Oral Glucose (Start of Trial) | Start of trial | 95.9 mIU/L |
| Low Carbohydrate Diet | Insulin Secretion Determined as Blood Insulin Concentration 30 Minutes After Oral Glucose (Start of Trial) | Pre-weight loss | 131.4 mIU/L |
| Low Carbohydrate Diet | Insulin Secretion Determined as Blood Insulin Concentration 30 Minutes After Oral Glucose (Start of Trial) | End of test phase | 96.2 mIU/L |
| Moderate Carbohydrate Diet | Insulin Secretion Determined as Blood Insulin Concentration 30 Minutes After Oral Glucose (Start of Trial) | Start of trial | 79.9 mIU/L |
| Moderate Carbohydrate Diet | Insulin Secretion Determined as Blood Insulin Concentration 30 Minutes After Oral Glucose (Start of Trial) | Pre-weight loss | 116.7 mIU/L |
| Moderate Carbohydrate Diet | Insulin Secretion Determined as Blood Insulin Concentration 30 Minutes After Oral Glucose (Start of Trial) | End of test phase | 74.5 mIU/L |
| High Carbohydrate Diet | Insulin Secretion Determined as Blood Insulin Concentration 30 Minutes After Oral Glucose (Start of Trial) | Pre-weight loss | 99.2 mIU/L |
| High Carbohydrate Diet | Insulin Secretion Determined as Blood Insulin Concentration 30 Minutes After Oral Glucose (Start of Trial) | End of test phase | 74.8 mIU/L |
| High Carbohydrate Diet | Insulin Secretion Determined as Blood Insulin Concentration 30 Minutes After Oral Glucose (Start of Trial) | Start of trial | 68.0 mIU/L |
Secondary
Insulin Sensitivity (Hepatic), Assessed by Frequently-sampled Oral Glucose Tolerance Test
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Secondary
Insulin Sensitivity (Systemic), Assessed by Frequently-sampled Oral Glucose Tolerance Test
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Secondary
Lactate
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Secondary
LDL-Cholesterol
Low-density-lipoprotein cholesterol Change: end of test phase - start of trial
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Population: Retention rate was 90%, with 148 of 164 participants completing the study and 147 included in the analysis (after a priori exclusion of one participant who developed hypothyroidism).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Low Carbohydrate Diet | LDL-Cholesterol | Start of trial | 80.6 mg/dL |
| Low Carbohydrate Diet | LDL-Cholesterol | Change | 10.0 mg/dL |
| Moderate Carbohydrate Diet | LDL-Cholesterol | Start of trial | 77.6 mg/dL |
| Moderate Carbohydrate Diet | LDL-Cholesterol | Change | 11.7 mg/dL |
| High Carbohydrate Diet | LDL-Cholesterol | Start of trial | 79.5 mg/dL |
| High Carbohydrate Diet | LDL-Cholesterol | Change | 8.2 mg/dL |
Secondary
Leptin (% Change)
Leptin levels were log transformed for analysis. Change (expressed in percentage units, 100%×(exp(change in log)-1)): average (midpoint of test phase, end of test phase) - start of trial
Time frame: Change through 20 weeks' weight loss maintenance
Population: Intention-to-treat analysis
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Low Carbohydrate Diet | Leptin (% Change) | 17.9 % change |
| Moderate Carbohydrate Diet | Leptin (% Change) | 34.8 % change |
| High Carbohydrate Diet | Leptin (% Change) | 34.2 % change |
Secondary
Leptin (Start of Trial)
Leptin levels were log transformed for analysis. For reporting, the adjusted means and 95% Confidence Intervals were retransformed to the original units (exp(mean log)±exp(mean log)×(exp(SE log)-1)). Changes (see Outcome 6) are expressed in percentage units (100%×(exp(change in log)-1)): average (midpoint of test phase, end of test phase) - start of trial
Time frame: Start of trial (time of randomization, post-weight loss)
Population: Intention-to-treat analysis
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Low Carbohydrate Diet | Leptin (Start of Trial) | 9.6 ng/mL |
| Moderate Carbohydrate Diet | Leptin (Start of Trial) | 9.8 ng/mL |
| High Carbohydrate Diet | Leptin (Start of Trial) | 10.9 ng/mL |
Secondary
Luteinizing Hormone
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Secondary
Metabolic Fuel Concentration in Serum (Glucose, Nonesterified Fatty Acids, Ketones/Ketoacids, Lactate)
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Secondary
Non-esterified Fatty Acids
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Secondary
Non-HDL-Cholesterol
Calculated by subtracting HDL-cholesterol from total cholesterol. Change: end of test phase - start of trial
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Population: Retention rate was 90%, with 148 of 164 participants completing the study and 147 included in the analysis (after a priori exclusion of one participant who developed hypothyroidism).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Low Carbohydrate Diet | Non-HDL-Cholesterol | Start of trial | 101.5 mg/dL |
| Low Carbohydrate Diet | Non-HDL-Cholesterol | Change | 6.3 mg/dL |
| Moderate Carbohydrate Diet | Non-HDL-Cholesterol | Start of trial | 99.0 mg/dL |
| Moderate Carbohydrate Diet | Non-HDL-Cholesterol | Change | 11.0 mg/dL |
| High Carbohydrate Diet | Non-HDL-Cholesterol | Start of trial | 98.2 mg/dL |
| High Carbohydrate Diet | Non-HDL-Cholesterol | Change | 9.5 mg/dL |
Secondary
Physical Activity, Assessed by Accelerometry
Actigraph Accelerometer Change: average (midpoint of test phase, end of test phase) - start of trial An Actigraph Accelerometer measures movement, similar to a pedometer. Data are reported as counts (divided by 1,000) per day. Each participant wore the the accelerometer on the right hip for 7 days at each time point.
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Population: Intention-to-treat analysis
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Low Carbohydrate Diet | Physical Activity, Assessed by Accelerometry | Start of Trial | 495.8 counts/d |
| Low Carbohydrate Diet | Physical Activity, Assessed by Accelerometry | Change | -6.9 counts/d |
| Moderate Carbohydrate Diet | Physical Activity, Assessed by Accelerometry | Start of Trial | 463.8 counts/d |
| Moderate Carbohydrate Diet | Physical Activity, Assessed by Accelerometry | Change | -42.4 counts/d |
| High Carbohydrate Diet | Physical Activity, Assessed by Accelerometry | Start of Trial | 476.6 counts/d |
| High Carbohydrate Diet | Physical Activity, Assessed by Accelerometry | Change | -26.3 counts/d |
Secondary
Plasminogen Activator Inhibitor-1 (% Change)
Plasminogen activator inhibitor-1 levels were log transformed for analysis. Change (expressed in percentage units, 100%×(exp(change in log)-1)): end of test phase - start of trial
Time frame: Change through 20 weeks' weight loss maintenance
Population: Retention rate was 90%, with 148 of 164 participants completing the study and 147 included in the analysis (after a priori exclusion of one participant who developed hypothyroidism).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Low Carbohydrate Diet | Plasminogen Activator Inhibitor-1 (% Change) | 7.2 % change |
| Moderate Carbohydrate Diet | Plasminogen Activator Inhibitor-1 (% Change) | 26.9 % change |
| High Carbohydrate Diet | Plasminogen Activator Inhibitor-1 (% Change) | 14.9 % change |
Secondary
Plasminogen Activator Inhibitor-1 (Start of Trial)
Plasminogen activator inhibitor-1 levels were log transformed for analysis. For reporting, the adjusted means and 95% Confidence Intervals were retransformed to the original units (exp(mean log)±exp(mean log)×(exp(SE log)-1)). Changes (see Outcome 27) are expressed in percentage units (100%×(exp(change in log)-1)): end of test phase - start of trial
Time frame: Start of trial (time of randomization, post-weight loss)
Population: Retention rate was 90%, with 148 of 164 participants completing the study and 147 included in the analysis (after a priori exclusion of one participant who developed hypothyroidism).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Low Carbohydrate Diet | Plasminogen Activator Inhibitor-1 (Start of Trial) | 1.1 ng/mL |
| Moderate Carbohydrate Diet | Plasminogen Activator Inhibitor-1 (Start of Trial) | 1.5 ng/mL |
| High Carbohydrate Diet | Plasminogen Activator Inhibitor-1 (Start of Trial) | 1.2 ng/mL |
Secondary
Resting Energy Expenditure, Assessed by Indirect Calorimetry Using Respiratory Gas Exchange
Resting energy expenditure, assessed by indirect calorimetry using respiratory gas exchange Calories burned while resting: Participants lied down with head and neck under a clear plastic bubble, breathing room air. Gases in expired air were collected. Change: average (midpoint of test phase, end of test phase) - start of trial
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Population: Intention-to-treat analysis
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Low Carbohydrate Diet | Resting Energy Expenditure, Assessed by Indirect Calorimetry Using Respiratory Gas Exchange | Start of Trial | 1615 kcal/d |
| Low Carbohydrate Diet | Resting Energy Expenditure, Assessed by Indirect Calorimetry Using Respiratory Gas Exchange | Change | 54 kcal/d |
| Moderate Carbohydrate Diet | Resting Energy Expenditure, Assessed by Indirect Calorimetry Using Respiratory Gas Exchange | Start of Trial | 1576 kcal/d |
| Moderate Carbohydrate Diet | Resting Energy Expenditure, Assessed by Indirect Calorimetry Using Respiratory Gas Exchange | Change | 46 kcal/d |
| High Carbohydrate Diet | Resting Energy Expenditure, Assessed by Indirect Calorimetry Using Respiratory Gas Exchange | Start of Trial | 1603 kcal/d |
| High Carbohydrate Diet | Resting Energy Expenditure, Assessed by Indirect Calorimetry Using Respiratory Gas Exchange | Change | 34 kcal/d |
Secondary
Reverse T3
thyroid function test, inactive form of triiodothyronine (T3) Lifespan Bio kit was used for analysis. The range of this kit is 250 to 5000 pg/mL, which varies from other commercially available kits (about 10-fold greater values).
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Population: Descriptive data, reflecting participant flow End of test phase (N=148, completers minus 1 participant in the High carbohydrate diet group for whom reverse T3 result is missing)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Low Carbohydrate Diet | Reverse T3 | Start of trial | 1545 pg/mL |
| Low Carbohydrate Diet | Reverse T3 | Pre-weight loss | 1499 pg/mL |
| Low Carbohydrate Diet | Reverse T3 | End of test phase | 1557 pg/mL |
| Moderate Carbohydrate Diet | Reverse T3 | Start of trial | 1554 pg/mL |
| Moderate Carbohydrate Diet | Reverse T3 | Pre-weight loss | 1548 pg/mL |
| Moderate Carbohydrate Diet | Reverse T3 | End of test phase | 1572 pg/mL |
| High Carbohydrate Diet | Reverse T3 | Pre-weight loss | 1536 pg/mL |
| High Carbohydrate Diet | Reverse T3 | End of test phase | 1546 pg/mL |
| High Carbohydrate Diet | Reverse T3 | Start of trial | 1548 pg/mL |
Secondary
Serum Ketones/Ketoacids
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Secondary
Serum Metabolomics Profile
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Secondary
Skeletal Muscle Work Efficiency
Efficiency is expressed as percentage ratio of power generated during cycle ergometry (with conversion of Watts to kcal/min using a factor of 0.01433) to energy expenditure above resting. Change: end of test phase - start of trial.
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Low Carbohydrate Diet | Skeletal Muscle Work Efficiency | Change | 0.3 % power generated to energy expended |
| Low Carbohydrate Diet | Skeletal Muscle Work Efficiency | Start of Trial | 12.2 % power generated to energy expended |
| Moderate Carbohydrate Diet | Skeletal Muscle Work Efficiency | Start of Trial | 11.7 % power generated to energy expended |
| Moderate Carbohydrate Diet | Skeletal Muscle Work Efficiency | Change | -0.0 % power generated to energy expended |
| High Carbohydrate Diet | Skeletal Muscle Work Efficiency | Start of Trial | 12.2 % power generated to energy expended |
| High Carbohydrate Diet | Skeletal Muscle Work Efficiency | Change | -0.1 % power generated to energy expended |
Secondary
Testosterone
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Secondary
Thyroid Stimulating Hormone
Produced by the pituitary gland in the brain. Tells the thyroid gland to make thyroid hormones.
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Population: Descriptive data, reflecting participant flow End of test phase (N=148, completers)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Low Carbohydrate Diet | Thyroid Stimulating Hormone | Start of trial | 2.1 ulU/ml |
| Low Carbohydrate Diet | Thyroid Stimulating Hormone | Pre-weight loss | 2.0 ulU/ml |
| Low Carbohydrate Diet | Thyroid Stimulating Hormone | End of test phase | 2.0 ulU/ml |
| Moderate Carbohydrate Diet | Thyroid Stimulating Hormone | Start of trial | 2.2 ulU/ml |
| Moderate Carbohydrate Diet | Thyroid Stimulating Hormone | Pre-weight loss | 1.8 ulU/ml |
| Moderate Carbohydrate Diet | Thyroid Stimulating Hormone | End of test phase | 1.7 ulU/ml |
| High Carbohydrate Diet | Thyroid Stimulating Hormone | Pre-weight loss | 2.1 ulU/ml |
| High Carbohydrate Diet | Thyroid Stimulating Hormone | End of test phase | 2.1 ulU/ml |
| High Carbohydrate Diet | Thyroid Stimulating Hormone | Start of trial | 2.5 ulU/ml |
Secondary
Thyroxine (T4)
thyroid function test
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Population: Descriptive data, reflecting participant flow End of test phase (N=148, completers)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Low Carbohydrate Diet | Thyroxine (T4) | Start of trial | 84 nmol/L |
| Low Carbohydrate Diet | Thyroxine (T4) | Pre-weight loss | 85 nmol/L |
| Low Carbohydrate Diet | Thyroxine (T4) | End of test phase | 85 nmol/L |
| Moderate Carbohydrate Diet | Thyroxine (T4) | Start of trial | 85 nmol/L |
| Moderate Carbohydrate Diet | Thyroxine (T4) | Pre-weight loss | 86 nmol/L |
| Moderate Carbohydrate Diet | Thyroxine (T4) | End of test phase | 86 nmol/L |
| High Carbohydrate Diet | Thyroxine (T4) | Pre-weight loss | 90 nmol/L |
| High Carbohydrate Diet | Thyroxine (T4) | End of test phase | 85 nmol/L |
| High Carbohydrate Diet | Thyroxine (T4) | Start of trial | 86 nmol/L |
Secondary
Total Cholesterol
Change: end of test phase - start of trial
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Population: Retention rate was 90%, with 148 of 164 participants completing the study and 147 included in the analysis (after a priori exclusion of one participant who developed hypothyroidism).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Low Carbohydrate Diet | Total Cholesterol | Change | 16.1 mg/dL |
| Low Carbohydrate Diet | Total Cholesterol | Start of trial | 147.5 mg/dL |
| Moderate Carbohydrate Diet | Total Cholesterol | Start of trial | 145.5 mg/dL |
| Moderate Carbohydrate Diet | Total Cholesterol | Change | 18.5 mg/dL |
| High Carbohydrate Diet | Total Cholesterol | Start of trial | 142.9 mg/dL |
| High Carbohydrate Diet | Total Cholesterol | Change | 16.2 mg/dL |
Secondary
Triglycerides
Triglyceride levels were log transformed for analysis. For reporting, the adjusted means and 95% Confidence Intervals were retransformed to the original units Change, 10 weeks: midpoint of test phase - start of trial Change, 20 weeks: end of test phase - start of trial
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Low Carbohydrate Diet | Triglycerides | Change, 10 weeks | -12.1 md/dL |
| Low Carbohydrate Diet | Triglycerides | Start of Trial | 77.3 md/dL |
| Low Carbohydrate Diet | Triglycerides | Change, 20 weeks | -12.8 md/dL |
| Moderate Carbohydrate Diet | Triglycerides | Change, 10 weeks | 8.4 md/dL |
| Moderate Carbohydrate Diet | Triglycerides | Start of Trial | 76.5 md/dL |
| Moderate Carbohydrate Diet | Triglycerides | Change, 20 weeks | -0.1 md/dL |
| High Carbohydrate Diet | Triglycerides | Start of Trial | 80.5 md/dL |
| High Carbohydrate Diet | Triglycerides | Change, 20 weeks | 7.5 md/dL |
| High Carbohydrate Diet | Triglycerides | Change, 10 weeks | 10.9 md/dL |
Secondary
Urinary Catecholamine - Adrenaline
catecholamine excreted in the urine over 24 hours, also known as epinephrine
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Population: Descriptive data, reflecting participant flow End of test phase (N=148, completers)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Low Carbohydrate Diet | Urinary Catecholamine - Adrenaline | Start of trial | 3.5 mcg/day |
| Low Carbohydrate Diet | Urinary Catecholamine - Adrenaline | Pre-weight loss | 3.1 mcg/day |
| Low Carbohydrate Diet | Urinary Catecholamine - Adrenaline | End of test phase | 3.6 mcg/day |
| Moderate Carbohydrate Diet | Urinary Catecholamine - Adrenaline | Start of trial | 3.2 mcg/day |
| Moderate Carbohydrate Diet | Urinary Catecholamine - Adrenaline | Pre-weight loss | 3.0 mcg/day |
| Moderate Carbohydrate Diet | Urinary Catecholamine - Adrenaline | End of test phase | 3.4 mcg/day |
| High Carbohydrate Diet | Urinary Catecholamine - Adrenaline | Pre-weight loss | 2.9 mcg/day |
| High Carbohydrate Diet | Urinary Catecholamine - Adrenaline | End of test phase | 3.1 mcg/day |
| High Carbohydrate Diet | Urinary Catecholamine - Adrenaline | Start of trial | 3.0 mcg/day |
Secondary
Urinary Catecholamine - Dopamine
catecholamine excreted in the urine over 24 hours
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Population: Descriptive data, reflecting participant flow End of test phase (N=148, completers)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Low Carbohydrate Diet | Urinary Catecholamine - Dopamine | Pre-weight loss | 142.0 mcg/day |
| Low Carbohydrate Diet | Urinary Catecholamine - Dopamine | End of test phase | 123.0 mcg/day |
| Low Carbohydrate Diet | Urinary Catecholamine - Dopamine | Start of trial | 112.9 mcg/day |
| Moderate Carbohydrate Diet | Urinary Catecholamine - Dopamine | Pre-weight loss | 143.2 mcg/day |
| Moderate Carbohydrate Diet | Urinary Catecholamine - Dopamine | Start of trial | 112.4 mcg/day |
| Moderate Carbohydrate Diet | Urinary Catecholamine - Dopamine | End of test phase | 112.9 mcg/day |
| High Carbohydrate Diet | Urinary Catecholamine - Dopamine | Pre-weight loss | 117.8 mcg/day |
| High Carbohydrate Diet | Urinary Catecholamine - Dopamine | End of test phase | 104.7 mcg/day |
| High Carbohydrate Diet | Urinary Catecholamine - Dopamine | Start of trial | 104.7 mcg/day |
Secondary
Urinary Catecholamine - Noradrenaline
catecholamine excreted in the urine over 24 hours, also known as norepinephrine
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Population: Descriptive data, reflecting participant flow End of test phase (N=148, completers)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Low Carbohydrate Diet | Urinary Catecholamine - Noradrenaline | End of test phase | 27.4 mcg/day |
| Low Carbohydrate Diet | Urinary Catecholamine - Noradrenaline | Pre-weight loss | 25.8 mcg/day |
| Low Carbohydrate Diet | Urinary Catecholamine - Noradrenaline | Start of trial | 25.2 mcg/day |
| Moderate Carbohydrate Diet | Urinary Catecholamine - Noradrenaline | Start of trial | 25.3 mcg/day |
| Moderate Carbohydrate Diet | Urinary Catecholamine - Noradrenaline | End of test phase | 26.1 mcg/day |
| Moderate Carbohydrate Diet | Urinary Catecholamine - Noradrenaline | Pre-weight loss | 23.9 mcg/day |
| High Carbohydrate Diet | Urinary Catecholamine - Noradrenaline | Pre-weight loss | 25.3 mcg/day |
| High Carbohydrate Diet | Urinary Catecholamine - Noradrenaline | End of test phase | 26.0 mcg/day |
| High Carbohydrate Diet | Urinary Catecholamine - Noradrenaline | Start of trial | 24.7 mcg/day |
Secondary
Urinary Cortisol Excretion
cortisol (stress hormone) excreted in the urine over a 24-hour period
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Population: Descriptive data, reflecting participant flow End of test phase (N=148, completers)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Low Carbohydrate Diet | Urinary Cortisol Excretion | Start of trial | 66 μg/d |
| Low Carbohydrate Diet | Urinary Cortisol Excretion | Pre-weight loss | 61 μg/d |
| Low Carbohydrate Diet | Urinary Cortisol Excretion | End of test phase | 78 μg/d |
| Moderate Carbohydrate Diet | Urinary Cortisol Excretion | Start of trial | 64 μg/d |
| Moderate Carbohydrate Diet | Urinary Cortisol Excretion | Pre-weight loss | 59 μg/d |
| Moderate Carbohydrate Diet | Urinary Cortisol Excretion | End of test phase | 64 μg/d |
| High Carbohydrate Diet | Urinary Cortisol Excretion | Pre-weight loss | 63 μg/d |
| High Carbohydrate Diet | Urinary Cortisol Excretion | End of test phase | 64 μg/d |
| High Carbohydrate Diet | Urinary Cortisol Excretion | Start of trial | 63 μg/d |
Other Pre-specified
Effect Modification by Amylase Gene Copy Number
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Other Pre-specified
Effect Modification by Insulin Resistance of Metabolic Responses to Diet
Time frame: Start of (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Other Pre-specified
Effect Modification by Insulin Secretion of Metabolic Responses to Diet
Effect modifier: Insulin level 30 minutes into an standard OGTT (Insulin-30) Outcome: Total Energy Expenditure Tertiles: Pre-weight-loss Insulin-30 (Low, Moderate, High) Change: average (midpoint of test phase, end of test phase) - start of trial
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Population: The outcome is Effect Modification by Insulin Secretion. Thus,participants were divided into tertiles of Insulin-30.~Tertile I: Low=17, Moderate=16, High=22 Tertile II: Low=15, Moderate=22, High=17 Tertile III: Low=24, Moderate=14, High=15
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Low Carbohydrate Diet | Effect Modification by Insulin Secretion of Metabolic Responses to Diet | Start of Trial, Low Insulin-30 | 2795 kcal/d |
| Low Carbohydrate Diet | Effect Modification by Insulin Secretion of Metabolic Responses to Diet | Change, Low Insulin-30 | 147 kcal/d |
| Low Carbohydrate Diet | Effect Modification by Insulin Secretion of Metabolic Responses to Diet | Start of Trial, Moderate Insulin-30 | 2816 kcal/d |
| Low Carbohydrate Diet | Effect Modification by Insulin Secretion of Metabolic Responses to Diet | Change, Moderate Insulin-30 | 114 kcal/d |
| Low Carbohydrate Diet | Effect Modification by Insulin Secretion of Metabolic Responses to Diet | Start of Trial, High Insulin-30 | 2643 kcal/d |
| Low Carbohydrate Diet | Effect Modification by Insulin Secretion of Metabolic Responses to Diet | Change, High Insulin-30 | 271 kcal/d |
| Moderate Carbohydrate Diet | Effect Modification by Insulin Secretion of Metabolic Responses to Diet | Change, High Insulin-30 | 141 kcal/d |
| Moderate Carbohydrate Diet | Effect Modification by Insulin Secretion of Metabolic Responses to Diet | Start of Trial, Low Insulin-30 | 2673 kcal/d |
| Moderate Carbohydrate Diet | Effect Modification by Insulin Secretion of Metabolic Responses to Diet | Change, Moderate Insulin-30 | -5 kcal/d |
| Moderate Carbohydrate Diet | Effect Modification by Insulin Secretion of Metabolic Responses to Diet | Start of Trial, High Insulin-30 | 2281 kcal/d |
| Moderate Carbohydrate Diet | Effect Modification by Insulin Secretion of Metabolic Responses to Diet | Change, Low Insulin-30 | 103 kcal/d |
| Moderate Carbohydrate Diet | Effect Modification by Insulin Secretion of Metabolic Responses to Diet | Start of Trial, Moderate Insulin-30 | 2563 kcal/d |
| High Carbohydrate Diet | Effect Modification by Insulin Secretion of Metabolic Responses to Diet | Change, Low Insulin-30 | 15 kcal/d |
| High Carbohydrate Diet | Effect Modification by Insulin Secretion of Metabolic Responses to Diet | Start of Trial, Moderate Insulin-30 | 2782 kcal/d |
| High Carbohydrate Diet | Effect Modification by Insulin Secretion of Metabolic Responses to Diet | Change, High Insulin-30 | -37 kcal/d |
| High Carbohydrate Diet | Effect Modification by Insulin Secretion of Metabolic Responses to Diet | Change, Moderate Insulin-30 | -50 kcal/d |
| High Carbohydrate Diet | Effect Modification by Insulin Secretion of Metabolic Responses to Diet | Start of Trial, Low Insulin-30 | 2647 kcal/d |
| High Carbohydrate Diet | Effect Modification by Insulin Secretion of Metabolic Responses to Diet | Start of Trial, High Insulin-30 | 2544 kcal/d |