Blood Pressure, Body Composition, Cardiovascular Diseases, Obesity
Conditions
Brief summary
The objective of this trial is to examine the long-term effects of a diet low in carbohydrates, as compared to one low in fat, on cardiovascular disease risk factors, including blood pressure (BP), body weight and composition, serum lipids, plasma glucose, insulin, adipocytokines (adiponectin, leptin, resistin), and C-reactive protein (CRP) among obese adults. The investigators will test the following hypotheses: Hypothesis 1: Compared to a low fat diet, a diet low in carbohydrates will reduce systolic and diastolic BP over 12 months; Hypothesis 2: Compared to a low fat diet, a diet low in carbohydrates will reduce body weight, total percent body fat, and waist circumference over 12 months; Hypothesis 3: Compared to a low fat diet, a diet low in carbohydrates will reduce serum levels of LDL-cholesterol and triglycerides and increase serum levels of HDL-cholesterol over 12 months; Hypothesis 4: Compared to a low fat diet, a diet low in carbohydrates will reduce plasma levels of glucose and insulin levels over 12 months; and Hypothesis 5: Compared to a low fat diet, a diet low in carbohydrates will reduce plasma levels of leptin, resistin, and CRP and increase plasma levels of adiponectin over 12 months.
Detailed description
Cardiovascular diseases (CVD) remain the leading cause of death globally as well as here in the United States. Manipulations of the macronutrient (protein, carbohydrate and fat) contents of diet have been used extensively for weight loss and weight control in the past several decades. Low carbohydrate diets, in particular, have gained popularity for weight loss. However, few studies have examined the effects of a diet low in carbohydrates on traditional and novel cardiovascular risk factors in the long term, particularly in contrast to the current dietary recommendations for decreased fat intake to reduce risk of CVD. In this proposal, we plan to conduct a 12-month, parallel-arm, randomized controlled trial of a diet low in carbohydrates versus the currently recommended low fat diet to reduce CVD risk factors among obese adults. The objective of this trial is to examine the long-term effects of a diet low in carbohydrates, as compared to one low in fat, on CVD risk factors, including blood pressure (BP), body weight and composition, serum lipids, plasma glucose, insulin, adipocytokines (adiponectin, leptin, resistin), and C-reactive protein (CRP) among obese adults. In order to accomplish these objectives we will randomize 130 eligible participants (n=65 in each group) to consume either a diet low in carbohydrates (≤40 g/d) or a diet low in fat (\<7% saturated fat, \<30% total fat). Neither of the diets will be energy-restricted. Participants will meet with a dietitian for one-on-one counseling sessions weekly for the first 4 weeks, then bi-monthly in small group sessions for the next 5 months, and monthly in larger group sessions for the final 6 months of the intervention. Data on both traditional and novel CVD risk factors will be collected at baseline, 3, 6, and 12 months. We hypothesize that a diet low in carbohydrates as compared to a diet low in fat will lower systolic and diastolic BP, body weight, total percent body fat, waist circumference, serum levels of triglycerides, and plasma levels of insulin, glucose, leptin, resistin, and CRP, and increase serum levels of HDL-cholesterol and adiponectin. Because CVD is the most common cause of death here in the U.S. and world-wide, this study has important public health implications. It will provide new information on the potential long-term effects of diets low in carbohydrates on both the traditional risk factors for CVD as well as novel risk factors and inflammatory factors. The results from this study will help to determine if a diet low in carbohydrates as compared to the currently recommended low fat diet can decrease the risk of CVD among obese adults.
Interventions
BEHAVIORALlow carbohydrate diet
\<40 grams carbohydrate/day
BEHAVIORALlow fat diet
\<30% fat, \<7% saturated fat
Sponsors
Tulane University Health Sciences Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Men or women aged 22 - 75 years, any race/ethnicity * BMI of 30 - 45 k/m2 * Willing and able to provide informed consent
Exclusion criteria
* History of self-reported clinical CVD (angina/myocardial infarction, coronary revascularization, heart failure, stroke/transient ischemic attack, peripheral arterial disease) * Medical condition in which a low-carbohydrate diet may not be advised (diabetes, renal disease, cancer requiring treatment during the past year, osteoporosis, untreated thyroid disease, gout) * Current use of more than 2 antihypertensive or more than 2 cholesterol-lowering medications * For women, current pregnancy or breastfeeding or plans to become pregnant during the study period * Consumption of more than 21 alcoholic beverages per week * Currently on a diet or using prescription weight loss medications, underwent weight loss surgery, and/or experienced weight loss \>15 pounds within 6 months of study entry * Plans to move out of the study area (\>1 hour from study site) or difficulty to come to the study site * Participation of another household member in the study; employees or persons living with employees of the study * Participation in other lifestyle intervention trials currently * At the discretion of the study coordinator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Predicted Mean Difference in Body Weight From Baseline, by Assigned Dietary Group | 12 months | Predicted mean difference from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values. |
| Predicted Mean Differences in Lean Mass From Baseline, by Assigned Dietary Group | 12 months | Mean Difference in Lean Mass predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values. |
| Predicted Mean Differences in Fat Mass From Baseline, by Assigned Dietary Group | 12 months | Mean Difference in Fat Mass predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values. |
| Predicted Mean Differences of Waist Circumference From Baseline, by Assigned Dietary Group | 12 months | Predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values. |
| Predicted Mean Differences in Total Cholesterol Level From Baseline by Assigned Dietary Group | 12 months | Predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values. |
| Predicted Mean Differences in LDL Cholesterol Level From Baseline, by Assigned Dietary Group | 12 months | Predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values. |
| Predicted Mean Differences in HDL Cholesterol From Baseline, by Assigned Dietary Group | 12 months | Predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values. |
| Predicted Mean Differences in Total-HDL Cholesterol Ratio From Baseline, by Assigned Dietary Group | 12 months | Predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values. |
| Predicted Mean Differences in Triglycerides From Baseline, by Assigned Dietary Group | 12 months | Predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values. |
| Predicted Mean Differences in Systolic Blood Pressure From Baseline, by Assigned Dietary Group | 12 months | Predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values. |
| Predicted Mean Difference in Diastolic Blood Pressure, by Assigned Dietary Group | 12 Months | Mean Difference in Diastolic Blood Pressure predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values |
| Predicted Mean Difference in Plasma Glucose Level, by Assigned Dietary Group | 12 months | Mean Difference in Plasma Glucose Level predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values. |
| Predicted Mean Differences in Serum Insulin Level From Baseline, by Assigned Dietary Group | 12 months | Mean Difference in Serum Insulin Level predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values. |
| Predicted Mean Differences in C-reactive Protein Level From Baseline, by Assigned Dietary Group | 12 Months | Mean Difference in C-reactive Protein Level predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values |
| Predicted Mean Differences in Serum Creatinine Level From Baseline, by Assigned Dietary Group | 12 Months | Mean Difference in Serum Creatinine Level predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values. |
| Predicted Mean Differences of 10-y Framingham Risk Score From Baseline, by Assigned Dietary Group | 12 Months | Mean Difference in 10-y Framingham Risk Score predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Low Carbohydrate Diet low carbohydrate diet: \<40 grams carbohydrate/day | 75 |
| Low Fat Diet low fat diet: \<30% fat, \<7% saturated fat | 73 |
| Total | 148 |
Baseline characteristics
| Characteristic | Low Carbohydrate Diet | Low Fat Diet | Total |
|---|---|---|---|
| Age, Continuous | 45.8 years STANDARD_DEVIATION 9.9 | 47.8 years STANDARD_DEVIATION 10.4 | 46.8 years STANDARD_DEVIATION 10.2 |
| body composition Fat mass | 40 % STANDARD_DEVIATION 10 | 40 % STANDARD_DEVIATION 10 | 40 % STANDARD_DEVIATION 10 |
| body composition Lean Mass | 60 % STANDARD_DEVIATION 10 | 60 % STANDARD_DEVIATION 10 | 60 % STANDARD_DEVIATION 10 |
| body mass index | 35.2 kg/m**2 STANDARD_DEVIATION 3.8 | 35.6 kg/m**2 STANDARD_DEVIATION 4.5 | 35.4 kg/m**2 STANDARD_DEVIATION 4.2 |
| body weight | 96.3 kg STANDARD_DEVIATION 12.7 | 97.9 kg STANDARD_DEVIATION 13.5 | 97.1 kg STANDARD_DEVIATION 13.1 |
| C-reactive protein | 46.7 nmol/L STANDARD_DEVIATION 40 | 46.7 nmol/L STANDARD_DEVIATION 48.6 | 46.7 nmol/L STANDARD_DEVIATION 44.5 |
| diastolic blood pressure | 77.5 mm Hg STANDARD_DEVIATION 9 | 79.4 mm Hg STANDARD_DEVIATION 8.3 | 78.4 mm Hg STANDARD_DEVIATION 8.7 |
| Framingham risk percent | 3.9 % STANDARD_DEVIATION 3.1 | 4.2 % STANDARD_DEVIATION 3.3 | 4.0 % STANDARD_DEVIATION 18.7 |
| HDL cholesterol | 53.8 mg/dL STANDARD_DEVIATION 13.3 | 56.5 mg/dL STANDARD_DEVIATION 12.8 | 55.1 mg/dL STANDARD_DEVIATION 13.1 |
| LDL cholesterol | 122.5 mg/dL STANDARD_DEVIATION 34.6 | 122.7 mg/dL STANDARD_DEVIATION 38.6 | 122.6 mg/dL STANDARD_DEVIATION 36.6 |
| Medication use Antihypertensive | 21 Participants | 24 Participants | 45 Participants |
| Medication use Lipid-Lowering | 12 Participants | 9 Participants | 21 Participants |
| Physical activity level | 16.3 MET-h/wk STANDARD_DEVIATION 26 | 19.6 MET-h/wk STANDARD_DEVIATION 35.5 | 17.9 MET-h/wk STANDARD_DEVIATION 31.1 |
| plasma glucose | 94.5 mg/dL STANDARD_DEVIATION 10.9 | 93.4 mg/dL STANDARD_DEVIATION 9.2 | 94.0 mg/dL STANDARD_DEVIATION 10.1 |
| Race/Ethnicity, Customized Asian | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Black | 40 Participants | 36 Participants | 76 Participants |
| Race/Ethnicity, Customized Hispanic | 0 Participants | 3 Participants | 3 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 34 Participants | 33 Participants | 67 Participants |
| serum creatinine | 1.0 mg/dL STANDARD_DEVIATION 0.2 | 1.1 mg/dL STANDARD_DEVIATION 0.2 | 1.0 mg/dL STANDARD_DEVIATION 0.1 |
| serum insulin | 102.8 pmol/L STANDARD_DEVIATION 63.9 | 105.6 pmol/L STANDARD_DEVIATION 54.9 | 104.2 pmol/L STANDARD_DEVIATION 59.7 |
| Sex: Female, Male Female | 66 Participants | 65 Participants | 131 Participants |
| Sex: Female, Male Male | 9 Participants | 8 Participants | 17 Participants |
| systolic blood pressure | 120.3 mm Hg STANDARD_DEVIATION 12.8 | 124.9 mm Hg STANDARD_DEVIATION 13.8 | 122.6 mm Hg STANDARD_DEVIATION 13.5 |
| total cholesterol | 198.8 mg/dL STANDARD_DEVIATION 42.2 | 204.3 mg/dL STANDARD_DEVIATION 40.7 | 201.5 mg/dL STANDARD_DEVIATION 41.5 |
| total-HDL cholesterol ratio | 3.8 unitless STANDARD_DEVIATION 1 | 3.8 unitless STANDARD_DEVIATION 1 | 3.8 unitless STANDARD_DEVIATION 1 |
| triglycerides | 112.6 mg/dL STANDARD_DEVIATION 54.1 | 125.5 mg/dL STANDARD_DEVIATION 81.3 | 119.0 mg/dL STANDARD_DEVIATION 69.1 |
| waist circumference | 108.4 cm STANDARD_DEVIATION 9.3 | 111.0 cm STANDARD_DEVIATION 10.7 | 109.7 cm STANDARD_DEVIATION 10.1 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 19 / 75 | 23 / 73 |
| serious Total, serious adverse events | 0 / 75 | 0 / 73 |
Outcome results
Primary
Predicted Mean Difference in Body Weight From Baseline, by Assigned Dietary Group
Predicted mean difference from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Low Carbohydrate Diet | Predicted Mean Difference in Body Weight From Baseline, by Assigned Dietary Group | Change in body weight after 3 months | -5.7 kg |
| Low Carbohydrate Diet | Predicted Mean Difference in Body Weight From Baseline, by Assigned Dietary Group | Change in body weight after 6 months | -5.6 kg |
| Low Carbohydrate Diet | Predicted Mean Difference in Body Weight From Baseline, by Assigned Dietary Group | Change in body weight after 12 months | -5.3 kg |
| Low Fat Diet | Predicted Mean Difference in Body Weight From Baseline, by Assigned Dietary Group | Change in body weight after 3 months | -2.6 kg |
| Low Fat Diet | Predicted Mean Difference in Body Weight From Baseline, by Assigned Dietary Group | Change in body weight after 6 months | -2.3 kg |
| Low Fat Diet | Predicted Mean Difference in Body Weight From Baseline, by Assigned Dietary Group | Change in body weight after 12 months | -1.8 kg |
Primary
Predicted Mean Difference in Diastolic Blood Pressure, by Assigned Dietary Group
Mean Difference in Diastolic Blood Pressure predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values
Time frame: 12 Months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Low Carbohydrate Diet | Predicted Mean Difference in Diastolic Blood Pressure, by Assigned Dietary Group | Change in Diastolic Blood Pressure after 3 mo | -2.3 mm Hg |
| Low Carbohydrate Diet | Predicted Mean Difference in Diastolic Blood Pressure, by Assigned Dietary Group | Change in Diastolic Blood Pressure after 6 mo | -1.7 mm Hg |
| Low Carbohydrate Diet | Predicted Mean Difference in Diastolic Blood Pressure, by Assigned Dietary Group | Change in Diastolic Blood Pressure after 12 mo | -0.5 mm Hg |
| Low Fat Diet | Predicted Mean Difference in Diastolic Blood Pressure, by Assigned Dietary Group | Change in Diastolic Blood Pressure after 3 mo | -0.9 mm Hg |
| Low Fat Diet | Predicted Mean Difference in Diastolic Blood Pressure, by Assigned Dietary Group | Change in Diastolic Blood Pressure after 6 mo | -0.5 mm Hg |
| Low Fat Diet | Predicted Mean Difference in Diastolic Blood Pressure, by Assigned Dietary Group | Change in Diastolic Blood Pressure after 12 mo | 0.2 mm Hg |
Primary
Predicted Mean Difference in Plasma Glucose Level, by Assigned Dietary Group
Mean Difference in Plasma Glucose Level predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Low Carbohydrate Diet | Predicted Mean Difference in Plasma Glucose Level, by Assigned Dietary Group | Change in Plasma Glucose Level after 3 months | -0.05 mmol/L|| |
| Low Carbohydrate Diet | Predicted Mean Difference in Plasma Glucose Level, by Assigned Dietary Group | Change in Plasma Glucose Level after 6 months | 0.03 mmol/L|| |
| Low Carbohydrate Diet | Predicted Mean Difference in Plasma Glucose Level, by Assigned Dietary Group | Change in Plasma Glucose Level after 12 months | 0.02 mmol/L|| |
| Low Fat Diet | Predicted Mean Difference in Plasma Glucose Level, by Assigned Dietary Group | Change in Plasma Glucose Level after 3 months | -0.10 mmol/L|| |
| Low Fat Diet | Predicted Mean Difference in Plasma Glucose Level, by Assigned Dietary Group | Change in Plasma Glucose Level after 6 months | -0.10 mmol/L|| |
| Low Fat Diet | Predicted Mean Difference in Plasma Glucose Level, by Assigned Dietary Group | Change in Plasma Glucose Level after 12 months | -0.10 mmol/L|| |
Primary
Predicted Mean Differences in C-reactive Protein Level From Baseline, by Assigned Dietary Group
Mean Difference in C-reactive Protein Level predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values
Time frame: 12 Months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Low Carbohydrate Diet | Predicted Mean Differences in C-reactive Protein Level From Baseline, by Assigned Dietary Group | Change in Serum Creatinine Level after 3 mo | -4.8 nmol/L |
| Low Carbohydrate Diet | Predicted Mean Differences in C-reactive Protein Level From Baseline, by Assigned Dietary Group | Change in Serum Creatinine Level after 6 mo | -4.8 nmol/L |
| Low Carbohydrate Diet | Predicted Mean Differences in C-reactive Protein Level From Baseline, by Assigned Dietary Group | Change in Serum Creatinine Level after 12 mo | -6.7 nmol/L |
| Low Fat Diet | Predicted Mean Differences in C-reactive Protein Level From Baseline, by Assigned Dietary Group | Change in Serum Creatinine Level after 3 mo | 5.7 nmol/L |
| Low Fat Diet | Predicted Mean Differences in C-reactive Protein Level From Baseline, by Assigned Dietary Group | Change in Serum Creatinine Level after 6 mo | 6.7 nmol/L |
| Low Fat Diet | Predicted Mean Differences in C-reactive Protein Level From Baseline, by Assigned Dietary Group | Change in Serum Creatinine Level after 12 mo | 8.6 nmol/L |
Primary
Predicted Mean Differences in Fat Mass From Baseline, by Assigned Dietary Group
Mean Difference in Fat Mass predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Low Carbohydrate Diet | Predicted Mean Differences in Fat Mass From Baseline, by Assigned Dietary Group | Change of % fat mass after 3 months | -1.1 % body weight that is fat mass |
| Low Carbohydrate Diet | Predicted Mean Differences in Fat Mass From Baseline, by Assigned Dietary Group | Change of % fat mass after 6 months | -1.1 % body weight that is fat mass |
| Low Carbohydrate Diet | Predicted Mean Differences in Fat Mass From Baseline, by Assigned Dietary Group | Change of % fat mass after 12 months | -1.2 % body weight that is fat mass |
| Low Fat Diet | Predicted Mean Differences in Fat Mass From Baseline, by Assigned Dietary Group | Change of % fat mass after 3 months | -0.3 % body weight that is fat mass |
| Low Fat Diet | Predicted Mean Differences in Fat Mass From Baseline, by Assigned Dietary Group | Change of % fat mass after 6 months | -0.1 % body weight that is fat mass |
| Low Fat Diet | Predicted Mean Differences in Fat Mass From Baseline, by Assigned Dietary Group | Change of % fat mass after 12 months | 0.3 % body weight that is fat mass |
Primary
Predicted Mean Differences in HDL Cholesterol From Baseline, by Assigned Dietary Group
Predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Low Carbohydrate Diet | Predicted Mean Differences in HDL Cholesterol From Baseline, by Assigned Dietary Group | Change in HDL cholesterol level after 3 mo | 0.03 mmol/L |
| Low Carbohydrate Diet | Predicted Mean Differences in HDL Cholesterol From Baseline, by Assigned Dietary Group | Change in HDL cholesterol level after 6 mo | 0.10 mmol/L |
| Low Carbohydrate Diet | Predicted Mean Differences in HDL Cholesterol From Baseline, by Assigned Dietary Group | Change in HDL cholesterol level after 12 mo | 0.24 mmol/L |
| Low Fat Diet | Predicted Mean Differences in HDL Cholesterol From Baseline, by Assigned Dietary Group | Change in HDL cholesterol level after 3 mo | -0.03 mmol/L |
| Low Fat Diet | Predicted Mean Differences in HDL Cholesterol From Baseline, by Assigned Dietary Group | Change in HDL cholesterol level after 6 mo | -0.00 mmol/L |
| Low Fat Diet | Predicted Mean Differences in HDL Cholesterol From Baseline, by Assigned Dietary Group | Change in HDL cholesterol level after 12 mo | 0.06 mmol/L |
Primary
Predicted Mean Differences in LDL Cholesterol Level From Baseline, by Assigned Dietary Group
Predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Low Carbohydrate Diet | Predicted Mean Differences in LDL Cholesterol Level From Baseline, by Assigned Dietary Group | Change in LDL cholesterol level after 12 mo | -0.08 mmol/L |
| Low Carbohydrate Diet | Predicted Mean Differences in LDL Cholesterol Level From Baseline, by Assigned Dietary Group | Change in LDL cholesterol level after 3 mo | -0.02 mmol/L |
| Low Carbohydrate Diet | Predicted Mean Differences in LDL Cholesterol Level From Baseline, by Assigned Dietary Group | Change in LDL cholesterol level after 6 mo | -0.04 mmol/L |
| Low Fat Diet | Predicted Mean Differences in LDL Cholesterol Level From Baseline, by Assigned Dietary Group | Change in LDL cholesterol level after 12 mo | -0.05 mmol/L |
| Low Fat Diet | Predicted Mean Differences in LDL Cholesterol Level From Baseline, by Assigned Dietary Group | Change in LDL cholesterol level after 3 mo | 0.05 mmol/L |
| Low Fat Diet | Predicted Mean Differences in LDL Cholesterol Level From Baseline, by Assigned Dietary Group | Change in LDL cholesterol level after 6 mo | 0.02 mmol/L |
Primary
Predicted Mean Differences in Lean Mass From Baseline, by Assigned Dietary Group
Mean Difference in Lean Mass predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Low Carbohydrate Diet | Predicted Mean Differences in Lean Mass From Baseline, by Assigned Dietary Group | Change of % lean mass after 3 months | 1.6 % of body weight that is lean mass |
| Low Carbohydrate Diet | Predicted Mean Differences in Lean Mass From Baseline, by Assigned Dietary Group | Change of % lean mass after 6 months | 1.5 % of body weight that is lean mass |
| Low Carbohydrate Diet | Predicted Mean Differences in Lean Mass From Baseline, by Assigned Dietary Group | Change of % lean mass after 12 months | 1.3 % of body weight that is lean mass |
| Low Fat Diet | Predicted Mean Differences in Lean Mass From Baseline, by Assigned Dietary Group | Change of % lean mass after 3 months | 0.4 % of body weight that is lean mass |
| Low Fat Diet | Predicted Mean Differences in Lean Mass From Baseline, by Assigned Dietary Group | Change of % lean mass after 6 months | 0.2 % of body weight that is lean mass |
| Low Fat Diet | Predicted Mean Differences in Lean Mass From Baseline, by Assigned Dietary Group | Change of % lean mass after 12 months | -0.4 % of body weight that is lean mass |
Primary
Predicted Mean Differences in Serum Creatinine Level From Baseline, by Assigned Dietary Group
Mean Difference in Serum Creatinine Level predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.
Time frame: 12 Months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Low Carbohydrate Diet | Predicted Mean Differences in Serum Creatinine Level From Baseline, by Assigned Dietary Group | hange in Serum Creatinine Level after 3 mo | -0.1 µmol/L¶ |
| Low Carbohydrate Diet | Predicted Mean Differences in Serum Creatinine Level From Baseline, by Assigned Dietary Group | hange in Serum Creatinine Level after 6 mo | -3.1 µmol/L¶ |
| Low Carbohydrate Diet | Predicted Mean Differences in Serum Creatinine Level From Baseline, by Assigned Dietary Group | hange in Serum Creatinine Level after 12 mo | -9.2 µmol/L¶ |
| Low Fat Diet | Predicted Mean Differences in Serum Creatinine Level From Baseline, by Assigned Dietary Group | hange in Serum Creatinine Level after 3 mo | 1.8 µmol/L¶ |
| Low Fat Diet | Predicted Mean Differences in Serum Creatinine Level From Baseline, by Assigned Dietary Group | hange in Serum Creatinine Level after 6 mo | -1.7 µmol/L¶ |
| Low Fat Diet | Predicted Mean Differences in Serum Creatinine Level From Baseline, by Assigned Dietary Group | hange in Serum Creatinine Level after 12 mo | -8.5 µmol/L¶ |
Primary
Predicted Mean Differences in Serum Insulin Level From Baseline, by Assigned Dietary Group
Mean Difference in Serum Insulin Level predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Low Carbohydrate Diet | Predicted Mean Differences in Serum Insulin Level From Baseline, by Assigned Dietary Group | Change in Serum Insulin Level after 3 mo | -25.0 pmol/L |
| Low Carbohydrate Diet | Predicted Mean Differences in Serum Insulin Level From Baseline, by Assigned Dietary Group | Change in Serum Insulin Level after 6 mo | -21.5 pmol/L |
| Low Carbohydrate Diet | Predicted Mean Differences in Serum Insulin Level From Baseline, by Assigned Dietary Group | Change in Serum Insulin Level after 12 mo | -13.9 pmol/L |
| Low Fat Diet | Predicted Mean Differences in Serum Insulin Level From Baseline, by Assigned Dietary Group | Change in Serum Insulin Level after 3 mo | -18.8 pmol/L |
| Low Fat Diet | Predicted Mean Differences in Serum Insulin Level From Baseline, by Assigned Dietary Group | Change in Serum Insulin Level after 6 mo | -20.8 pmol/L |
| Low Fat Diet | Predicted Mean Differences in Serum Insulin Level From Baseline, by Assigned Dietary Group | Change in Serum Insulin Level after 12 mo | -24.3 pmol/L |
Primary
Predicted Mean Differences in Systolic Blood Pressure From Baseline, by Assigned Dietary Group
Predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Low Carbohydrate Diet | Predicted Mean Differences in Systolic Blood Pressure From Baseline, by Assigned Dietary Group | Change in Systolic Blood Pressure after 3 mo | -4.2 mm Hg |
| Low Carbohydrate Diet | Predicted Mean Differences in Systolic Blood Pressure From Baseline, by Assigned Dietary Group | Change in Systolic Blood Pressure after 6 mo | -2.9 mm Hg |
| Low Carbohydrate Diet | Predicted Mean Differences in Systolic Blood Pressure From Baseline, by Assigned Dietary Group | Change in Systolic Blood Pressure after 12 mo | -0.2 mm Hg |
| Low Fat Diet | Predicted Mean Differences in Systolic Blood Pressure From Baseline, by Assigned Dietary Group | Change in Systolic Blood Pressure after 3 mo | -2.6 mm Hg |
| Low Fat Diet | Predicted Mean Differences in Systolic Blood Pressure From Baseline, by Assigned Dietary Group | Change in Systolic Blood Pressure after 6 mo | -2.2 mm Hg |
| Low Fat Diet | Predicted Mean Differences in Systolic Blood Pressure From Baseline, by Assigned Dietary Group | Change in Systolic Blood Pressure after 12 mo | -1.3 mm Hg |
Primary
Predicted Mean Differences in Total Cholesterol Level From Baseline by Assigned Dietary Group
Predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Low Carbohydrate Diet | Predicted Mean Differences in Total Cholesterol Level From Baseline by Assigned Dietary Group | Change of total cholesterol after 3 mo | -0.09 mmol/L |
| Low Carbohydrate Diet | Predicted Mean Differences in Total Cholesterol Level From Baseline by Assigned Dietary Group | Change of total cholesterol after 6 mo | -0.04 mmol/L |
| Low Carbohydrate Diet | Predicted Mean Differences in Total Cholesterol Level From Baseline by Assigned Dietary Group | Change of total cholesterol after 12 mo | 0.05 mmol/L |
| Low Fat Diet | Predicted Mean Differences in Total Cholesterol Level From Baseline by Assigned Dietary Group | Change of total cholesterol after 3 mo | 0.03 mmol/L |
| Low Fat Diet | Predicted Mean Differences in Total Cholesterol Level From Baseline by Assigned Dietary Group | Change of total cholesterol after 6 mo | 0.03 mmol/L |
| Low Fat Diet | Predicted Mean Differences in Total Cholesterol Level From Baseline by Assigned Dietary Group | Change of total cholesterol after 12 mo | 0.03 mmol/L |
Primary
Predicted Mean Differences in Total-HDL Cholesterol Ratio From Baseline, by Assigned Dietary Group
Predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Low Carbohydrate Diet | Predicted Mean Differences in Total-HDL Cholesterol Ratio From Baseline, by Assigned Dietary Group | Change in Total-HDL cholesterol ratio after 3 mo | -0.13 ratio |
| Low Carbohydrate Diet | Predicted Mean Differences in Total-HDL Cholesterol Ratio From Baseline, by Assigned Dietary Group | Change in Total-HDL cholesterol ratio after 6 mo | -0.25 ratio |
| Low Carbohydrate Diet | Predicted Mean Differences in Total-HDL Cholesterol Ratio From Baseline, by Assigned Dietary Group | Change in Total-HDL cholesterol level after 12 mo | -0.49 ratio |
| Low Fat Diet | Predicted Mean Differences in Total-HDL Cholesterol Ratio From Baseline, by Assigned Dietary Group | Change in Total-HDL cholesterol ratio after 3 mo | 0.13 ratio |
| Low Fat Diet | Predicted Mean Differences in Total-HDL Cholesterol Ratio From Baseline, by Assigned Dietary Group | Change in Total-HDL cholesterol ratio after 6 mo | 0.07 ratio |
| Low Fat Diet | Predicted Mean Differences in Total-HDL Cholesterol Ratio From Baseline, by Assigned Dietary Group | Change in Total-HDL cholesterol level after 12 mo | -0.05 ratio |
Primary
Predicted Mean Differences in Triglycerides From Baseline, by Assigned Dietary Group
Predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Low Carbohydrate Diet | Predicted Mean Differences in Triglycerides From Baseline, by Assigned Dietary Group | Change in Triglycerides after 3 mo | -0.21 mmol/L |
| Low Carbohydrate Diet | Predicted Mean Differences in Triglycerides From Baseline, by Assigned Dietary Group | Change in Triglycerides after 6 mo | -0.22 mmol/L |
| Low Carbohydrate Diet | Predicted Mean Differences in Triglycerides From Baseline, by Assigned Dietary Group | Change in Triglycerides after 12 mo | -0.23 mmol/L |
| Low Fat Diet | Predicted Mean Differences in Triglycerides From Baseline, by Assigned Dietary Group | Change in Triglycerides after 3 mo | 0.03 mmol/L |
| Low Fat Diet | Predicted Mean Differences in Triglycerides From Baseline, by Assigned Dietary Group | Change in Triglycerides after 6 mo | -0.01 mmol/L |
| Low Fat Diet | Predicted Mean Differences in Triglycerides From Baseline, by Assigned Dietary Group | Change in Triglycerides after 12 mo | -0.07 mmol/L |
Primary
Predicted Mean Differences of 10-y Framingham Risk Score From Baseline, by Assigned Dietary Group
Mean Difference in 10-y Framingham Risk Score predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.
Time frame: 12 Months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Low Carbohydrate Diet | Predicted Mean Differences of 10-y Framingham Risk Score From Baseline, by Assigned Dietary Group | Change in 10-Y Framingham Risk Score after 3 mo | -0.5 % risk of developing CVD in next 10 yrs |
| Low Carbohydrate Diet | Predicted Mean Differences of 10-y Framingham Risk Score From Baseline, by Assigned Dietary Group | Change in 10-Y Framingham Risk Score after 6 mo | -0.7 % risk of developing CVD in next 10 yrs |
| Low Carbohydrate Diet | Predicted Mean Differences of 10-y Framingham Risk Score From Baseline, by Assigned Dietary Group | Change in 10-Y Framingham Risk Score after 12 mo | -1.0 % risk of developing CVD in next 10 yrs |
| Low Fat Diet | Predicted Mean Differences of 10-y Framingham Risk Score From Baseline, by Assigned Dietary Group | Change in 10-Y Framingham Risk Score after 3 mo | 0.4 % risk of developing CVD in next 10 yrs |
| Low Fat Diet | Predicted Mean Differences of 10-y Framingham Risk Score From Baseline, by Assigned Dietary Group | Change in 10-Y Framingham Risk Score after 6 mo | 0.4 % risk of developing CVD in next 10 yrs |
| Low Fat Diet | Predicted Mean Differences of 10-y Framingham Risk Score From Baseline, by Assigned Dietary Group | Change in 10-Y Framingham Risk Score after 12 mo | 0.4 % risk of developing CVD in next 10 yrs |
Primary
Predicted Mean Differences of Waist Circumference From Baseline, by Assigned Dietary Group
Predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Low Carbohydrate Diet | Predicted Mean Differences of Waist Circumference From Baseline, by Assigned Dietary Group | Change in waist circumference after 3 mo | -5.5 cm |
| Low Carbohydrate Diet | Predicted Mean Differences of Waist Circumference From Baseline, by Assigned Dietary Group | Change in waist circumference after 6 mo | -5.9 cm |
| Low Carbohydrate Diet | Predicted Mean Differences of Waist Circumference From Baseline, by Assigned Dietary Group | Change in waist circumference after 12 mo | -6.7 cm |
| Low Fat Diet | Predicted Mean Differences of Waist Circumference From Baseline, by Assigned Dietary Group | Change in waist circumference after 3 mo | -3.5 cm |
| Low Fat Diet | Predicted Mean Differences of Waist Circumference From Baseline, by Assigned Dietary Group | Change in waist circumference after 6 mo | -4.0 cm |
| Low Fat Diet | Predicted Mean Differences of Waist Circumference From Baseline, by Assigned Dietary Group | Change in waist circumference after 12 mo | -5.0 cm |