Skip to content

Effects of Low Fat Versus Low Carbohydrate Diets on Energy Metabolism

Effect of Low Fat Versus Low Carbohydrate Diets on Energy Metabolism

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03878108
Enrollment
21
Registered
2019-03-18
Start date
2019-04-15
Completion date
2020-09-01
Last updated
2021-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy, Healthy Volunteers

Keywords

Accelerometry, Body Composition, Body Weight Regulation, Calories, Energy Expenditure

Brief summary

Background: Researchers want to learn how different diets affect hormone levels, body weight, energy expenditure, liver fat, and more. To do this, they will use specialized techniques and food plans. This is not a weight loss study. Objective: To better understand how low-fat and low-carbohydrate foods affect health. Eligibility: Men and women ages 18-50 who have a stable body weight and can exercise daily Design: Participants will have a screening visit that lasts 4-6 hours. It will include: Medical history Physical exam Fasting blood and urine tests Questionnaires Trying foods from the study Participants will be admitted to the Clinical Center and will stay for 4 weeks without leaving. They can have visitors. Participants will wear activity and glucose monitors throughout the study. They will be weighed daily and will complete daily exercise. They will eat 3 meals daily, plus snacks. They will give urine, saliva, and blood samples. They will fill out questionnaires and rate their hunger, appetite, and sense of taste. They will have body scans. For the scans, they will lie in a machine that takes X-ray pictures of the body. Participants will complete activities to measure how many calories they burn and how the diets affect them: Participants will drink special liquids to measure calories burned, sugar, and sense of taste. Participants will wear a plastic hood while resting. Participants will stay alone in a special room for 24 hours. Participants will eat a low-carb, high-fat diet for 2 weeks and a high-carb, low-fat diet for 2 weeks. Participants may be dismissed if they purposefully use the study to try to change their body weight. Sponsoring Institution: National Institute of Diabetes and Digestive and Kidney Diseases ...

Detailed description

Competing theories about obesity and its treatment contrast the relative roles of dietary fat versus carbohydrate on promotion of excessive calorie intake. Advocates of low-carbohydrate diets propose that diets high in carbohydrates lead to elevated insulin secretion and increased calorie intake. Alternatively, proponents of low-fat diets argue that diets high in fat promote passive overconsumption due to the high energy density and low satiety index of high-fat foods. Therefore, we will conduct a feeding study in 20 adult men and women to investigate the differences in ad libitum energy intake resulting from consuming two test diets for a pair of 2-week periods in a randomized, crossover design during a single 4-week inpatient period. The test diets presented to participants will be matched for calories and protein, but the low-carbohydrate diet (approximately10% of calories) will be high in fat (approximately75% of calories) whereas the low-fat diet will be high in carbohydrates (approximately75% of calories) and low in fat (approximately 10% of calories).

Interventions

DIETARY_SUPPLEMENTLCHF diet

low-carbohydrate, high-fat (LCHF)diet

DIETARY_SUPPLEMENTLFHC diet

low-fat, high-carbohydrate (LFHC) diet

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* INCLUSION CRITERIA: 1. Adults age 18-50 years, male and female 2. Weight stable (less than or equal to 5 % over past 6 months) as determined by volunteer report 3. Body mass index (BMI) greater that or equal to 20kg/m2 4. Body weight greater than or equal to 53 kg 5. Able to complete daily bouts of stationary cycling at a moderate rate and intensity with a heart rate (HR) equal to or greater than 0.3(SqrRoot) (220-age-HRrest)+HRrest but not exceeding 0.4(SqrRoot) (220-age-HRrest)+HRrest and no signs of arrhythmia

Exclusion criteria

1. Evidence of metabolic or cardiovascular disease, or disease that may influence metabolism (e.g. cancer, diabetes, thyroid disease) 2. Taking any prescription medication or other drug that may influence metabolism (e.g. diet/weight-loss medication, asthma medication, blood pressure medication, psychiatric medications, corticosteroids, or other medications at the discretion of the PI and/or study team) 3. Positive pregnancy test or lactation as determined by volunteer report (women only) 4. Participating in a regular exercise program (\> 2h/week of vigorous activity) as determined by volunteer report 5. Hematocrit \<37% (women only) 6. Hematocrit \< 40% (men only) 7. Caffeine consumption \> 300 mg/day as determined by volunteer report 8. Regular use of alcohol (\> 2 drinks per day), tobacco (smoking or chewing) amphetamines, cocaine, heroin, or marijuana over past 6 months as determined by volunteer report 9. Psychological conditions such as (but not limited to) eating disorders, claustrophobia, clinical depression, bipolar disorders, that would be incompatible with safe and successful participation in this study, as determined by investigators. 1. Past or present history of eating disorders as determined by volunteer report 2. Past or present history of claustrophobia since part of the protocol will involve being confined to a small room for whole-body indirect calorimetry and being in an MRI scanner for liver fat measures 10. Implants, devices, or foreign objects implanted in the body that interfere with the Magnetic Resonance procedures 11. Volunteers with strict dietary concerns (e.g. vegetarian or kosher diet, food allergies) 12. Volunteers unwilling or unable to give informed consent 13. Non-English speakers due to unavailability of required questionnaires in other languages

Design outcomes

Primary

MeasureTime frameDescription
Ad Libitum Energy Intake14 daysAd libitum energy intake averaged over 14 days for each diet, measured in kilocalories (kcal) per day.

Secondary

MeasureTime frameDescription
Change in Body WeightBaseline and day 14Change in body weight from baseline to day 14 for each diet, measured in kilograms (kg)
Change in Body Fat MassBaseline and day 14Change in body fat mass from baseline to day 14 for each diet, measured in kilograms (kg). Body fat mass was measured using Dual-energy X-ray absorptiometry (DXA) measurements.
Change in CholesterolBaseline and day 14Change in cholesterol from baseline to day 14 for each diet
Mean Glucose During Oral Glucose Tolerance Test (OGTT)Day 14An OGTT was performed at the end of each 14 day period and the mean glucose was calculated
Change in TSHBaseline and day 14Change in thyroid stimulating hormone (TSH) from baseline to day 14 for each diet
Change in C-peptideBaseline and day 14Change in C-peptide from baseline to day 14 for each diet
Change in CRPBaseline and day 14Change in C-reactive protein (CRP) from baseline to day 14 for each diet
Change in TriglyceridesBaseline and day 14Change in triglycerides from baseline to day 14 for each diet

Countries

United States

Participant flow

Participants by arm

ArmCount
LCHF Diet Then LFHC Diet
Low carbohydrate, high fat (LCHF) diet then low fat, high carbohydrate diet (LFHC) diet
11
LFHC Diet Then LCHF Diet
Low fat, high carbohydrate diet (LFHC) diet then low carbohydrate, high fat (LCHF) diet
10
Total21

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyAdverse Event10

Baseline characteristics

CharacteristicLCHF Diet Then LFHC DietTotalLFHC Diet Then LCHF Diet
Age, Continuous28.7 Years
STANDARD_DEVIATION 7.1
30.1 Years
STANDARD_DEVIATION 6.4
31.6 Years
STANDARD_DEVIATION 5.5
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants4 Participants2 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
9 Participants17 Participants8 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
1 Participants2 Participants1 Participants
Race (NIH/OMB)
Black or African American
4 Participants8 Participants4 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants1 Participants0 Participants
Race (NIH/OMB)
White
5 Participants10 Participants5 Participants
Region of Enrollment
United States
11 participants21 participants10 participants
Sex: Female, Male
Female
5 Participants9 Participants4 Participants
Sex: Female, Male
Male
6 Participants12 Participants6 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 210 / 20
other
Total, other adverse events
1 / 210 / 20
serious
Total, serious adverse events
0 / 210 / 20

Outcome results

Primary

Ad Libitum Energy Intake

Ad libitum energy intake averaged over 14 days for each diet, measured in kilocalories (kcal) per day.

Time frame: 14 days

ArmMeasureValue (MEAN)Dispersion
LC DietAd Libitum Energy Intake2752 kcal per dayStandard Error 52
LF DietAd Libitum Energy Intake2063 kcal per dayStandard Error 52
Secondary

Change in Body Fat Mass

Change in body fat mass from baseline to day 14 for each diet, measured in kilograms (kg). Body fat mass was measured using Dual-energy X-ray absorptiometry (DXA) measurements.

Time frame: Baseline and day 14

ArmMeasureValue (MEAN)Dispersion
LC DietChange in Body Fat Mass-0.18 kgStandard Error 0.19
LF DietChange in Body Fat Mass-0.67 kgStandard Error 0.19
Secondary

Change in Body Weight

Change in body weight from baseline to day 14 for each diet, measured in kilograms (kg)

Time frame: Baseline and day 14

ArmMeasureValue (MEAN)Dispersion
LC DietChange in Body Weight1.77 kgStandard Error 0.32
LF DietChange in Body Weight1.09 kgStandard Error 0.32
Secondary

Change in Cholesterol

Change in cholesterol from baseline to day 14 for each diet

Time frame: Baseline and day 14

ArmMeasureValue (MEAN)Dispersion
LC DietChange in Cholesterol-1.25 mg/dlStandard Error 5.47
LF DietChange in Cholesterol-41.75 mg/dlStandard Error 5.47
Secondary

Change in C-peptide

Change in C-peptide from baseline to day 14 for each diet

Time frame: Baseline and day 14

ArmMeasureValue (MEAN)Dispersion
LC DietChange in C-peptide-0.610 ng/mlStandard Error 0.08
LF DietChange in C-peptide-0.250 ng/mlStandard Error 0.08
Secondary

Change in CRP

Change in C-reactive protein (CRP) from baseline to day 14 for each diet

Time frame: Baseline and day 14

ArmMeasureValue (MEAN)Dispersion
LC DietChange in CRP0.068 mg/lStandard Error 0.289
LF DietChange in CRP-0.842 mg/lStandard Error 0.296
Secondary

Change in Triglycerides

Change in triglycerides from baseline to day 14 for each diet

Time frame: Baseline and day 14

ArmMeasureValue (MEAN)Dispersion
LC DietChange in Triglycerides-12.1 mg/dlStandard Error 6.4
LF DietChange in Triglycerides17.9 mg/dlStandard Error 6.4
Secondary

Change in TSH

Change in thyroid stimulating hormone (TSH) from baseline to day 14 for each diet

Time frame: Baseline and day 14

ArmMeasureValue (MEAN)Dispersion
LC DietChange in TSH0.082 uIU/mlStandard Error 0.176
LF DietChange in TSH-0.403 uIU/mlStandard Error 0.176
Secondary

Mean Glucose During Oral Glucose Tolerance Test (OGTT)

An OGTT was performed at the end of each 14 day period and the mean glucose was calculated

Time frame: Day 14

ArmMeasureValue (MEAN)Dispersion
LC DietMean Glucose During Oral Glucose Tolerance Test (OGTT)115.6 mg/dlStandard Error 2.9
LF DietMean Glucose During Oral Glucose Tolerance Test (OGTT)143.3 mg/dlStandard Error 2.9

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026