HealthyNCT03878108
Effects of Low Fat Versus Low Carbohydrate Diets on Energy Metabolism
A study testing LCHF diet and LFHC diet in people with Healthy and Healthy Volunteers, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Healthy Volunteers
- What is being tested?
- LCHF diet and LFHC diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2019to 1 Sep 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults age 18-50 years, male and female
- Weight stable (less than or equal to 5 % over past 6 months) as determined by volunteer report
- Body mass index (BMI) greater that or equal to 20kg/m2
- Body weight greater than or equal to 53 kg
- 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
Who cannot join
- Evidence of metabolic or cardiovascular disease, or disease that may influence metabolism (e.g. cancer, diabetes, thyroid disease)
- 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)
- Positive pregnancy test or lactation as determined by volunteer report (women only)
- Participating in a regular exercise program (> 2h/week of vigorous activity) as determined by volunteer report
- Hematocrit <37% (women only)
- Hematocrit < 40% (men only)
Show all 15Show fewer
- Caffeine consumption > 300 mg/day as determined by volunteer report
- 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
- 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.
- Past or present history of eating disorders as determined by volunteer report
- 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
- Implants, devices, or foreign objects implanted in the body that interfere with the Magnetic Resonance procedures
- Volunteers with strict dietary concerns (e.g. vegetarian or kosher diet, food allergies)
- Volunteers unwilling or unable to give informed consent
- Non-English speakers due to unavailability of required questionnaires in other languages
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Effect of Low Fat Versus Low Carbohydrate Diets on Energy Metabolism
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.
Read more
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
...
Read the 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).
- Conditions
- Healthy, Healthy Volunteers
- Being tested
- LCHF diet, LFHC diet
- Keywords
- Accelerometry, Body Composition, Body Weight Regulation, Calories, Energy Expenditure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LCHF dietDietary supplement
low-carbohydrate, high-fat (LCHF)diet
LFHC dietDietary supplement
low-fat, high-carbohydrate (LFHC) diet
| Study group | Role | What they receive |
|---|---|---|
| LCHF diet then LFHC diet | Active comparator | Low carbohydrate, high fat (LCHF) diet then low fat, high carbohydrate diet (LFHC) diet Receives: Dietary Supplement: LCHF diet; Dietary Supplement: LFHC diet |
| LFHC diet then LCHF diet | Active comparator | Low fat, high carbohydrate diet (LFHC) diet then low carbohydrate, high fat (LCHF) diet Receives: Dietary Supplement: LCHF diet; Dietary Supplement: LFHC diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ad Libitum Energy Intake
Ad libitum energy intake averaged over 14 days for each diet, measured in kilocalories (kcal) per day.
Measured: 14 days
Secondary outcomes (8)
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
Measured: Day 14
Change in Body Weight
Change in body weight from baseline to day 14 for each diet, measured in kilograms (kg)
Measured: Baseline and day 14
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.
Measured: Baseline and day 14
Change in Cholesterol
Change in cholesterol from baseline to day 14 for each diet
Measured: Baseline and day 14
Change in Triglycerides
Change in triglycerides from baseline to day 14 for each diet
Measured: Baseline and day 14
Change in TSH
Change in thyroid stimulating hormone (TSH) from baseline to day 14 for each diet
Measured: Baseline and day 14
Change in C-peptide
Change in C-peptide from baseline to day 14 for each diet
Measured: Baseline and day 14
Change in CRP
Change in C-reactive protein (CRP) from baseline to day 14 for each diet
Measured: Baseline and day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start15 Apr 2019
- Primary completion4 Mar 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Kevin Hall, Ph.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03878108
- Sponsor's protocol ID
- 190067
- Other IDs
- 19-DK-0067
- Status last verified
- 4 Dec 2020
- First submitted
- 15 Mar 2019
- Last updated
- 3 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jaime-Lara RB, Franks AT, Nawal N, Steck MC, Chao AM, Allen C, Brooks BE, Atkinson M, Courville AB, Guo J, Yang S, Marzouk M, Darcey VL, Chung S, Forde CG, Hall KD, Joseph PV. The Role of Diet and Hormones on Taste: Low Carb Compared With Low Fat Study Findings. Curr Dev Nutr. 2025 May 19;9(6):107467. doi: 10.1016/j.cdnut.2025.107467. eCollection 2025 Jun.
PubMed 40606290Hengist A, Ong JA, McNeel K, Guo J, Hall KD. Imprecision nutrition? Intraindividual variability of glucose responses to duplicate presented meals in adults without diabetes. Am J Clin Nutr. 2025 Jan;121(1):74-82. doi: 10.1016/j.ajcnut.2024.10.007. Epub 2024 Dec 2.
PubMed 39755436Sciarrillo CM, Guo J, Hengist A, Darcey VL, Hall KD. Diet order significantly affects energy balance for diets varying in macronutrients but not ultraprocessing in crossover studies without a washout period. Am J Clin Nutr. 2024 Oct;120(4):953-963. doi: 10.1016/j.ajcnut.2024.08.013. Epub 2024 Aug 18.
PubMed 39163976Link VM, Subramanian P, Cheung F, Han KL, Stacy A, Chi L, Sellers BA, Koroleva G, Courville AB, Mistry S, Burns A, Apps R, Hall KD, Belkaid Y. Differential peripheral immune signatures elicited by vegan versus ketogenic diets in humans. Nat Med. 2024 Feb;30(2):560-572. doi: 10.1038/s41591-023-02761-2. Epub 2024 Jan 30.
PubMed 38291301Sciarrillo CM, Guo J, Hengist A, Darcey VL, Hall KD. Diet order affects energy balance in randomized crossover feeding studies that vary in macronutrients but not ultra-processing. medRxiv [Preprint]. 2023 Oct 4:2023.10.03.23296501. doi: 10.1101/2023.10.03.23296501.
PubMed 37986904O'Connor LE, Hall KD, Herrick KA, Reedy J, Chung ST, Stagliano M, Courville AB, Sinha R, Freedman ND, Hong HG, Albert PS, Loftfield E. Metabolomic Profiling of an Ultraprocessed Dietary Pattern in a Domiciled Randomized Controlled Crossover Feeding Trial. J Nutr. 2023 Aug;153(8):2181-2192. doi: 10.1016/j.tjnut.2023.06.003. Epub 2023 Jun 3.
PubMed 37276937Hall KD, Guo J, Courville AB, Boring J, Brychta R, Chen KY, Darcey V, Forde CG, Gharib AM, Gallagher I, Howard R, Joseph PV, Milley L, Ouwerkerk R, Raisinger K, Rozga I, Schick A, Stagliano M, Torres S, Walter M, Walter P, Yang S, Chung ST. Effect of a plant-based, low-fat diet versus an animal-based, ketogenic diet on ad libitum energy intake. Nat Med. 2021 Feb;27(2):344-353. doi: 10.1038/s41591-020-01209-1. Epub 2021 Jan 21.
PubMed 33479499
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low Fat Versus Low Carbohydrate Diets on Energy Metabolism
- ClinicalTrials.gov ID
- NCT03878108
- Acronym / sponsor ID
- 190067
- Conditions
- Healthy, Healthy Volunteers
- Keywords
- Accelerometry, Body Composition, Body Weight Regulation, Calories, Energy Expenditure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 4 Mar 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 18 Mar 2019 (actual)
- Results
- Posted 3 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LCHF diet then LFHC diet | Active comparator | Dietary Supplement: LCHF diet, Dietary Supplement: LFHC dietLow carbohydrate, high fat (LCHF) diet then low fat, high carbohydrate diet (LFHC) diet |
| LFHC diet then LCHF diet | Active comparator | Dietary Supplement: LCHF diet, Dietary Supplement: LFHC dietLow fat, high carbohydrate diet (LFHC) diet then low carbohydrate, high fat (LCHF) diet |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
Key exclusion criteria (15 listed)
- Evidence of metabolic or cardiovascular disease, or disease that may influence metabolism (e.g. cancer, diabetes, thyroid disease)
- 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)
- Positive pregnancy test or lactation as determined by volunteer report (women only)
- Participating in a regular exercise program (> 2h/week of vigorous activity) as determined by volunteer report
- Hematocrit <37% (women only)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LCHF dietlow-carbohydrate, high-fat (LCHF)diet | Dietary supplement | LCHF diet then LFHC diet, LFHC diet then LCHF diet |
| LFHC dietlow-fat, high-carbohydrate (LFHC) diet | Dietary supplement | LCHF diet then LFHC diet, LFHC diet then LCHF diet |
Primary outcome
Ad Libitum Energy Intake
Time frame: 14 days
Ad libitum energy intake averaged over 14 days for each diet, measured in kilocalories (kcal) per day.
8 secondary outcomes
Mean Glucose During Oral Glucose Tolerance Test (OGTT)
Time frame: Day 14
Change in Body Weight
Time frame: Baseline and day 14
Change in Body Fat Mass
Time frame: Baseline and day 14
Change in Cholesterol
Time frame: Baseline and day 14
Change in Triglycerides
Time frame: Baseline and day 14
Change in TSH
Time frame: Baseline and day 14
Change in C-peptide
Time frame: Baseline and day 14
Change in CRP
Time frame: Baseline and day 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40606290Jaime-Lara RB, Franks AT, Nawal N, Steck MC, Chao AM, Allen C, Brooks BE, Atkinson M, Courville AB, Guo J, Yang S, Marzouk M, Darcey VL, Chung S, Forde CG, Hall KD, Joseph PV. The Role of Diet and Hormones on Taste: Low Carb Compared With Low Fat Study Findings. Curr Dev Nutr. 2025 May 19;9(6):107467. doi: 10.1016/j.cdnut.2025.107467. eCollection 2025 Jun.
- Derived from this study: PubMed 39755436Hengist A, Ong JA, McNeel K, Guo J, Hall KD. Imprecision nutrition? Intraindividual variability of glucose responses to duplicate presented meals in adults without diabetes. Am J Clin Nutr. 2025 Jan;121(1):74-82. doi: 10.1016/j.ajcnut.2024.10.007. Epub 2024 Dec 2.
- Derived from this study: PubMed 39163976Sciarrillo CM, Guo J, Hengist A, Darcey VL, Hall KD. Diet order significantly affects energy balance for diets varying in macronutrients but not ultraprocessing in crossover studies without a washout period. Am J Clin Nutr. 2024 Oct;120(4):953-963. doi: 10.1016/j.ajcnut.2024.08.013. Epub 2024 Aug 18.
- Derived from this study: PubMed 38291301Link VM, Subramanian P, Cheung F, Han KL, Stacy A, Chi L, Sellers BA, Koroleva G, Courville AB, Mistry S, Burns A, Apps R, Hall KD, Belkaid Y. Differential peripheral immune signatures elicited by vegan versus ketogenic diets in humans. Nat Med. 2024 Feb;30(2):560-572. doi: 10.1038/s41591-023-02761-2. Epub 2024 Jan 30.
- Derived from this study: PubMed 37986904Sciarrillo CM, Guo J, Hengist A, Darcey VL, Hall KD. Diet order affects energy balance in randomized crossover feeding studies that vary in macronutrients but not ultra-processing. medRxiv [Preprint]. 2023 Oct 4:2023.10.03.23296501. doi: 10.1101/2023.10.03.23296501.
- Derived from this study: PubMed 37276937O'Connor LE, Hall KD, Herrick KA, Reedy J, Chung ST, Stagliano M, Courville AB, Sinha R, Freedman ND, Hong HG, Albert PS, Loftfield E. Metabolomic Profiling of an Ultraprocessed Dietary Pattern in a Domiciled Randomized Controlled Crossover Feeding Trial. J Nutr. 2023 Aug;153(8):2181-2192. doi: 10.1016/j.tjnut.2023.06.003. Epub 2023 Jun 3.
- Derived from this study: PubMed 33479499Hall KD, Guo J, Courville AB, Boring J, Brychta R, Chen KY, Darcey V, Forde CG, Gharib AM, Gallagher I, Howard R, Joseph PV, Milley L, Ouwerkerk R, Raisinger K, Rozga I, Schick A, Stagliano M, Torres S, Walter M, Walter P, Yang S, Chung ST. Effect of a plant-based, low-fat diet versus an animal-based, ketogenic diet on ad libitum energy intake. Nat Med. 2021 Feb;27(2):344-353. doi: 10.1038/s41591-020-01209-1. Epub 2021 Jan 21.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin Hall, Ph.D. principal investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LCHF diet and LFHC diet in people with Healthy and Healthy Volunteers, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ad Libitum Energy Intake (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03878108, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2021.