Effects of Low Fat Versus Low Carbohydrate Diets on Energy Metabolism

NCT03878108 | Completed Results

• 2 other identifiers: 19006719-DK-0067
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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 ...

Conditions

Healthy; Healthy Volunteers

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Ad Libitum Energy Intake

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

  14 days

Secondary Outcomes (8)

• Mean Glucose During Oral Glucose Tolerance Test (OGTT)

  Day 14

• Change in Body Weight

  Baseline and day 14

• Change in Body Fat Mass

  Baseline and day 14

• Change in Cholesterol

  Baseline and day 14

• Change in Triglycerides

  Baseline and day 14

Study Arms (2)

LCHF diet then LFHC diet

ACTIVE COMPARATOR

Low carbohydrate, high fat (LCHF) diet then low fat, high carbohydrate diet (LFHC) diet

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

Dietary Supplement: LCHF diet; Dietary Supplement: LFHC diet

Interventions

LCHF diet DIETARY_SUPPLEMENT

low-carbohydrate, high-fat (LCHF)diet

LCHF diet then LFHC diet; LFHC diet then LCHF diet

LFHC diet DIETARY_SUPPLEMENT

low-fat, high-carbohydrate (LFHC) diet

LCHF diet then LFHC diet; LFHC diet then LCHF diet

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (7)

• 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.

  PMID: 40606290 DERIVED

• Hengist 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.

  PMID: 39755436 DERIVED

• Sciarrillo 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.

  PMID: 39163976 DERIVED

• Link 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. Erratum In: Nat Med. 2024 Jun;30(6):1785. doi: 10.1038/s41591-024-02884-0.

  PMID: 38291301 DERIVED

• Sciarrillo 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.

  PMID: 37986904 DERIVED

• O'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.

  PMID: 37276937 DERIVED

• Hall 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.

  PMID: 33479499 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

Results Point of Contact

• Title: Kevin Hall, PhD
• Organization: NIDDK

kevin.hall@nih.gov

301-402-8248

Study Officials

• Kevin Hall, Ph.D.

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2019
• First Posted: March 18, 2019
• Study Start: April 15, 2019
• Primary Completion: March 4, 2020
• Study Completion: September 1, 2020
• Last Updated: June 3, 2021
• Results First Posted: June 3, 2021

Record last verified: 2020-12-04

Locations

US (1)