Recruiting

Effects of Diet Order on Fat Mass Change in Low Carb vs. Low Fat Diets

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Study Aim

This study aims to investigate how the order of low carb and low fat diets affects changes in your total fat mass, measured using dual energy X-ray absorptiometry (DXA), over an 8-week period.

What is being tested

Low-carbohydrate Diet

+ Low-fat Diet

Other
Who is being recruted

Body Weight+7

+ Body Weight Changes

+ Nutrition Disorders

From 18 to 50 Years
See all eligibility criteria
How is the trial designed

Basic Science Study

Interventional
Study Start: August 2024
See protocol details

Summary

Principal SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study ContactNan Zhai, C.R.N.P.More contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 28, 2024

Actual date on which the first participant was enrolled.

This clinical trial aims to investigate how the order of following a low carbohydrate diet compared to a low-fat diet affects body fat and weight changes in adults who are overweight or obese. Participants will follow each diet for four weeks without a break in between. The study seeks to understand whether starting with one diet over the other causes any significant changes in total body fat and weight. The results could provide useful insights for dietary recommendations and weight management strategies for individuals struggling with obesity or overweight. In this study, participants will be randomly assigned to begin with either a low carbohydrate diet followed by a low-fat diet or the reverse order. Each diet will last for four weeks. The study will measure changes in total body fat using a special scan called dual-energy X-ray absorptiometry (DEXA) at the start and end of the eight weeks. Additionally, daily weight measurements will help assess the rate of weight change during the last two weeks of each diet. This design helps to understand the impact of diet sequencing on body weight and fat changes, contributing to better dietary planning for weight loss.

Official TitleDiet Order Effects of Low Fat vs. Low Carb Diets on Body Fat Change
NCT06325722
Principal SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study ContactNan Zhai, C.R.N.P.More contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

42 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Body WeightBody Weight ChangesNutrition DisordersNutritional and Metabolic DiseasesObesitySigns and SymptomsPathological Conditions, Signs and SymptomsWeight LossOvernutritionOverweight

Criteria

* INCLUSION CRITERIA: In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Stated willingness to comply with all study procedures and availability for the duration of the study 2. Adults aged 18-50 years 3. Weight stable (\< +/- 5 percent over past 6 months) as determined by volunteer report 4. Body mass index (BMI) \>= 25 kg/m\^2 5. Agreement to adhere to Lifestyle Considerations throughout the study duration EXCLUSION CRITERIA: 1. Subjects with cardiac pacemakers or other implants that may be affected by or affect the DXA measurements 2. Inadequate access to equipment required for the study (e.g., too little refrigerator storage space or a microwave oven that is too small) as determined by discretion of PI and/or study team 3. Evidence of diseases or conditions that may influence appetite (e.g., cancer, diabetes, alterations of smell or taste post COVID-19), diseases or conditions that affect the immune system, or other conditions at the discretion of the PI and/or study team 4. Taking prescription medications or other drugs that may influence metabolism (including but not limited to diet/weight-loss medication, some psychiatric medications, or other medications at the discretion of the PI and/or study team) 5. People unlikely to adhere to a relatively consistent daily and weekly routine and avoid travel during their participation in the study. For example, people with occupations such as pilots, flight attendants, or frequently travel for work or pleasure. 6. People unlikely to abstain from off study food or supplements that may impact metabolism or appetite at the discretion of the study team 7. Positive pregnancy test or lactating as determined by volunteer report (women only) 8. Inability or unwillingness to use birth control between screening and completion of the study (women only) 9. Symptoms or signs of perimenopause or menopause by volunteer report (women only) 10. Regular vigorous exercise \>150 min per week as determined by volunteer report 11. Alcohol consumption \> 3 drinks per day as determined by volunteer report 12. Regular use of tobacco (smoking, chewing, or vaping), nicotine replacement therapy, or illicit drugs over past 6 months as determined by volunteer report. Subjects may also be excluded based on a urine drug test. 13. Psychological conditions as determined by DSM-5 Self-rated Level 1 Cross-cutting Symptom Measure such as (but not limited to) eating disorders, depression, bipolar disorders, that would be incompatible with safe and successful participation in this study, as determined by investigators 14. Volunteers with strict dietary concerns (e.g. vegetarian or kosher diet, food allergies) or a reported dislike of a significant fraction of the study foods 15. Volunteers unwilling or unable to give informed consent 16. Non-English speakers due to unavailability of required questionnaires in other languages

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
A low-carbohydrate followed by low-fat diet, each lasting for 4 weeks in adults with overweight or obesity

Group II

Experimental
A low-fat followed by low-carbohydrate diet, each lasting for 4 weeks in adults with overweight or obesity

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

National Institutes of Health Clinical Center

Bethesda, United StatesOpen National Institutes of Health Clinical Center in Google Maps
Recruiting
One Study Center