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

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study ID
NCT06325722
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Low-carbohydrate Diet — OTHER
    Consisting of 15 percent protein, 75 percent fat, and 10 percent carbohydrate
  • Low-fat Diet — OTHER
    Consisting of 15 percent protein, 10 percent fat, and 75 percent carbohydrate

Study Details

Background: In a previous study, participants were lived at the NIH and randomly received either a low-fat or a low-carbohydrate diet for 2 weeks and then switched to the other diet for 2 more weeks. Participants who received the low-carbohydrate diet first lost more body fat at the end of the study than those who received the low-fat diet first. Researchers want to see if they can repeat that result in a longer weight loss study when participants live at home. Objective: To test the effects of diet order in people receiving either a low-fat or low-carbohydrate diet first for 4 weeks and then immediately switched to the other diet for another 4 weeks. Eligibility: Adults aged 19 to 50 years with a body mass index of 25 or more. Design: Participants will complete the study at their homes, but there will be 3 required visits to the NIH. Participants will drink a special type of water 2 weeks before the baseline NIH visit and collect urine samples at home to measure how many calories they burn. Before the diets begin, participants will visit the NIH for baseline testing when they will have a metabolism test while relaxing in a bed with a plastic hood over their head to collect the air they breathe out. They will have scans to measure their bone density and how much muscle and body fat they have. They will give stool, blood, and urine samples. Participants will be asked to eat a specific diet for 4 weeks followed by a different diet for 4 weeks. All meals will be delivered to the participants' homes. They will eat only the foods delivered. Participants will weigh themselves daily. They will wear a monitor to track their physical activity and a sensor to measure their glucose levels. They will prick their finger each morning to test a drop of blood for ketones. Participants will meet virtually as a group with the study team weekly. Participants will have two more NIH visits towards the end of each diet period....

Key Dates

Start date
Aug 28, 2024
Status verified
Jun 2026
Primary completion
Nov 30, 2029
Completion
Nov 30, 2029

Study Design

Enrollment
42 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

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

Primary Outcome Measure

Change in total fat mass [ Time Frame: 8 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
Valerie Darcey
[email protected]
301-402-9689

Find similar trials in Bethesda, MD

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
National Institutes of Health Clinical Center· Bethesda, MD

Related Studies