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NCT06325722 · ClinicalTrials.gov registry record · NA
Diet Order Effects of Low Fat vs. Low Carb Diets on Body Fat Change
A NA study of Obesity and Overweight, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Recruiting
- Registry status
- NA
- Development phase
- 42
- Enrollment target
- 1
- Study location
NCT06325722: Recruiting NA study of Obesity and Overweight, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
NCT06325722 is a NA study of Obesity and Overweight that is actively recruiting participants, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 42 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06325722, a NA study of Obesity and Overweight, is actively recruiting participants, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- RECRUITING
- Registry status
- NA
- Development phase
- 42 participants
- Enrollment target
- 1
- Study location
Study Summary
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....
Primary Outcome
Change in total fat mass (kg) as measured by dual energy X-ray absorptiometry (DXA) from baseline to week 8
Conditions Studied
Interventions
- OTHER Low-carbohydrate Diet
- OTHER Low-fat Diet
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2024-08-28 |
| Est. Completion | 2026-07-31 |
| Phase | NA |
What NCT06325722 shows while recruiting
NCT06325722 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (95% lower).
The record links to 2 conditions, with Obesity appearing as the primary indexed condition, and to 2 interventions - of which Low-carbohydrate Diet is the first listed.
NCT06325722 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT06325722 about?
NCT06325722 is a clinical study titled "Diet Order Effects of Low Fat vs. Low Carb Diets on Body Fat Change". 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 stud...
What is the current status of trial NCT06325722?
This trial is currently recruiting. It is a NA study. The enrollment target is 42 participants. The study started on 2024-08-28. Estimated completion is 2026-07-31.
What conditions does trial NCT06325722 study?
This clinical trial studies the following conditions: Obesity, Overweight.
What interventions are being tested in trial NCT06325722?
The interventions under investigation include: Low-carbohydrate Diet (OTHER), Low-fat Diet (OTHER).
Who is sponsoring clinical trial NCT06325722?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06325722 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06325722's enrollment target sits among peer trials
42 771st of 1053 higher than 280 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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