Overweight study: Low-carbohydrate Diet vs Low-fat Diet
Official title Diet Order Effects of Low Fat vs. Low Carb Diets on Body Fat Change
ClinicalTrials.gov ID: NCT06325722
What this study is testing
- What it's testing
- The study wants to see how the order of a low‑fat and a low‑carbohydrate diet affects body‑fat change over eight weeks.
- Who it's for
- Adults ages 19‑50 with a body‑mass index of 25 or higher.
- What's involved
- You will eat only the meals delivered to your home, first one diet for four weeks, then the other for four weeks. You’ll weigh yourself daily, wear an activity monitor, use a glucose sensor, and test a finger‑prick blood drop for ketones. You’ll also give stool, blood and urine samples and attend three visits to the NIH for tests and scans.
- Time commitment
- The study lasts eight weeks with three required NIH visits and weekly virtual group meetings.
- Time commitment: about 2 weeks
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50
You may be able to join if
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Adults aged 18-50 years
- Weight stable (\< +/- 5% over past 6 months) as determined by volunteer report
- Body mass index (BMI) \>= 25 kg/m\^2
- Agreement to adhere to Lifestyle Considerations throughout the study duration
You likely can't join if
- people with cardiac pacemakers or other implants that may be affected by or affect the DXA measurements
- Inadequate access to equipment required for the study (e.g., too little refrigerator storage space or a microwave oven that is too small) as...
- Evidence of diseases or conditions that may influence appetite (e.g., cancer, diabetes, alterations of smell or taste post COVID-19), diseases or...
- Taking prescription medications or other drugs that may influence metabolism (including but not limited to diet/weight-loss medication, some...
- People unlikely to adhere to a relatively consistent daily and weekly routine and avoid travel during their participation in the study.
- People unlikely to abstain from off study food or supplements that may impact metabolism or appetite at the discretion of the study team
See the full eligibility criteria
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Adults aged 18-50 years
- Weight stable (\< +/- 5% over past 6 months) as determined by volunteer report
- Body mass index (BMI) \>= 25 kg/m\^2
- Agreement to adhere to Lifestyle Considerations throughout the study duration
- people with cardiac pacemakers or other implants that may be affected by or affect the DXA measurements
- 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
- 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...
- 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...
- People unlikely to adhere to a relatively consistent daily and weekly routine and avoid travel during their participation in the study.
- People unlikely to abstain from off study food or supplements that may impact metabolism or appetite at the discretion of the study team
- Positive pregnancy test or lactating as determined by volunteer report (women only)
- Inability or unwillingness to use birth control between screening and completion of the study (women only)
- Symptoms or signs of perimenopause or menopause by volunteer report (women only)
- Regular vigorous exercise \>150 min per week as determined by volunteer report
- Alcohol consumption \> 3 drinks per day as determined by volunteer report
- Regular use of tobacco (smoking, chewing, or vaping), nicotine replacement therapy, or illicit drugs over past 6 months as determined by volunteer report. people may also be excluded based on a urine drug test.
- 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...
- 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
- Volunteers unwilling or unable to give informed consent
- Non-English speakers due to unavailability of required questionnaires in other languages
- Resting Energy Expenditure test result within 10% of the 2500 calorie requirement at rest
The study team makes the final eligibility decision.
Where it is enrolling
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 2 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Bethesda, Maryland, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.