Comparing the effects of processed and unprocessed diets on metabolism
Effect of Ultra-processed Versus Unprocessed Diets on Energy Metabolism
This study is testing how eating ultra-processed foods compares to unprocessed foods affects metabolism and health in adults aged 18 to 60.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT05290064 on ClinicalTrials.gov |
What this trial studies
This study investigates how different diets, specifically ultra-processed versus unprocessed foods, impact energy metabolism and overall health in adults. Participants aged 18 to 60 will undergo a randomized crossover design, where they will follow four different diets over four weeks while staying at the NIH Clinical Center. Each week, they will receive three meals a day and engage in daily exercise, with their weight and metabolic responses closely monitored. The study aims to assess differences in health effects, eating rates, and meal palatability across the diets.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18-60 who have stable weight and can engage in moderate exercise.
Not a fit: Patients with diabetes or other conditions affecting appetite may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into dietary choices that promote better health and weight management.
How similar studies have performed: Previous studies have shown varying effects of diet on health, but this specific comparison of ultra-processed versus unprocessed diets is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
* INCLUSION CRITERIA: In order to be eligible to participate in this study, an individual must meet all of the following criteria: * Provision of signed and dated informed consent form * Adults age 18-60 years, male and female * Weight stable (\< +/- 5 % body weight change over past 6 months) as determined by volunteer report * Body mass index (BMI) \> =20 kg/m2 * Body weight \> = 53 kg * Able to complete daily bouts of stationary cycling at a moderate rate and intensity with a 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 * Willingness to comply with all study procedures and Lifestyle Considerations for the duration of the study per the discretion of the PI. EXCLUSION CRITERIA: An individual who meets any of the following criteria will be excluded from participation in this study: * Evidence of diseases or conditions that may influence appetite (e.g., cancer, diabetes, alterations of smell or taste post COVID-19), or other conditions at the discretion of the PI and/or study team). * Taking prescription medications or other drugs that may influence appetite (including, but not limited to, diet/weight-loss medication 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 * Alcohol consumption \> 3 drinks per day for men or \> 2 drinks per day for women as determined by volunteer report * Regular use of tobacco (smoking or chewing), amphetamines, cocaine, heroin, or marijuana over past 6 months as determined by volunteer report. Subjects may also be excluded based on a urine drug test. * Psychological conditions as determined by volunteer report 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 * 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
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Valerie L Darcey — National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study coordinator: Nan Zhai, C.R.N.P.
- Email: nan.zhai@nih.gov
- Phone: (301) 827-3324
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.