NCT05290064Completed
Effect of Ultra-processed Versus Unprocessed Diets on Energy Metabolism
Source: ClinicalTrials.gov · Last updated 12 Aug 2026
Brief summary (registry, in English)
Protocol Number: 22DK0002 Title: Effects of Ultra-processed versus Unprocessed Diets on Energy Metabolism Background: Many diets worldwide include both processed and unprocessed foods. Researchers want to study the effects these foods have on a person s health. Objective: To study how different diets affect a person s health and metabolism. Eligibility: Adults aged 18 60 without diabetes who have stable weight and can exercise. Design: Participants will be screened with: Medical history Physical exam Heart tests Resting energy expenditure (to determine calorie needs) Blood and urine tests 20-minute stationary bicycle session Food, diet, and mental health questionnaires Participants will stay at NIH for 4 weeks. They will receive 3 meals a day and may eat as little or as much as they want. The diet will change each week. Their weight will be recorded daily. They will ride a stationary bicycle daily. Each week, they will do the following: Spend 1 day in a special room that assesses their metabolism Have 24-hour urine collections Give skin and fecal samples Repeat some screening tests Have scans to measure body fat Complete computerized behavior tasks Wear an activity monitor to track physical activity Wear a glucose monitor. A sensor will be inserted under the skin with a small needle. It will be replaced weekly. Take taste tests. They will swish water and flavored liquids around in their mouth and pick which ones had a non-neutral taste. They will also compare liquids for which ones taste better. Participation will last for 4 weeks. Sponsoring Institution: National Institute of Diabetes and Digestive and Kidney Diseases ...
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 38 (actual)
- First submitted
- 19 Mar 2022
- Start date
- 24 Nov 2022
- Primary completion date
- 15 Aug 2025
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Diseases
- Obesity
- NCT number
- NCT05290064
What you commit to
- Study type: Interventional
- Participants enrolled: 38
- From 24 Nov 2022 to the primary completion date, 15 Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
- 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.
Other illness
- 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).
- 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
Other
- An individual who meets any of the following criteria will be excluded from participation in this study:
- 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
- Volunteers unwilling or unable to give informed consent
Criteria the registry did not label
- 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.
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Institutes of Health Clinical Center Coordinator of this site? Confirm its status | Bethesda | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.