Effect of Ultra-processed Versus Unprocessed Diets on Energy Metabolism (NCT05290064) | Clinical Trial Compass
CompletedNot Applicable
Effect of Ultra-processed Versus Unprocessed Diets on Energy Metabolism
United States66 participantsStarted 2022-11-04
Plain-language summary
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
...
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* 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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Energy Metabolism (kcal per day)
Timeframe: Four 1-week diets
Trial details
NCT IDNCT05290064
SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)