Status:
COMPLETED
Effect of Ultra-processed Versus Unprocessed Diets on Energy Metabolism
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Healthy Diet
Obesity
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief 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 ...
Detailed Description
This is a randomized crossover study of adult volunteers to determine the health effects of four different diets varying in non-beverage energy density, hyperpalatable foods, as well as the degree, ex...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 15 2025
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT05290064
Start Date
November 4 2022
End Date
August 15 2025
Last Update
August 28 2025
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892