Status:
COMPLETED
Effect of Ultra Processed Versus Unprocessed Diets on Energy Intake
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Healthy Diet
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
Background: Eating too much processed food is believed to lead to obesity. But the effect of processed food on energy intake has not been carefully studied. Researchers want to study people s diets f...
Detailed Description
Overconsumption of foods that result from extensive industrial processing is believed to contribute to the development of obesity. Ultra-processed foods now represent most of the calories consumed in ...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Adults age 18-50 years, male and female
- Weight stable (\< +/- 5 % over past 6 months)
- 4\. Body mass index (BMI) greater than or equal to 18 kg/m\^2
- 5\. Willing to cease their habitual caffeine intake during the study, beginning one week prior to inpatient admission
- 6\. Written informed consent
- 7\. Willing to eat the food provided in the study
- 8\. Able to complete daily bouts of stationary cycling at a moderate rate and intensity with a heart rate (HR) equal to or greater than 0.3x(220-age-HR(rest))+HR(rest) but not exceeding 0.4x(220-age-HR(rest))+HR(rest) and no signs of arrhythmia
- EXCLUSION CRITERIA:
- Evidence of metabolic or cardiovascular disease, or disease that may influence metabolism (e.g. cancer, diabetes, thyroid disease)
- Taking any prescription medication or other drug that may influence metabolism (e.g. diet/weight-loss medication, asthma medication, blood pressure medication, psychiatric medications, corticosteroids, or other medications at the discretion of the PI and/or study team)
- Hematocrit \< 34% (women only)
- Hematocrit \< 40% (men only)
- Pregnancy, lactation (women only)
- Participating in a regular exercise program (\> 2h/week of vigorous activity)
- Caffeine consumption \> 300 mg/day
- Regular use of alcohol (\> 2 drinks per day), tobacco (smoking or chewing) amphetamines, cocaine, heroin, or marijuana over past 6 months
- Eating disorders or psychological conditions, such as (but not limited to) claustrophobia, clinical depression, bi-polar disorders, that would be incompatible with safe and successful participation in this study, as determined by investigators.
- -Past or present history of claustrophobia since part of the protocol will involve being confined to a small room for whole-body indirect calorimetry and being in an MRI scanner for liver fat measures
- Implants, devices, or foreign objects implanted in the body that interfere with the Magnetic Resonance procedures
- Volunteers with strict dietary concerns (e.g. vegetarian or kosher diet, food allergies)
- Volunteers unwilling or unable to give informed consent
- Non-English speakers due to unavailability of required questionnaires in other languages.
Exclusion
Key Trial Info
Start Date :
March 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 26 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03407053
Start Date
March 1 2018
End Date
February 26 2020
Last Update
June 29 2021
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892