Effect of Isocaloric Ultra Processed Versus Unprocessed Diets on Insulin Sensitivity
Completed
Conditions studied: Obesity
In brief
Background: Increases in obesity, diabetes, and some metabolic disorders may be linked to how much processed foods people eat. Researchers want to learn more about how processed foods affect metabolic health. Objective: To learn about how a processed versus unprocessed diet affects the body. Eligibility: Men ages 18-50 with stable weight and risk factors for diabetes Design: Participants will be screened over 3 visits. Screening includes: * Medical history and physical exam * Heart and blood tests * Psychiatric questions * Questions about eating, sleeping, and economic status * Riding a stationary bike * Trying a sample meal Between screenings, participants will eat prepared meals. They will wear an accelerometer to measure physical activity. They will write down what foods they eat and monitor their weight. Participants will have two 4-week stays in the clinic. They will: * Eat a special diet * Have activity and weight monitored * Drink water and collect urine samples to measure how many calories they are burning * Have resting energy expenditure measured with a clear hood over the head * Have a scan to measure body fat and bone density using low-dose x-rays * Have a scan on a table that slides into a metal cylinder in a strong magnetic field. They will get earplugs for the loud noises. * Have an ultrasound test to measure blood vessels * Have insulin and glucose infused into an arm vein. Blood will be taken over 10 hours through a plastic tube in the wrist. This will happen 4 times. * Spend multiple 24-hour periods in a room that measures oxygen used and carbon dioxide produced. * Give blood, urine and stool samples * Answer questionnaires and do computer tasks
Key facts
- Study ID
- NCT03189121
- Run by
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- People needed
- 5
- Starts
- 2017-11-20
- Expected to finish
- 2019-04-05
- Last updated by the study team
- 2019-04-10
Who can join
Age: 18 and older, up to 50. Sex: male. Healthy volunteers: accepted.
You may not qualify if…
- Evidence of metabolic or cardiovascular disease, or disease that may influence metabolism (e.g. cancer, diabetes, thyroid disease)
- Body weight >400 lbs. (weight limit of magnetic resonance spectroscopy gantry)
- 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 < 40%
- 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
- Past or present history of eating disorder (including binge eating) or psychiatric disease, including 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.
Where it is running
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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