Effect of Isocaloric Ultra Processed Versus Unprocessed Diets on Insulin Sensitivity
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03189121|
Recruitment Status : Recruiting
First Posted : June 16, 2017
Last Update Posted : March 29, 2018
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.
To learn about how a processed versus unprocessed diet affects the body.
Men ages 18-50 with stable weight and risk factors for diabetes
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
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Effect of Isocaloric Ultra Processed Versus Unprocessed Diets on Insulin Sensitivity|
|Actual Study Start Date :||November 20, 2017|
|Estimated Primary Completion Date :||February 28, 2019|
|Estimated Study Completion Date :||February 28, 2020|
20 overweight and obese adult men
- To determine changes in hepatic insulin sensitivity following a 3-week ultra-processed diet as compared to following 3 weeks of an unprocessed diet matched for calories, macronutrient composition, sugar, fiber, and sodium. [ Time Frame: ongoing ]
- To determine changes in hepatic triglyceride content following a 3-week ultra-processed diet as compared to 3 weeks of an unprocessed diet matched for calories, macronutrient composition, sugar, fiber, and sodium [ Time Frame: ongoing ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03189121
|Contact: Kevin Hall, Ph.D.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Kevin Hall, Ph.D.||National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|