Effect of Isocaloric Ultra Processed Versus Unprocessed Diets on Insulin Sensitivity
Public ClinicalTrials.gov record NCT03189121. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT03189121
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 5 participants
Conditions and interventions
Conditions
Interventions
Not listed
Eligibility (public fields only)
- Age range
- 18 Years to 50 Years
- Sex
- Male
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 19, 2017
- Primary completion
- Apr 4, 2019
- Completion
- Apr 4, 2019
- Last update posted
- Apr 9, 2019
2017 – 2019
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03189121, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 9, 2019 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03189121 live on ClinicalTrials.gov.