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NCT03407053 · ClinicalTrials.gov registry record · NA
Effect of Ultra Processed Versus Unprocessed Diets on Energy Intake
A NA study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
NCT03407053 is a NA study that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 20 participants.
The verdict
NCT03407053, a NA study, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
Study 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 for 4 weeks and do specialized tests of the effects. Participants will get two diets. They will have the same calories and nutrients, but one diet will be unprocessed food and the other will be ultra-processed. Objective: To better understand how processed and unprocessed foods affect daily food consumption and how the body handles blood sugar. Eligibility: Healthy adults ages 18-50 who have stable weight and can exercise Design: Participants will not eat for 12 hours. Then they will be screened with: * Medical history * Physical exam * Heart and blood tests * Resting energy expenditure test (REE). A hood will collect air exhaled while lying down for 30-40 minutes. * Psychiatric questions * Questions about mood, eating, sleep, and socioeconomic status * 20-minute stationary biking Female participants will have a urine pregnancy test. Participants will stay in the clinic for 4 weeks. For 2 weeks they will get a processed diet. For the other 2 weeks they will get an unprocessed diet. Participants cannot use the study period to gain or lose weight. Participants will have: * Meals and snacks provided * Daily exercise * Blood, urine, and saliva tests * To drink a special water and a very sweet liquid * REE * Scans and X-rays * To wear activity monitors and a device to measure blood sugar * Several 24-hour periods in a room that measures oxygen and carbon dioxide * Repeats of screening questions * Questions about hunger and meals * Sleep monitoring * Taste tests
Interventions
- DIETARY_SUPPLEMENT Ultra-processed diet
- DIETARY_SUPPLEMENT Unprocessed diet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2018-03-01 |
| Est. Completion | 2020-02-26 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03407053
The ClinicalTrials.gov registry entry for NCT03407053 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Ultra-processed diet is the first listed.
NCT03407053 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03407053 about?
NCT03407053 is a clinical study titled "Effect of Ultra Processed Versus Unprocessed Diets on Energy Intake". 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 for 4 weeks and do specialized tests of the effects. Participants will get two diets. They will have ...
What is the current status of trial NCT03407053?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2018-03-01. Estimated completion is 2020-02-26.
What interventions are being tested in trial NCT03407053?
The interventions under investigation include: Ultra-processed diet (DIETARY_SUPPLEMENT), Unprocessed diet (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT03407053?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
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