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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: Completed NA study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Ad libitum energy intake averaged over 14 days for each diet, measured in kilocalories (kcal) per day.
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 |
What the finished NCT03407053 record still lists
NCT03407053 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Ultra-processed diet is the first listed.
NCT03407053 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03407053's enrollment target sits among peer trials
20 1768th of 2000 higher than 140 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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