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NCT05290064 · ClinicalTrials.gov registry record · NA
Effect of Ultra-processed Versus Unprocessed Diets on Energy Metabolism
A NA study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- NA
- Development phase
- 66
- Enrollment target
NCT05290064: Completed NA study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
NCT05290064 is a NA study that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 66 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05290064, a NA study, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- NA
- Development phase
- 66 participants
- Enrollment target
Study Summary
Protocol Number: 22DK0002 Title: Effects of Ultra-processed versus Unprocessed Diets on Energy Metabolism Background: Many diets worldwide include both processed and unprocessed foods. Researchers want to study the effects these foods have on a person s health. Objective: To study how different diets affect a person s health and metabolism. Eligibility: Adults aged 18 60 without diabetes who have stable weight and can exercise. Design: Participants will be screened with: Medical history Physical exam Heart tests Resting energy expenditure (to determine calorie needs) Blood and urine tests 20-minute stationary bicycle session Food, diet, and mental health questionnaires Participants will stay at NIH for 4 weeks. They will receive 3 meals a day and may eat as little or as much as they want. The diet will change each week. Their weight will be recorded daily. They will ride a stationary bicycle daily. Each week, they will do the following: Spend 1 day in a special room that assesses their metabolism Have 24-hour urine collections Give skin and fecal samples Repeat some screening tests Have scans to measure body fat Complete computerized behavior tasks Wear an activity monitor to track physical activity Wear a glucose monitor. A sensor will be inserted under the skin with a small needle. It will be replaced weekly. Take taste tests. They will swish water and flavored liquids around in their mouth and pick which ones had a non-neutral taste. They will also compare liquids for which ones taste better. Participation will last for 4 weeks. Sponsoring Institution: National Institute of Diabetes and Digestive and Kidney Diseases ...
Primary Outcome
Energy intake averaged over 7 days for each diet, measured in kilocalories (kcal) per day. Primary comparisons will be between UPF HH \& UPF HL, UPF HL \& UPF LL, UPF LL \& UNF LL, UPF HH \& UNF LL.
Interventions
- OTHER Ultra-processed food, high energy density
- OTHER Ultra-processed food, both low
- OTHER Ultra-processed food, both high
- OTHER Unprocessed food diet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2022-11-04 |
| Est. Completion | 2025-08-15 |
| Phase | NA |
What the finished NCT05290064 record still lists
NCT05290064 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 4 interventions - of which Ultra-processed food, high energy density is the first listed.
NCT05290064 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05290064 about?
NCT05290064 is a clinical study titled "Effect of Ultra-processed Versus Unprocessed Diets on Energy Metabolism". Protocol Number: 22DK0002 Title: Effects of Ultra-processed versus Unprocessed Diets on Energy Metabolism Background: Many diets worldwide include both processed and unprocessed foods. Researchers want to study the effects these foods have on a person s health. Objective: To study how different...
What is the current status of trial NCT05290064?
This trial is currently completed. It is a NA study. The enrollment target is 66 participants. The study started on 2022-11-04. Estimated completion is 2025-08-15.
What interventions are being tested in trial NCT05290064?
The interventions under investigation include: Ultra-processed food, high energy density (OTHER), Ultra-processed food, both low (OTHER), Ultra-processed food, both high (OTHER), Unprocessed food diet (OTHER).
Who is sponsoring clinical trial NCT05290064?
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 NCT05290064's enrollment target sits among peer trials
66 1139th of 2000 higher than 857 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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