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NCT05290064
Effect of Ultra-processed Versus Unprocessed Diets on Energy Metabolism
NA trial testing Ultra-processed food, high energy density in Healthy Diet in 66 participants. Completed in 15 August 2025.
15 August 2025
Quick facts
| Lead sponsor | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 66 |
| Start date | 4 November 2022 |
| Primary completion | 15 August 2025 |
| Estimated completion | 15 August 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Ultra-processed food, high energy density
- Ultra-processed food, both low
- Ultra-processed food, both high
- Unprocessed food diet
Conditions studied
- Healthy Diet — all drugs for Healthy Diet →
- Obesity — all drugs for Obesity →
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Who can join
Adults 18 to 60, any sex, with Healthy Diet or Obesity. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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 ...
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05290064
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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- NCT06698094 — Sustainable Office Intervention, Impact of a Sustainable Lifestyle on Diet, Physical Activity and Carbon Footprint · NA · active not recruiting
Other National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) trials
Trials by the same sponsor.
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- NCT07388537 — Evaluation of the Clinical Spectrum of Diabetes and Obesity in Youth and Adults · not yet recruiting
- NCT05713799 — Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity · Phase 2 · not yet recruiting
- NCT05722210 — Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant · not yet recruiting
- NCT07191561 — Hepatic Lipid Metabolism-Alcohol Use Disorder · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05290064 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Last refreshed: 28 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05290064.
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