Last reviewed · How we verify
NCT05880095: ENSATI
Healthy Aging Through Time- Restricted Eating in Adults With Overweight/Obesity and Incipient Liver Disease: ENSATI
NA trial testing Unrestricted Mediterranean diet in Biological Aging in 176 participants. Completed in 15 March 2026.
15 March 2026
Quick facts
| Lead sponsor | IMDEA Food |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | prevention |
| Enrollment | 176 |
| Start date | 5 July 2023 |
| Primary completion | 15 March 2026 |
| Estimated completion | 15 March 2026 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- Unrestricted Mediterranean diet
- Energy-reduced Mediterranean diet
- Mediterranean diet with time-restricted eating
Conditions studied
- Biological Aging — all drugs for Biological Aging →
Sponsor
IMDEA Food
Who can join
Adults 55 to 70, any sex, with Biological Aging. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this clinical trial is to evaluate the effect of a time-restricted eating (TRE) regimen on hallmarks of aging, in comparison with traditional caloric restriction and an unrestricted diet in adults with overweight/obesity. Investigators aim to assess: 1. If TRE is sustainable over 6-months. 2. If TRE positively affects metabolism and body composition 3. If TRE improves circadian rhythm/sleep. 4. If TRE benefits cognitive function, mood and quality of life (QoL). 5. If these beneficial effects are associated with changes in molecular hallmarks of aging. Participants will be randomly allocated to: * an unrestricted Mediterranean diet group (MedD) * a energy-reduced Mediterranean diet group (MedD\_RC) * or to an unrestricted Mediterranean diet with TRE group (MedD\_TRE) Intervention will be maintained for 6 months, and there will be an additional 6-months period of follow-up to assess the maintenance of the intervention without supervision. Changes from baseline in phenotypic and molecular hallmarks of aging, including: chronobiology, quality of life, cognition, metabolism and epigenetics among groups over the follow-up will be analyzed.
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 NCT05880095
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Biological Aging
Currently open trials in the same condition.
- NCT06555978 — Ageing BIOmarker Study in Singaporeans · active not recruiting
- NCT04224038 — The Inspire Bio-resource Research Platform for Healthy Aging INSPIRE Platform · recruiting
Other IMDEA Food trials
Trials by the same sponsor.
- NCT06857929 — "Improving Health and Reducing Chronic Disease Risk in Middle-Aged Adults Through Nutrition" · NA · recruiting
- NCT06888570 — Relationship Between Eating Patterns, Body Composition and the Detection of Fatty Liver in Children and Adolescents With · enrolling by invitation
- NCT07456267 — Plant miRNAs In Human Plasma After Broccoli Consumption · NA · completed
- NCT07496320 — Critical Food Ingredients on Immunocompetence to Prevent the Risk and Development of Obesity/Metabolic Syndrome · NA · completed
- NCT06392828 — EndoNAFLD: Relationship Between Fatty Liver Disease and Cardiovascular Diseases · completed
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 NCT05880095 (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 IMDEA Food
- Last refreshed: 27 March 2026
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/NCT05880095.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing