ENSATI protocol: time-restricted eating versus calorie restriction in adults with overweight/obesity and early fatty liver
The ENSATI protocol plans a six-month randomized trial in 177 adults aged 50-70 with overweight/obesity and incipient fatty liver disease, comparing time-restricted eating, 25% calorie restriction and active dietary counseling, followed by six months of monitoring. [1]
Automatic summary · not editorially reviewed
The key findings
ENSATI is planned as a randomized, open-label, controlled trial with three parallel arms: active dietary counseling control, 25% calorie restriction, and time-restricted eating with a 14-hour fasting/10-hour eating window, over six months plus six months of monitoring. [1]
Planned primary outcomes are changes in body composition, hepatic fat and metabolism; secondary outcomes include glucose regulation, gut microbiome, molecular biomarkers of aging, and psychological, cognitive, sleep and dietary assessments. [1]
The protocol states that prior time-restricted eating and calorie restriction studies were limited by short durations, small samples and poor control of energy intake, and often lacked molecular biomarkers of aging. [1]
The source at a glance
- Study type / format
- Protocol for a randomized, open-label, controlled trial with three parallel arms
- Population / context
- Planned enrollment of 177 adults aged 50-70 years with overweight/obesity and incipient fatty liver disease.
- Summary based on
- Study abstract
- Original publication
- June 12, 2026
Planned three-arm diet trial in adults 50-70
This is a protocol, not results. The ENSATI trial is described as a randomized, open-label, controlled study with three parallel arms: active dietary counseling as control, 25% calorie restriction, and time-restricted eating with a 14-hour fasting/10-hour eating window. It is planned to run six months, followed by six months of post-intervention monitoring. A total of 177 adults aged 50-70 years with overweight/obesity and incipient fatty liver disease are to be enrolled.
Supporting source [1]
Planned outcomes: body composition, liver fat, aging markers
Primary outcomes are planned as changes in body composition measured by dual X-ray densitometry, hepatic fat measured by elastography, and metabolism measured by indirect calorimetry. Secondary outcomes are to include glucose regulation via continuous glucose monitoring, gut microbiome profiles, and molecular biomarkers of aging covering epigenetics, autophagy and immunosenescence, alongside psychological, cognitive, sleep and dietary assessments using validated tools. Analyses are planned as intention-to-treat, with per-protocol sensitivity analyses and sex-stratified models, using mixed-effects models adjusted for potential confounders.
Supporting source [1]
Protocol rationale and stated limits of prior studies
The protocol states that current time-restricted eating and calorie restriction studies are limited by short durations, small samples and poor control of energy intake, and often lack molecular biomarkers of aging. ENSATI is presented as addressing these gaps through a 12-month, adequately powered, randomized, multi-arm design with rigorous dietary monitoring and comprehensive molecular and physiological profiling. The stated aim is to explore the relative contributions of caloric intake versus chronobiological effects on obesity and aging. The study was approved by the IMDEA Ethics Committee (IMF PI-057), and all participants are to provide written informed consent.
Supporting source [1]
How to interpret this
This is an abstract of a study protocol; no results are reported. The full text was not reviewed. Planned sample, outcomes and analyses are described, but whether the trial was completed or what it found is not stated.
Based on the study abstract; the full paper, tables and supplementary data were not reviewed.
Source & supporting passages
Celada-Guerrero JA, Rubio-Gordón L, Jiménez-Perez Y, López-Lora L, López-González A, Delbuono S, Huertas A, Martínez-Urbistondo D, Ordovás JM, de la O V, Daimiel L. · europepmc.org · June 12, 2026