Healthy Aging Through Time- Restricted Eating in Adults With Overweight/Obesity and Incipient Liver Disease: ENSATI
NCT05880095, Not applicable, Completed, IMDEA Food
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Healthy Aging Through Time- Restricted Eating in Adults With Overweight/Obesity and Incipient Liver Disease: ENSATI | ClinicalTrials.gov |
| NCT number | NCT05880095 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 176 participants, actual | ClinicalTrials.gov |
| Lead sponsor | IMDEA Food | ClinicalTrials.gov |
| Conditions | Biological Aging | ClinicalTrials.gov |
| Interventions | Unrestricted Mediterranean diet, Energy-reduced Mediterranean diet, Mediterranean diet with time-restricted eating | ClinicalTrials.gov |
| First posted | 2023-05-30 | ClinicalTrials.gov |
| Last updated | 2026-03-27 | ClinicalTrials.gov |
Registered outcomes 17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change from baseline in participant's meal timing measured by questionnaires. | 12 months | Daily time of the eating window (hours) and the daily fasting period (hours) willk be assesed through questionniares to record the meal time every day. | ClinicalTrials.gov |
| Primary | Change from baseline in participant's postprandial glucose levels | 12 months | Glucose levels will be continuously monitores with glucose sensors. Glucose levels (mg/dL) 30, 60, 120 and 240 minutes after meals will be recorded. | ClinicalTrials.gov |
| Primary | Change from baseline in fat mass measured by bioimpedance | 12 months | % of fat mass will be recorded by bioimpedance | ClinicalTrials.gov |
| Primary | Change from baseline in muscle mass measured by bioimpedance | 12 months | % of muscle mass will be recorded by bioimpedance | ClinicalTrials.gov |
| Primary | Change from baseline in the blood concentration of metabolites as measured by MNR | 12 months | MNR will be used to quantified the concentration of metabolites in blood and urine samples | ClinicalTrials.gov |
| Primary | Change from baseline in chronotype assessed by the morningness/eveningness (MEQ)questionnaire | 12 months | The chronotype classification from extreme morning phenotype to extreme evening phenotype will be assessed by the MEQ questionnaires and changes in classification from baseline will be assessed | ClinicalTrials.gov |
| Primary | Change from baseline in sleep quality as measured with the Pittsburg's questionnaire | 12 months | The scores obtained in Pittsburg's questionnaires in each visit will be compared with the baseline scores with mixes linear models. The score ranges from 0 to 20. Higher scores in the Pittsburg's questionnaire means worse sleeping quality. | ClinicalTrials.gov |
| Primary | Changes form baseline in cognitive function scores measured by the Rey Auditory Verbal Learning Test (RAVLT). | 12 months | The scores obtained in RAVLT in each visit will be compared with the baseline scores with mixes linear models. The raw scores are corrected by age group and shown as percentil score. Higher percentile means better performance in the test. | ClinicalTrials.gov |
| Primary | Changes form baseline in cognitive function scores measured by STROOP color and Word test. | 12 months | The T scores obtained in the STROOP test in each visit will be compared with the baseline scores with mixes linear models. Scores range from 20 to 80. Higher scores means better cognitive performance. | ClinicalTrials.gov |
| Primary | Changes from baseline in the Emotional Eating Questionnaire. | 12 months | Changes in the classification from emotional eater to non-emotional eater will be compared among visits. | ClinicalTrials.gov |
| Primary | Changes from baseline in anxiety scores measured by the Hamilton Anxiety Rating Scale | 12 months | The anxiety scores obtained in each visit will be compared with the baseline scores with mixes linear models. Higher anxiety scores means higher degree of anxiety feeling. The score ranges from 0 to 56. A score of 17 or less indicates mild anxiety severity. A score from 18 to 24 indicates mild to moderate anxiety severity. Lastly, a score of 25 to 30 indicates a moderate to severe anxiety severity. | ClinicalTrials.gov |
| Primary | Changes from baseline in mood scores measured by the EVEA Scale for Mood Assessment. | 12 months | The 0-10 scores obtained in the sadness-depression, anxiety, anger/hostility and cheerfulness domains in each visit will be compared with the baseline scores with mixed linear models. Higher scores in each domains means a higher magnitude of the corresponding feeling. Scores range form 0 to 10. | ClinicalTrials.gov |
| Primary | Changes from baseline in health-related quality of life measured by the SF-36 questionnaire | 12 months | The scores obtained in the different domains of the health-related quality of life questionnaire, and in the aggregated physical and mental component will be recorded and compared between visits with mixes linear models. Normalized scores range from 0 to 100 with higher scores meaning better quality of life. | ClinicalTrials.gov |
| Primary | Changes from baseline in well-being measured by the W-BQ12 questionnaire. | 12 months | The total scores obtained in the well-being questionnaire in each visit will be compared with the baseline scores with mixes linear models. Scores range from 0 to 36 and higher score means better perception of well-being. | ClinicalTrials.gov |
| Primary | Changes from baseline in the accumulation of autophagy vacuoles | 12 months | The dynamics of autophagy will be measured through the analysis of accumulation of autophagy vacuoles in participant's T lymphocytes and changes in the number of vacuoles comparing with baseline will be analyzed by mixed linear models. | ClinicalTrials.gov |
| Primary | Changes from baseline in biological age measured by the Horvath's DNAmPhenoage algorithm | 12 months | DNA methylation will be quantified with Illumina Infinium EPIC V2.0 array and the change in methylation levels will be combined with changes in phenotypic features included in teh DNAmPhenoage algorithm. Changes comparing with baseline will be analyzed by mixed linear models. | ClinicalTrials.gov |
| Primary | Changes from baseline in the percentage of senescent T cells | 12 months | Percentage of senescent T cells will be assessed by FACS using CD3 as T lymphocyte marker and CD28 as marker of senescent T cells. Percentage of senescent T cells will be calculated as the (nº of senecent T cells / Total T cells)\*100. Changes from baseline will be analyzed by mixed linear models | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Verbal Learning | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)