- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05880095
Healthy Aging Through Time- Restricted Eating in Adults With Overweight/Obesity and Incipient Liver Disease: ENSATI (ENSATI)
Healthy Aging Through Time- Restricted Eating in Adults With Overweight/Obesity and Incipient Liver Disease: the ENSATI Study
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:
- If TRE is sustainable over 6-months.
- If TRE positively affects metabolism and body composition
- If TRE improves circadian rhythm/sleep.
- If TRE benefits cognitive function, mood and quality of life (QoL).
- 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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lidia D Daimiel Ruiz, PhD
- Phone Number: 309 917278100
- Email: lidia.daimiel@alimentacion.imdea.org
Study Locations
-
-
-
Madrid, Spain, 28049
- Recruiting
- IMDEA Food
-
Sub-Investigator:
- Cristina Climent Mainar
-
Contact:
- Lidia Daimiel Ruiz, PhD
- Phone Number: 309 +34 917278100
- Email: lidia.daimiel@alimentacion.imdea.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- BMI: 27-35 Kg/m2
- Prevalent fatty liver disease (FLI > 59 or echography screening) EASL, Clinical Practice Guidelines for the management of non-alcoholic fatty liver disease, 2016.
- Habitual daily eating window ≥ 14 h
- Regular sleeping patterns (7 ± 2 sleeping hours every day)
- Stable weight during the last 3 months (weight changes ≤ 4 Kg)
- Not considering changes in thei physical activity in the following 6 months
- Not being under a weight-loss program or medication.
Exclusion Criteria:
- Non-menopausal women
- Alcohol abuse (CAGE score > 2, Ewing, 1984; Malet et al. 2005)
- Change in smoking habits in the previous 6 months.
- Prevalent renal, cardiovascular, liver (excluding fatty liver), endocrine o pancreatic disease.
- Type 1 diabetes
- Type 2 diabetes with poor glucose control.
- Poorly control hypertension.
- Medical treatment affecting weight or sleep.
- Food allergies or intolerances affecting the adherence to the intervention.
- Eating disorders.
- Shift workers.
- Participants of other studies.
- Social factors affecting to the adherence to the intervention (being institutionalized, unable to ingest solid food).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Unrestricted Mediterranean diet (MedD)
The aim of this group is to serve as control group.
Participants will be advised to adhere to a traditional Mediterranean diet
|
Participants will received nutritional educational information to encourage their adherence to a Mediterranean dietary pattern.
Neither caloric restriction nor time-eating restriction will be indicated.
Other Names:
|
Experimental: Energy-reduced Mediterranean diet (MedD_RC)
The aim of this group is to allow the comparison between a traditional caloric restriction approach and a time-restricted eating program without caloric restriction.
|
Participants will follow a Mediterranean diet with a 25% caloric restriction.
Participants will be provided with dietary programs, menus, shopping lists and other educational material to encourage adherence to the intervention.
Other Names:
|
Experimental: Mediterranean diet with time-restricted eating (MedD_TRE)
This is the intervention group designed to asses the main hypothesis.
|
Participants will follow the same dietary guidelines given to MedD group, but they must to adjust their daily meals to a self-selected 10-hour eating window.
This 10h eating window of their choice should be comprised between 6.00 to 20.00h.
Participants will be allowed to consume water and non-caloric drinks during the fasting period (outside the 10h eating window).
Participants will be advised to follow the 10h TRE during weekdays and weekends.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in participant's meal timing measured by questionnaires.
Time Frame: 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.
|
12 months
|
Change from baseline in participant's postprandial glucose levels
Time Frame: 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.
|
12 months
|
Change from baseline in fat mass measured by bioimpedance
Time Frame: 12 months
|
% of fat mass will be recorded by bioimpedance
|
12 months
|
Change from baseline in muscle mass measured by bioimpedance
Time Frame: 12 months
|
% of muscle mass will be recorded by bioimpedance
|
12 months
|
Change from baseline in the blood concentration of metabolites as measured by MNR
Time Frame: 12 months
|
MNR will be used to quantified the concentration of metabolites in blood and urine samples
|
12 months
|
Change from baseline in chronotype assessed by the morningness/eveningness (MEQ)questionnaire
Time Frame: 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
|
12 months
|
Changes form baseline in cognitive function scores measured by the Rey Auditory Verbal Learning Test (RAVLT).
Time Frame: 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.
|
12 months
|
Changes from baseline in the Emotional Eating Questionnaire.
Time Frame: 12 months
|
Changes in the classification from emotional eater to non-emotional eater will be compared among visits.
|
12 months
|
Changes from baseline in mood scores measured by the EVEA Scale for Mood Assessment.
Time Frame: 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.
|
12 months
|
Changes from baseline in health-related quality of life measured by the SF-36 questionnaire
Time Frame: 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.
|
12 months
|
Changes from baseline in well-being measured by the W-BQ12 questionnaire.
Time Frame: 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.
|
12 months
|
Changes from baseline in the accumulation of autophagy vacuoles
Time Frame: 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.
|
12 months
|
Changes from baseline in biological age measured by the Horvath's DNAmPhenoage algorithm
Time Frame: 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.
|
12 months
|
Changes from baseline in the percentage of senescent T cells
Time Frame: 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
|
12 months
|
Change from baseline in sleep quality as measured with the Pittsburg's questionnaire
Time Frame: 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.
|
12 months
|
Changes form baseline in cognitive function scores measured by STROOP color and Word test.
Time Frame: 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.
|
12 months
|
Changes from baseline in anxiety scores measured by the Hamilton Anxiety Rating Scale
Time Frame: 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.
|
12 months
|
Collaborators and Investigators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IMD: PI-057
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Study Data/Documents
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Biological Aging
-
University of Massachusetts, AmherstNational Institutes of Health (NIH); National Institute on Aging (NIA); University...Recruiting
-
Elysium HealthUniversity of OxfordNot yet recruitingBiological Aging
-
Abbott NutritionCompletedBiological AgingUnited Kingdom
-
University Hospital, ToulouseEuropean Regional Development FundRecruitingBiological AgingFrance
-
University Ramon LlullQueen's University, Belfast; University of Southern Denmark; University of Ulm; University of Glasgow and other collaboratorsCompletedPhysical Activity | Physical Function | Sedentary Behaviour | Frail Older Adults | Biological Aging | Controlled Clinical Trials, Randomized | Exercise Referral SchemesSpain
-
University of Colorado, DenverGilead Sciences; National Institute on Aging (NIA)CompletedInflammation | Obesity | HIV | Aging, BiologicalUnited States
-
Fundació EurecatCirce, S.L.Not yet recruiting
-
Centre Hospitalier Universitaire, AmiensRecruitingBiological SamplesFrance
-
DaacroISTITUTO KURZ ITALIA S.R.L.; Institut Kurz GmbH; Fattoria La Vialla di Gianni...CompletedBiological AvailabilityGermany
-
Wageningen UniversityCompletedBiological Availability
Clinical Trials on Unrestricted Mediterranean diet
-
Purdue UniversityMushroom CouncilCompleted
-
Massachusetts General HospitalShireCompletedChronic Kidney DiseaseUnited States
-
University of East AngliaNewcastle UniversityRecruitingDepression, AnxietyUnited Kingdom
-
University of California, IrvineCompletedPolycythemia Vera | Essential Thrombocythemia | Myelofibrosis | Myeloproliferative Disorder | Myeloproliferative SyndromeUnited States
-
Gangnam Severance HospitalUnknown
-
Federico II UniversityCompletedMediterranean Diet | Neuroendocrine Tumours (NETs)Italy
-
Azienda Ospedaliera Specializzata in Gastroenterologia...Completed
-
University of California, DavisCompletedInflammation | Diet Modification | HDLUnited States
-
michal rollUnknown
-
University of Campania "Luigi Vanvitelli"CompletedType 2 Diabetes MellitusItaly