Biological AgingENSATINCT05880095
Healthy Aging Through Time- Restricted Eating in Adults With Overweight/Obesity and Incipient Liver Disease: ENSATI
A study testing Unrestricted Mediterranean diet, Energy-reduced Mediterranean diet and Mediterranean diet with time-restricted eating in people with Biological Aging, run by IMDEA Food at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 55 to 70 years
- Conditions the study is for
- Biological Aging
- What is being tested?
- Unrestricted Mediterranean diet, Energy-reduced Mediterranean diet and Mediterranean diet with time-restricted eating
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteSpain
- Study dates
- 5 Jul 2023to 15 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
- 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.
Read the detailed description
Aging has been defined as the time-dependent functional decline that affects most living organisms, and this biological process occurs with great variability from person to person. Healthy aging refers to developing and maintaining functional abilities to enable the well-being of the elderly. Therefore, promoting healthy aging strategies in the population would result in people living in a healthy state for most of their lifespan. This would have an important socio-economic impact, considering that aging is a risk factor for multiple diseases and that the proportion of older persons continues to increase. Interestingly, healthy lifestyle habits such as proper nutrition and physical exercise could attenuate the progression of aging-related diseases and ameliorate age-related decline. Among the lifestyle interventions that could improve healthspan, time restricted eating (TRE) is a promising candidate. TRE is a type of intermittent fasting that involves time-limited consumption of food during a specific time window. This dietary intervention has a demonstrated positive impact on some aspects of health both in pre-clinical models and clinical trials. The beneficial effects of TRE can occur at different physiological levels that are related to healthy aging, such as metabolism and body composition, circadian rhythms and sleep, and cognitive function. However, the mechanisms through which TRE may influence these aspects are not fully understood. Therefore, and considering current evidence pointing to a beneficial effect of TRE on health, the hypothesis is that an intervention with TRE in overweight/obese individuals has a positive impact on their aging determinants (metabolism and body composition, circadian rhythms and sleep, quality of life, and cognitive function) which is associated with favorable changes in cellular traits of aging (autophagy, immunosenescence, and biological age). This is a controlled, randomized, parallel group intervention trial to assess the effect of TRE, in comparison with traditional caloric restriction and unrestricted diet on phenotypic and molecular aging parameters.
- Conditions
- Biological Aging
- Being tested
- Unrestricted Mediterranean diet, Energy-reduced Mediterranean diet, Mediterranean diet with time-restricted eating
- Keywords
- Clinical trial, Time-restricted eating, Healthy aging, Epigenetics, Obesity, Precision nutrition, Autophagy, Metabolism
- Medical subject headings
- Intermittent Fasting, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unrestricted Mediterranean dietOther
Also called MedD
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.
Energy-reduced Mediterranean dietOther
Also called MEdD_RC
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.
Mediterranean diet with time-restricted eatingOther
Also called MedD_TRE
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.
| Study group | Role | What they receive |
|---|---|---|
| Unrestricted Mediterranean diet (MedD) | Experimental | The aim of this group is to serve as control group. Participants will be advised to adhere to a traditional Mediterranean diet Receives: Other: Unrestricted Mediterranean diet |
| Energy-reduced Mediterranean diet (MedD_RC) | Experimental | 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. Receives: Other: Energy-reduced Mediterranean diet |
| Mediterranean diet with time-restricted eating (MedD_TRE) | Experimental | This is the intervention group designed to asses the main hypothesis. Receives: Other: Mediterranean diet with time-restricted eating |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in participant's meal timing measured by questionnaires.
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.
Measured: 12 months
Change from baseline in participant's postprandial glucose levels
Glucose levels will be continuously monitores with glucose sensors. Glucose levels (mg/dL) 30, 60, 120 and 240 minutes after meals will be recorded.
Measured: 12 months
Change from baseline in fat mass measured by bioimpedance
% of fat mass will be recorded by bioimpedance
Measured: 12 months
Change from baseline in muscle mass measured by bioimpedance
% of muscle mass will be recorded by bioimpedance
Measured: 12 months
Change from baseline in the blood concentration of metabolites as measured by MNR
MNR will be used to quantified the concentration of metabolites in blood and urine samples
Measured: 12 months
Change from baseline in chronotype assessed by the morningness/eveningness (MEQ)questionnaire
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
Measured: 12 months
Change from baseline in sleep quality as measured with the Pittsburg's questionnaire
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.
Measured: 12 months
Changes form baseline in cognitive function scores measured by the Rey Auditory Verbal Learning Test (RAVLT).
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.
Measured: 12 months
Changes form baseline in cognitive function scores measured by STROOP color and Word test.
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.
Measured: 12 months
Changes from baseline in the Emotional Eating Questionnaire.
Changes in the classification from emotional eater to non-emotional eater will be compared among visits.
Measured: 12 months
Changes from baseline in anxiety scores measured by the Hamilton Anxiety Rating Scale
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.
Measured: 12 months
Changes from baseline in mood scores measured by the EVEA Scale for Mood Assessment.
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.
Measured: 12 months
Changes from baseline in health-related quality of life measured by the SF-36 questionnaire
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.
Measured: 12 months
Changes from baseline in well-being measured by the W-BQ12 questionnaire.
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.
Measured: 12 months
Changes from baseline in the accumulation of autophagy vacuoles
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.
Measured: 12 months
Changes from baseline in biological age measured by the Horvath's DNAmPhenoage algorithm
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.
Measured: 12 months
Changes from baseline in the percentage of senescent T cells
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start5 Jul 2023
- Primary completion15 Mar 2026
- Study completion15 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biological AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open, controlled, randomized, parallel groups trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- IMDEA Food
- Sponsor type
- University, hospital or other
- Collaborators
- Ministerio de Ciencia e Innovación, Spain, CIBER Fisiopatología de la Obesidad y la Nutrición
- Responsible party
- Principal investigator, Lidia Daimiel Ruiz, IMDEA Food
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05880095
- Sponsor's protocol ID
- IMD: PI-057
- Acronym
- ENSATI
- Status last verified
- Mar 2026
- First submitted
- 16 Mar 2023
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Codified data and samples would be made available to other researchers upon request to the principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Aging Through Time- Restricted Eating in Adults With Overweight/Obesity and Incipient Liver Disease: the ENSATI Study
- ClinicalTrials.gov ID
- NCT05880095
- Acronym / sponsor ID
- ENSATI / IMD: PI-057
- Conditions
- Biological Aging
- Keywords
- Clinical trial, Time-restricted eating, Healthy aging, Epigenetics, Obesity, Precision nutrition, Autophagy, Metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- IMDEA FoodUniversity, hospital or other
- Collaborators
- Ministerio de Ciencia e Innovación, Spain, CIBER Fisiopatología de la Obesidad y la Nutrición
- Study start
- 5 Jul 2023 (actual)
- Primary completion
- 15 Mar 2026 (actual)
- Study completion
- 15 Mar 2026 (actual)
- First posted
- 30 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Aging has been defined as the time-dependent functional decline that affects most living organisms, and this biological process occurs with great variability from person to person. Healthy aging refers to developing and maintaining functional abilities to enable the well-being of the elderly. Therefore, promoting healthy aging strategies in the population would result in people living in a healthy state for most of their lifespan. This would have an important socio-economic impact, considering that aging is a risk factor for multiple diseases and that the proportion of older persons continues to increase. Interestingly, healthy lifestyle habits such as proper nutrition and physical exercise could attenuate the progression of aging-related diseases and ameliorate age-related decline. Among the lifestyle interventions that could improve healthspan, time restricted eating (TRE) is a promising candidate. TRE is a type of intermittent fasting that involves time-limited consumption of food during a specific time window. This dietary intervention has a demonstrated positive impact on some aspects of health both in pre-clinical models and clinical trials. The beneficial effects of TRE can occur at different physiological levels that are related to healthy aging, such as metabolism and body composition, circadian rhythms and sleep, and cognitive function. However, the mechanisms through which TRE may influence these aspects are not fully understood. Therefore, and considering current evidence pointing to a beneficial effect of TRE on health, the hypothesis is that an intervention with TRE in overweight/obese individuals has a positive impact on their aging determinants (metabolism and body composition, circadian rhythms and sleep, quality of life, and cognitive function) which is associated with favorable changes in cellular traits of aging (autophagy, immunosenescence, and biological age). This is a controlled, randomized, parallel group intervention trial to assess the effect of TRE, in comparison with traditional caloric restriction and unrestricted diet on phenotypic and molecular aging parameters.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Open, controlled, randomized, parallel groups trial
| Arm | Type | Receives |
|---|---|---|
| Unrestricted Mediterranean diet (MedD) | Experimental | Other: Unrestricted Mediterranean dietThe aim of this group is to serve as control group. Participants will be advised to adhere to a traditional Mediterranean diet |
| Energy-reduced Mediterranean diet (MedD_RC) | Experimental | Other: Energy-reduced Mediterranean dietThe aim of this group is to allow the comparison between a traditional caloric restriction approach and a time-restricted eating program without caloric restriction. |
| Mediterranean diet with time-restricted eating (MedD_TRE) | Experimental | Other: Mediterranean diet with time-restricted eatingThis is the intervention group designed to asses the main hypothesis. |
Who may qualify
- Ages
- 55 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unrestricted Mediterranean dietAlso: MedDParticipants 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 | Unrestricted Mediterranean diet (MedD) |
| Energy-reduced Mediterranean dietAlso: MEdD_RCParticipants 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 | Energy-reduced Mediterranean diet (MedD_RC) |
| Mediterranean diet with time-restricted eatingAlso: MedD_TREParticipants 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 | Mediterranean diet with time-restricted eating (MedD_TRE) |
Primary outcome
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.
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.
Change from baseline in fat mass measured by bioimpedance
Time frame: 12 months
% of fat mass will be recorded by bioimpedance
Change from baseline in muscle mass measured by bioimpedance
Time frame: 12 months
% of muscle mass will be recorded by bioimpedance
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
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Clinical trial websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. Codified data and samples would be made available to other researchers upon request to the principal investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unrestricted Mediterranean diet, Energy-reduced Mediterranean diet and Mediterranean diet with time-restricted eating in people with Biological Aging, run by IMDEA Food at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in participant's meal timing measured by questionnaires. (time frame: 12 months). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.