Healthy Aging Through Time- Restricted Eating in Adults With Overweight/Obesity and Incipient Liver Disease: ENSATI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

175 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-05

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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

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Biological Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Open, controlled, randomized, parallel groups trial

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Intervention groups will be randomly assessed letters A, B or C. Data analists will used masked groups in the analysis.

Study Groups

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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

Group Type EXPERIMENTAL

Unrestricted Mediterranean diet

Intervention Type OTHER

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 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.

Group Type EXPERIMENTAL

Energy-reduced Mediterranean diet

Intervention Type OTHER

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 eating (MedD_TRE)

This is the intervention group designed to asses the main hypothesis.

Group Type EXPERIMENTAL

Mediterranean diet with time-restricted eating

Intervention Type OTHER

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.

Interventions

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Unrestricted 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.

Intervention Type OTHER

Energy-reduced Mediterranean diet

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.

Intervention Type OTHER

Mediterranean diet with time-restricted eating

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.

Intervention Type OTHER

Other Intervention Names

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MedD MEdD_RC MedD_TRE

Eligibility Criteria

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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).

Minimum Eligible Age

55 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No