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

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. 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.

Conditions

• Biological Aging

Interventions

OTHER

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.

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.

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.

Sponsors & Collaborators

• Ministerio de Ciencia e Innovación, Spain

  collaborator OTHER_GOV

• CIBER Fisiopatología de la Obesidad y la Nutrición

  collaborator UNKNOWN

• IMDEA Food

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

55 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-07-05

Primary Completion

2026-03-15

Completion

2026-03-15

Countries

• Spain

Study Locations