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Completed

NCT Number: NCT05880095

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

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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Key information

Conditions

Biological Aging Behavior Body Weight Fasting Feeding Behavior Intermittent Fasting Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

55 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IMDEA Food

Madrid, 28049, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Unrestricted Mediterranean diet

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.

Other names: MedD

Energy-reduced Mediterranean diet

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.

Other names: MEdD_RC

Mediterranean diet with time-restricted eating

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.

Other names: MedD_TRE

Primary outcomes

  1. 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.

  2. 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.

  3. Change from baseline in fat mass measured by bioimpedance

    Time frame: 12 months

    % of fat mass will be recorded by bioimpedance

  4. Change from baseline in muscle mass measured by bioimpedance

    Time frame: 12 months

    % of muscle mass will be recorded by bioimpedance

  5. 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

  6. 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

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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

Sponsors and collaborators

Lead sponsor

IMDEA Food

Other

Collaborators

  • CIBER Fisiopatología de la Obesidad y la Nutrición
  • Ministerio de Ciencia e Innovación, Spain

Registry information

Official study title

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

Acronym: ENSATI

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 30, 2023
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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