Fasting Time Effects in Time-Restricted Eating (FaTE-TRE)

Study Overview
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Brief Summary
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Over the past century, lifestyles and eating habits have rapidly changed, helping to increase the onset of conditions such as obesity, metabolic syndrome and the risk of cardiovascular and metabolic diseases such as diabetes. Recently, dietary regimens such as calorie restriction and intermittent fasting have been promoted as new strategies for reducing obesity and related co-morbidities. These strategies have proven effective in reducing body fat, improving blood pressure, lipid profile and insulin resistance in overweight individuals. However, due to the rigidity of these food protocols, the adherence of subjects to the diet is often limited or maintained only for short periods. Time-Restricted Eating (TRE) is a less extreme form of intermittent fasting, in which the subject's daily calorie intake is consumed only in a certain period of time during the day (normally 8-12 hours). TRE have been able to reduce fat mass, pro-inflammatory markers (eg IL-6, TNF-a) and have improved some biomarkers related to cardiovascular risks (eg Insulin, HDL, TG). The literature offers numerous versions of intermittent fasting, and the role of fasting duration is not yet fully clear. Thus. the aim of the present study is to investigate the effect od different duration of fasting in a TRE protocol on body composition and lipid and inflammatory profile. Moreover, the study intended to explore the effect of 2 month of TRE on long term maintenance of diet habits, body composition, lipid and inflammatory profile.

Official Title
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Effect of Fasting Duration During a Time-Restricted Eating Diet Protocol

Conditions
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Healthy Diet, Fasting, Intermittent

Intervention / Treatment
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* Other: Time Restricted Eating


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI between 18-30 kg/m2 Stable body weight for at least 3 months Exclusion Criteria: type 2 Diabetes or pre-diabetes for ADA guidelines Significant Chronic disease recent and acute inflammatory status Recent (within 3 months) treatment with anabolic steroids, systemic corticosteroids or estrogen. regular exercise training (≥ 2 sessions/week) or ≥ 10,000 steps/day

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Effect of fasting duration<br>study the effect of different daily fasting duration on body composition and blood lipid and inflammatory markers in healthy adults. | Other: Time Restricted Eating<br>* Effect of 16, 14 or 12 hours of daily fasting<br>|
| Other: Effect of time restricted eating protocol on chronotype<br>study the effect of 2 month of time restricted eating on the chronotype profile of healthy adults. | Other: Time Restricted Eating<br>* Effect of 16, 14 or 12 hours of daily fasting<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition | change of body fat percentage measured via DEXA | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood cholesterol (total, HDL, LDL) | Change in blood lipid profile | 2 months | 
| Blood cytokines (IL-6; IL-1, TNF-a) | Change in blood inflammatory markers | 2 months | 
| Morningness-Eveningness Questionnaire (MEQ) on chronotype | effect od diet in eating behaviours. Minimum value is 16, maximum value is 86 Morningness-Eveningness Questionnaire (MEQ) scale is 0-41, evening type; 42-58 Neither-type; 58-68 Morning-type | 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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time restricted eating, intermitted fasting, body composition, metabolism, inflammation