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

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-08

Study Completion Date

2022-08-31

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.

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Detailed Description

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Conditions

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Healthy Diet Fasting, Intermittent

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Effect of fasting duration

study the effect of different daily fasting duration on body composition and blood lipid and inflammatory markers in healthy adults.

Group Type ACTIVE_COMPARATOR

Time Restricted Eating

Intervention Type OTHER

Effect of 16, 14 or 12 hours of daily fasting

Effect of time restricted eating protocol on chronotype

study the effect of 2 month of time restricted eating on the chronotype profile of healthy adults.

Group Type OTHER

Time Restricted Eating

Intervention Type OTHER

Effect of 16, 14 or 12 hours of daily fasting

Interventions

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Time Restricted Eating

Effect of 16, 14 or 12 hours of daily fasting

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes