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

University of Padova

Status: Unknown

Conditions: Healthy Diet; Fasting, Intermittent

Treatments: Other: Time Restricted Eating

Study type: Interventional

Funder types: Other

Identifiers

NCT04503005

FaTE-TRE

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Effect of fasting duration

Active Comparator group

Description:

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

Treatment:

Other: Time Restricted Eating

Effect of time restricted eating protocol on chronotype

Other group

Description:

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

Treatment:

Other: Time Restricted Eating