Effect of Fasting Duration During a Time-Restricted Eating Diet Protocol
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Body composition
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Body composition
Time Frame: 2 months
change of body fat percentage measured via DEXA
Secondary Outcomes
- Blood cholesterol (total, HDL, LDL)(2 months)
- Blood cytokines (IL-6; IL-1, TNF-a)(2 months)
- Morningness-Eveningness Questionnaire (MEQ) on chronotype(6 month)
Investigators
Antonio Paoli
Full Professor
University of Padova