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

Healthy Diet Clinical Trial

— FaTE-TRE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04503005
• Other study ID #: FaTE-TRE
• Status: Recruiting
• Phase: N/A
• Start date: March 8, 2021
• Est. completion date: August 31, 2022

Study information

• Verified date: April 2021
• Source: University of Padova
• Contact: Tatiana Moro, Ph.D
• Phone: 0498275306
• Email: tatiana.moro[@]unipd.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Fasting, Intermittent
• Healthy Diet

Intervention

Other:
• Time Restricted Eating
Effect of 16, 14 or 12 hours of daily fasting

Locations

Country	Name	City	State
Italy	Nutrition and Exercise Lab, DSB, University of Padova	Padova

Sponsors (1)

Lead Sponsor	Collaborator
University of Padova

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body composition	change of body fat percentage measured via DEXA	2 months
Secondary	Blood cholesterol (total, HDL, LDL)	Change in blood lipid profile	2 months
Secondary	Blood cytokines (IL-6; IL-1, TNF-a)	Change in blood inflammatory markers	2 months
Secondary	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