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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04503005
Other study ID # FaTE-TRE
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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