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

Sponsor
University of Padova (Other)
Overall Status
Recruiting
CT.gov ID
NCT04503005
Collaborator
(none)
40
1
2
17.8
2.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Time Restricted Eating
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Effect of Fasting Duration During a Time-Restricted Eating Diet Protocol
Actual Study Start Date :
Mar 8, 2021
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Aug 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Effect of fasting duration

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

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

Other: 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.

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

Outcome Measures

Primary Outcome Measures

  1. Body composition [2 months]

    change of body fat percentage measured via DEXA

Secondary Outcome Measures

  1. Blood cholesterol (total, HDL, LDL) [2 months]

    Change in blood lipid profile

  2. Blood cytokines (IL-6; IL-1, TNF-a) [2 months]

    Change in blood inflammatory markers

  3. Morningness-Eveningness Questionnaire (MEQ) on chronotype [6 month]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Nutrition and Exercise Lab, DSB, University of Padova Padova Italy 35131

Sponsors and Collaborators

  • University of Padova

Investigators

  • Principal Investigator: Tatiana Moro, Ph.D, University of Padova

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Antonio Paoli, Full Professor, University of Padova
ClinicalTrials.gov Identifier:
NCT04503005
Other Study ID Numbers:
  • FaTE-TRE
First Posted:
Aug 6, 2020
Last Update Posted:
Apr 26, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Antonio Paoli, Full Professor, University of Padova

Study Results

No Results Posted as of Apr 26, 2021