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

April 22, 2021 updated by: Antonio Paoli, University of Padova

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Padova, Italy, 35131
        • Recruiting
        • Nutrition and Exercise Lab, DSB, University of Padova

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body composition
Time Frame: 2 months
change of body fat percentage measured via DEXA
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood cholesterol (total, HDL, LDL)
Time Frame: 2 months
Change in blood lipid profile
2 months
Blood cytokines (IL-6; IL-1, TNF-a)
Time Frame: 2 months
Change in blood inflammatory markers
2 months
Morningness-Eveningness Questionnaire (MEQ) on chronotype
Time Frame: 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
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Padova

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2021

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

August 31, 2022

Study Registration Dates

First Submitted

July 30, 2020

First Submitted That Met QC Criteria

August 4, 2020

First Posted (Actual)

August 6, 2020

Study Record Updates

Last Update Posted (Actual)

April 26, 2021

Last Update Submitted That Met QC Criteria

April 22, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FaTE-TRE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

There is not a plan to make IPD available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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