Effects of a Time Restricted Eating Protocol on Resistance Training Men

Sponsor

University of Padova (Other)

Overall Status

Completed

CT.gov ID

NCT04668378

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study sought to investigate the effects of 16/8 time restricted eating (TRE) with windows of 16 hours of fasting and 8 hours of eating on on body composition, muscle strength, and metabolic factors during resistance training in healthy resistance trained males

Condition or Disease	Intervention/Treatment	Phase
Fasting Healthy	Other: Time restricted eating Other: Normal Diet	N/A

Detailed Description

Thirty-four resistance-trained males were randomly assigned to a TRE group or to a control normal pattern group (ND) with a traditional meal pattern. The TRE group consumed 100% of the daily energy needs in an 8-hour time window: from 1PM (post meridiem) to 8:00 PM whilst the ND group consumed 100% of their daily energy needs in 3 meals between 8:00 AM (ante meridiem) and 8:00 PM. During the experimental period, training loads were similar and standardize in the two groups. partecipants were tested before and after 8 weeks of the intervention. Body composition , basal metabolism, performances indexes and blood parameters were measured. After the completition of the first two months of study, subjects were ask to volunteer to continue the intervention for 10 extra months. A total of twenty subjects from, 10 from each group (TRE or ND) continued and completed the second part of the study.

Study Design

Study Type:

Interventional

Actual Enrollment :

34 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

It is a single blind, parallel arms studyIt is a single blind, parallel arms study

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

Effects of Time-restricted Eating and Resistance Training on Body Composition, Inflammatory Markers and Cardiometabolic Risk Factors

Actual Study Start Date :

Jan 1, 2014

Actual Primary Completion Date :

Mar 31, 2015

Actual Study Completion Date :

Aug 31, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Time restricted eating (TRE) - two month partecipants underwent 2 months of a TRE protocol, during which they consumed 100% of the daily energy needs in an 8-hour time window: from 1:00 PM to 8:00 PM. Body composition, muscle strength and blood parameters were measured before and after the diet intervention.	Other: Time restricted eating TRE subjects consumed 100 % of their energy needs divided into three meals consumed at 1 p.m., 4 p.m. and 8 p.m., and fasted for the remaining 16 h per 24-h period.
Active Comparator: Normal Diet (ND) - two month partecipants underwent 2 months of a regular diet schedule and consumed 100% of the daily energy needs in 3 meals between 8:00 AM and 8:00 PM. Body composition, muscle strength and blood parameters were measured before and after the diet intervention.	Other: Normal Diet ND group ingested their caloric intake as three meals consumed at 8 a.m., 1 p.m. and 8 p.m.
Experimental: Time restricted eating (TRE) - twelve month partecipants underwent 12 months of a TRE protocol, during which they consumed 100% of the daily energy needs in an 8-hour time window: from 1:00 PM to 8:00 PM. Body composition, muscle strength and blood parameters were measured before and after the diet intervention.	Other: Time restricted eating TRE subjects consumed 100 % of their energy needs divided into three meals consumed at 1 p.m., 4 p.m. and 8 p.m., and fasted for the remaining 16 h per 24-h period.
Active Comparator: Normal Diet (ND) - twelve month partecipants underwent 12 months of a regular diet schedule and consumed 100% of the daily energy needs in 3 meals between 8:00 AM and 8:00 PM. Body composition, muscle strength and blood parameters were measured before and after the diet intervention.	Other: Normal Diet ND group ingested their caloric intake as three meals consumed at 8 a.m., 1 p.m. and 8 p.m.

Outcome Measures

Primary Outcome Measures

Fat Mass [change from baseline to up to 2 months]
fat mass measured dual energy X-ray absorptiometry (DXA)
Fat Free Mass [change from baseline to up to 2 months]
fat free mass measured dual energy X-ray absorptiometry (DXA)

Secondary Outcome Measures

Fat Mass [change from baseline to up to 12 months]
fat mass measured dual energy X-ray absorptiometry (DXA)
Fat Free Mass [change from baseline to up to 12 months]
fat free mass measured dual energy X-ray absorptiometry (DXA)
total cholesterol [change from baseline to up to 2 months]
total cholesterol as milligram per deciliter
total cholesterol [change from baseline to up to 12 months]
total cholesterol as milligram per deciliter
glucose [change from baseline to up to 2 months]
glucose as milligram per deciliter
glucose [change from baseline to up to 12 months]
glucose as milligram per deciliter
Leg muscle strength [change from baseline to up to 2 months]
Leg muscle strength measured via via 1-RM test
Leg muscle strength [change from baseline to up to 12 months]
Leg muscle strength measured via via 1-RM test

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 40 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

continuously engaged in resistance training for at least 5 years
at least 3 years experience in split training routines
male

Exclusion Criteria:

adherence to special diets
use of nutritional supplements (except a daily multivitamin-mineral and/or protein supplement)
use of steroids
use of medications

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: Antonio Paoli, MD, 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:

NCT04668378

Other Study ID Numbers:

TRE-RET

First Posted:

Dec 16, 2020

Last Update Posted:

Dec 17, 2020

Last Verified:

Dec 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Antonio Paoli, Full Professor, University of Padova

fasting

time restricted eating

resistance training

body composition

inflammation

Study Results

No Results Posted as of Dec 17, 2020