NCT04668378

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2015

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2017

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

December 4, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 16, 2020

Completed
Last Updated

December 17, 2020

Status Verified

December 1, 2020

Enrollment Period

1.2 years

First QC Date

December 4, 2020

Last Update Submit

December 15, 2020

Conditions

Keywords

fastingtime restricted eatingresistance trainingbody compositioninflammation

Outcome Measures

Primary Outcomes (2)

  • Fat Mass

    fat mass measured dual energy X-ray absorptiometry (DXA)

    change from baseline to up to 2 months

  • Fat Free Mass

    fat free mass measured dual energy X-ray absorptiometry (DXA)

    change from baseline to up to 2 months

Secondary Outcomes (8)

  • Fat Mass

    change from baseline to up to 12 months

  • Fat Free Mass

    change from baseline to up to 12 months

  • total cholesterol

    change from baseline to up to 2 months

  • total cholesterol

    change from baseline to up to 12 months

  • glucose

    change from baseline to up to 2 months

  • +3 more secondary outcomes

Study Arms (4)

Time restricted eating (TRE) - two month

EXPERIMENTAL

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

Normal Diet (ND) - two month

ACTIVE COMPARATOR

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

Time restricted eating (TRE) - twelve month

EXPERIMENTAL

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

Normal Diet (ND) - twelve month

ACTIVE COMPARATOR

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

Interventions

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.

Time restricted eating (TRE) - twelve monthTime restricted eating (TRE) - two month

ND group ingested their caloric intake as three meals consumed at 8 a.m., 1 p.m. and 8 p.m.

Normal Diet (ND) - twelve monthNormal Diet (ND) - two month

Eligibility Criteria

Age20 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nutrition and Exercise Lab, DSB, University of Padova

Padua, 35131, Italy

Location

Related Publications (1)

  • Moro T, Tinsley G, Pacelli FQ, Marcolin G, Bianco A, Paoli A. Twelve Months of Time-restricted Eating and Resistance Training Improves Inflammatory Markers and Cardiometabolic Risk Factors. Med Sci Sports Exerc. 2021 Dec 1;53(12):2577-2585. doi: 10.1249/MSS.0000000000002738.

MeSH Terms

Conditions

FastingIntermittent FastingInflammation

Condition Hierarchy (Ancestors)

Feeding BehaviorBehaviorPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Antonio Paoli, MD

    University of Padova

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: It is a single blind, parallel arms study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor

Study Record Dates

First Submitted

December 4, 2020

First Posted

December 16, 2020

Study Start

January 1, 2014

Primary Completion

March 31, 2015

Study Completion

August 31, 2017

Last Updated

December 17, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations