Clinical trial NCT04668378: Effects of a Time Restricted Eating Protocol on Resistance Training Men
Official title: Effects of Time-restricted Eating and Resistance Training on Body Composition, Inflammatory Markers and Cardiometabolic Risk Factors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fasting
Healthy
Keywords: fasting
time restricted eating
resistance training
body composition
inflammation
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2020-12-16
Enrollment: 34
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: It is a single blind, parallel arms study
Primary purpose: BASIC_SCIENCE

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Fat Mass
timeFrame: change from baseline to up to 2 months
measure: Fat Free Mass
timeFrame: change from baseline to up to 2 months
Secondary outcomes:
measure: Fat Mass
timeFrame: change from baseline to up to 12 months
measure: Fat Free Mass
timeFrame: change from baseline to up to 12 months
measure: total cholesterol
timeFrame: change from baseline to up to 2 months
measure: total cholesterol
timeFrame: change from baseline to up to 12 months
measure: glucose
timeFrame: change from baseline to up to 2 months
measure: glucose
timeFrame: change from baseline to up to 12 months
measure: Leg muscle strength
timeFrame: change from baseline to up to 2 months
measure: Leg muscle strength
timeFrame: change from baseline to up to 12 months
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Nutrition and Exercise Lab, DSB, University of Padova
Study officials:
affiliation: University of Padova
name: Antonio Paoli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.