- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04668378
Effects of a Time Restricted Eating Protocol on Resistance Training Men
December 15, 2020 updated by: Antonio Paoli, University of Padova
Effects of Time-restricted Eating and Resistance Training on Body Composition, Inflammatory Markers and Cardiometabolic Risk Factors
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
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
34
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 Locations
-
-
-
Padova, Italy, 35131
- 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
20 years to 40 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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
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: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
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.
|
ND group ingested their caloric intake as three meals consumed at 8 a.m., 1 p.m. and 8 p.m.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fat Mass
Time Frame: change from baseline to up to 2 months
|
fat mass measured dual energy X-ray absorptiometry (DXA)
|
change from baseline to up to 2 months
|
|
Fat Free Mass
Time Frame: change from baseline to up to 2 months
|
fat free mass measured dual energy X-ray absorptiometry (DXA)
|
change from baseline to up to 2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fat Mass
Time Frame: change from baseline to up to 12 months
|
fat mass measured dual energy X-ray absorptiometry (DXA)
|
change from baseline to up to 12 months
|
|
Fat Free Mass
Time Frame: change from baseline to up to 12 months
|
fat free mass measured dual energy X-ray absorptiometry (DXA)
|
change from baseline to up to 12 months
|
|
total cholesterol
Time Frame: change from baseline to up to 2 months
|
total cholesterol as milligram per deciliter
|
change from baseline to up to 2 months
|
|
total cholesterol
Time Frame: change from baseline to up to 12 months
|
total cholesterol as milligram per deciliter
|
change from baseline to up to 12 months
|
|
glucose
Time Frame: change from baseline to up to 2 months
|
glucose as milligram per deciliter
|
change from baseline to up to 2 months
|
|
glucose
Time Frame: change from baseline to up to 12 months
|
glucose as milligram per deciliter
|
change from baseline to up to 12 months
|
|
Leg muscle strength
Time Frame: change from baseline to up to 2 months
|
Leg muscle strength measured via via 1-RM test
|
change from baseline to up to 2 months
|
|
Leg muscle strength
Time Frame: change from baseline to up to 12 months
|
Leg muscle strength measured via via 1-RM test
|
change from baseline to up to 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
January 1, 2014
Primary Completion (ACTUAL)
March 31, 2015
Study Completion (ACTUAL)
August 31, 2017
Study Registration Dates
First Submitted
December 4, 2020
First Submitted That Met QC Criteria
December 14, 2020
First Posted (ACTUAL)
December 16, 2020
Study Record Updates
Last Update Posted (ACTUAL)
December 17, 2020
Last Update Submitted That Met QC Criteria
December 15, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- TRE-RET
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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