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CompletedNCT04668378Updated Dec 17, 2020

Effects of a Time Restricted Eating Protocol on Resistance Training Men

An interventional study of Time restricted eating and Normal Diet in Fasting and Healthy, sponsored by University of Padova. Completed at 1 site in Italy. Open to male participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-12-17.

Sponsored by University of Padova · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 6 years 11 months after the study started (first participant enrolled Jan 2014, registered Dec 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
Male
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Study 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

Read the 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.

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Conditions studied

  • Fasting
  • Healthy

Keywords

  • fasting
  • time restricted eating
  • resistance training
  • body composition
  • inflammation
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In context

Lead sponsor

University of Padova is the lead sponsor of 210 studies on the registry; 42 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
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

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
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
34 participants (actual)

Study arms

  • 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

  • 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

  • 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

  • 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

Interventions

  • OtherTime 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.

  • OtherNormal Diet

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

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What researchers measure

Primary outcomes

  1. Fat Mass

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

    Time frame: change from baseline to up to 2 months

  2. Fat Free Mass

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

    Time frame: change from baseline to up to 2 months

Secondary outcomes

  1. Fat Mass

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

    Time frame: change from baseline to up to 12 months

  2. Fat Free Mass

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

    Time frame: change from baseline to up to 12 months

  3. total cholesterol

    total cholesterol as milligram per deciliter

    Time frame: change from baseline to up to 2 months

  4. total cholesterol

    total cholesterol as milligram per deciliter

    Time frame: change from baseline to up to 12 months

  5. glucose

    glucose as milligram per deciliter

    Time frame: change from baseline to up to 2 months

  6. glucose

    glucose as milligram per deciliter

    Time frame: change from baseline to up to 12 months

  7. Leg muscle strength

    Leg muscle strength measured via via 1-RM test

    Time frame: change from baseline to up to 2 months

  8. Leg muscle strength

    Leg muscle strength measured via via 1-RM test

    Time frame: change from baseline to up to 12 months

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Study locations

1 site
  • Nutrition and Exercise Lab, DSB, University of Padova
    Padova, 35131, Italy
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References and documents

Publications

  • 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. PubMed 34649266 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04668378
Lead sponsor
University of Padova
Responsible party
Antonio Paoli (Full Professor, University of Padova) — Principal investigator
First posted
Dec 16, 2020
Start date
Jan 1, 2014
Primary completion
Mar 31, 2015
Completion
Aug 31, 2017
Last update
Dec 17, 2020

Study contacts

Antonio Paoli, MD
principal investigator · University of Padova

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

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