NCT04320784

Brief Summary

We sought to investigate the effects of 4 weeks of 16/8 time restricted eating (TRE) with windows of 16 hours of fasting and 8 hours of eating) on elite cyclists' performance, metabolic and blood parameters.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 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 6, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2018

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

March 19, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 25, 2020

Completed
Last Updated

March 25, 2020

Status Verified

March 1, 2020

Enrollment Period

3 months

First QC Date

March 19, 2020

Last Update Submit

March 21, 2020

Conditions

Fasting and Performance

Keywords

fasting, cyclists, athletes, time restricted eating, performance, body composition.

Outcome Measures

Primary Outcomes (3)

  • VO2max

    Maximal oxygen consumption (in ml O2/Kg/min) measured during a cycloergometer incremental test through a gas analyses

    4 weeks

  • fat mass

    fat mass measured through body impedence analyser

    4 weeks

  • lean body mass

    lean body mass mass measured through body impedence analyser

    4 weeks

Secondary Outcomes (25)

  • white blood cells

    4 weeks

  • Eosinophils

    4 weeks

  • Monocytes

    4 weeks

  • Basophiles

    4 weeks

  • Hematocrit

    4 weeks

  • +20 more secondary outcomes

Study Arms (2)

Time restricted eating (TRE)

EXPERIMENTAL

TRE group consumed 100% of its estimated daily energy needs in an 8-hour time window: from 10:00 AM to 6:00 PM

Other: Time restricted eating

Control (CTRL)

ACTIVE COMPARATOR

CTRL group consumed 100% of its estimated daily energy needs in 3 meals between 7:00 AM and 9:00 PM

Other: Control

Interventions

Time restricted eatingOTHER

TRE group consumed 100% of its estimated daily energy needs in an 8-hour time window: from 10:00 AM to 6:00 PM

Also known as: TRE
Time restricted eating (TRE)
ControlOTHER

CTRL group consumed 100% of its estimated daily energy needs in 3 meals between 7:00 AM and 9:00 PM

Also known as: CTRL
Control (CTRL)

Eligibility Criteria

Age18 Years - 24 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • elite under 23 cyclists 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 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 (5)

  • Paoli A, Tinsley G, Bianco A, Moro T. The Influence of Meal Frequency and Timing on Health in Humans: The Role of Fasting. Nutrients. 2019 Mar 28;11(4):719. doi: 10.3390/nu11040719.

    PMID: 30925707RESULT

  • Moro T, Tinsley G, Bianco A, Marcolin G, Pacelli QF, Battaglia G, Palma A, Gentil P, Neri M, Paoli A. Effects of eight weeks of time-restricted feeding (16/8) on basal metabolism, maximal strength, body composition, inflammation, and cardiovascular risk factors in resistance-trained males. J Transl Med. 2016 Oct 13;14(1):290. doi: 10.1186/s12967-016-1044-0.

    PMID: 27737674RESULT

  • Tinsley GM, Forsse JS, Butler NK, Paoli A, Bane AA, La Bounty PM, Morgan GB, Grandjean PW. Time-restricted feeding in young men performing resistance training: A randomized controlled trial. Eur J Sport Sci. 2017 Mar;17(2):200-207. doi: 10.1080/17461391.2016.1223173. Epub 2016 Aug 22.

    PMID: 27550719RESULT

  • Tinsley GM, Moore ML, Graybeal AJ, Paoli A, Kim Y, Gonzales JU, Harry JR, VanDusseldorp TA, Kennedy DN, Cruz MR. Time-restricted feeding plus resistance training in active females: a randomized trial. Am J Clin Nutr. 2019 Sep 1;110(3):628-640. doi: 10.1093/ajcn/nqz126.

    PMID: 31268131RESULT

  • Moro T, Tinsley G, Longo G, Grigoletto D, Bianco A, Ferraris C, Guglielmetti M, Veneto A, Tagliabue A, Marcolin G, Paoli A. Time-restricted eating effects on performance, immune function, and body composition in elite cyclists: a randomized controlled trial. J Int Soc Sports Nutr. 2020 Dec 11;17(1):65. doi: 10.1186/s12970-020-00396-z.

    PMID: 33308259DERIVED

MeSH Terms

Conditions

FastingIntermittent Fasting

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

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
Masking Details
Outcome assessor treated anonymus data
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

March 19, 2020

First Posted

March 25, 2020

Study Start

January 6, 2018

Primary Completion

March 30, 2018

Study Completion

May 15, 2018

Last Updated

March 25, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)