Effects of a Time Restricted Eating Protocol on Cyclists (TRECYC) (TRECYC)

March 21, 2020 updated by: Antonio Paoli, University of Padova

Effects of 4 Weeks of Time Restricted Eating Protocol on Performance, Metabolism and Blood Outcomes in Elite Cyclists

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.

Study Overview

Status

Completed

Detailed Description

Sixteen elite under-23 cyclists were randomly assigned to a TRE group or to a control group (CTRL) with a traditional meal pattern. The TRE group consumed 100% of its estimated daily energy needs in an 8-hour time window: from 10:00 AM (ante meridiem) to 6:00 PM (post meridiem) whilst the CTRL group consumed 100% of its estimated daily energy needs in 3 meals between 7:00 AM and 9:00 PM. During the experimental period, training loads were similar in the two groups. Athletes were tested before and after 4 weeks of the intervention. Body composition , basal metabolism, performances indexes and blood parameters were measured.

Study Type

Interventional

Enrollment (Actual)

16

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

18 years to 24 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • elite under 23 cyclists male

Exclusion Criteria:

  • adherence to special diets
  • use of nutritional supplements (except a daily multivitamin-mineral and/or protein supplement)
  • 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)
TRE group consumed 100% of its estimated daily energy needs in an 8-hour time window: from 10:00 AM to 6:00 PM
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 Names:
  • TRE
ACTIVE_COMPARATOR: Control (CTRL)
CTRL group consumed 100% of its estimated daily energy needs in 3 meals between 7:00 AM and 9:00 PM
CTRL group consumed 100% of its estimated daily energy needs in 3 meals between 7:00 AM and 9:00 PM
Other Names:
  • CTRL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VO2max
Time Frame: 4 weeks
Maximal oxygen consumption (in ml O2/Kg/min) measured during a cycloergometer incremental test through a gas analyses
4 weeks
fat mass
Time Frame: 4 weeks
fat mass measured through body impedence analyser
4 weeks
lean body mass
Time Frame: 4 weeks
lean body mass mass measured through body impedence analyser
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
white blood cells
Time Frame: 4 weeks
white blood cells as thousands per microliter
4 weeks
Eosinophils
Time Frame: 4 weeks
Eosinophils as percentage of total white blood cells
4 weeks
Monocytes
Time Frame: 4 weeks
Monocytes as percentage of total white blood cells
4 weeks
Basophiles
Time Frame: 4 weeks
Basophiles s percentage of total white blood cells
4 weeks
Hematocrit
Time Frame: 4 weeks
Hematocrit as percentage
4 weeks
Haemoglobin
Time Frame: 4 weeks
Haemoglobin as gram per Liter
4 weeks
Mean cell volume
Time Frame: 4 weeks
mean cell volume as femtonLiter
4 weeks
mean cell haemoglobin
Time Frame: 4 weeks
mean cell haemoglobin as picograms
4 weeks
ESR (Erythrocyte sedimentation rate )
Time Frame: 4 weeks
ESR as millimeters per hour
4 weeks
CRP (C-reactive protein)
Time Frame: 4 weeks
CRP as milligram per deciliter
4 weeks
Total cholesterol
Time Frame: 4 weeks
Total cholesterol as milligram per deciliter
4 weeks
TG (triglycerides)
Time Frame: 4 weeks
TG as milligram per deciliter
4 weeks
glucose
Time Frame: 4 weeks
glucose as milligram per deciliter
4 weeks
creatinine
Time Frame: 4 weeks
creatinine as milligram per deciliter
4 weeks
creatin kinase
Time Frame: 4 weeks
creatin kinase as milligram per deciliter
4 weeks
iron
Time Frame: 4 weeks
iron as microgram per deciliter
4 weeks
ferritin
Time Frame: 4 weeks
ferritin as microgram per liter
4 weeks
transferrin
Time Frame: 4 weeks
ferritin as milligram per deciliter
4 weeks
TSH (Thyroid Stimulating Hormone)
Time Frame: 4 weeks
TSH as micro international unit per milliliter
4 weeks
T3 (triiodothyronine) free
Time Frame: 4 weeks
T3 free as picogram per milliliter
4 weeks
Testosterone free
Time Frame: 4 weeks
Testosterone free as picogram per milliliter
4 weeks
IL-6
Time Frame: 4 weeks
IL-6 as picogram per milliliter
4 weeks
TNFalfa
Time Frame: 4 weeks
TNFalfa as picogram per milliliter
4 weeks
IGF-1
Time Frame: 4 weeks
IGF-1 as nanogram per milliliter
4 weeks
Insulin
Time Frame: 4 weeks
Insulin micro international unit per milliliter
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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 6, 2018

Primary Completion (ACTUAL)

March 30, 2018

Study Completion (ACTUAL)

May 15, 2018

Study Registration Dates

First Submitted

March 19, 2020

First Submitted That Met QC Criteria

March 21, 2020

First Posted (ACTUAL)

March 25, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 25, 2020

Last Update Submitted That Met QC Criteria

March 21, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

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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