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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Italy
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Other: Time restricted eating
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
Other: Control
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Padova

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Palermo
University of Pavia

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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 6, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 15, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 19, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AP1019

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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