- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04320784
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
Conditions
Intervention / Treatment
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
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Padova, Italy, 35131
- Nutrition and Exercise Lab, DSB, University of Padova
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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:
|
|
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:
|
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
|
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lean body mass
Time Frame: 4 weeks
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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
|
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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
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creatinine as milligram per deciliter
|
4 weeks
|
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creatin kinase
Time Frame: 4 weeks
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creatin kinase as milligram per deciliter
|
4 weeks
|
|
iron
Time Frame: 4 weeks
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iron as microgram per deciliter
|
4 weeks
|
|
ferritin
Time Frame: 4 weeks
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ferritin as microgram per liter
|
4 weeks
|
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transferrin
Time Frame: 4 weeks
|
ferritin as milligram per deciliter
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4 weeks
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TSH (Thyroid Stimulating Hormone)
Time Frame: 4 weeks
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TSH as micro international unit per milliliter
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4 weeks
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T3 (triiodothyronine) free
Time Frame: 4 weeks
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T3 free as picogram per milliliter
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4 weeks
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Testosterone free
Time Frame: 4 weeks
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Testosterone free as picogram per milliliter
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4 weeks
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IL-6
Time Frame: 4 weeks
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IL-6 as picogram per milliliter
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4 weeks
|
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TNFalfa
Time Frame: 4 weeks
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TNFalfa as picogram per milliliter
|
4 weeks
|
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IGF-1
Time Frame: 4 weeks
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IGF-1 as nanogram per milliliter
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4 weeks
|
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Insulin
Time Frame: 4 weeks
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Insulin micro international unit per milliliter
|
4 weeks
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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.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
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
Other Study ID 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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