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Fasting and PerformanceTRECYCNCT04320784

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

A study testing Time restricted eating in people with Fasting and Performance, run by University of Padova at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 24 years, men onlyHealthy volunteers can take part
Conditions the study is for
Fasting and Performance
What is being tested?
Time restricted eating
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteItaly
Study dates
6 Jan 2018to 15 May 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 24 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • elite under 23 cyclists male

Who cannot join

  • adherence to special diets
  • use of nutritional supplements (except a daily multivitamin-mineral and/or protein supplement)
  • use of medications

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Nutrition and Exercise Lab, DSB, University of Padova

    Padova, 35131

Other trials in Italy

About this study

Official title: 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.

Read the 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.

Being tested
Time restricted eating, Control
Keywords
fasting, cyclists, athletes, time restricted eating, performance, body composition.
Medical subject headings
Fasting, Intermittent Fasting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Time restricted eatingOther

    Also called 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

  • ControlOther

    Also called CTRL

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

Study groups in NCT04320784
Study groupRoleWhat they receive
Time restricted eating (TRE)ExperimentalTRE group consumed 100% of its estimated daily energy needs in an 8-hour time window: from 10:00 AM to 6:00 PM
Receives: Other: Time restricted eating
Control (CTRL)Active comparatorCTRL group consumed 100% of its estimated daily energy needs in 3 meals between 7:00 AM and 9:00 PM
Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. VO2max

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

    Measured: 4 weeks

  2. fat mass

    fat mass measured through body impedence analyser

    Measured: 4 weeks

  3. lean body mass

    lean body mass mass measured through body impedence analyser

    Measured: 4 weeks

Secondary outcomes (25)

  1. white blood cells

    white blood cells as thousands per microliter

    Measured: 4 weeks

  2. Eosinophils

    Eosinophils as percentage of total white blood cells

    Measured: 4 weeks

  3. Monocytes

    Monocytes as percentage of total white blood cells

    Measured: 4 weeks

  4. Basophiles

    Basophiles s percentage of total white blood cells

    Measured: 4 weeks

  5. Hematocrit

    Hematocrit as percentage

    Measured: 4 weeks

  6. Haemoglobin

    Haemoglobin as gram per Liter

    Measured: 4 weeks

  7. Mean cell volume

    mean cell volume as femtonLiter

    Measured: 4 weeks

  8. mean cell haemoglobin

    mean cell haemoglobin as picograms

    Measured: 4 weeks

  9. ESR (Erythrocyte sedimentation rate )

    ESR as millimeters per hour

    Measured: 4 weeks

  10. CRP (C-reactive protein)

    CRP as milligram per deciliter

    Measured: 4 weeks

  11. Total cholesterol

    Total cholesterol as milligram per deciliter

    Measured: 4 weeks

  12. TG (triglycerides)

    TG as milligram per deciliter

    Measured: 4 weeks

  13. glucose

    glucose as milligram per deciliter

    Measured: 4 weeks

  14. creatinine

    creatinine as milligram per deciliter

    Measured: 4 weeks

  15. creatin kinase

    creatin kinase as milligram per deciliter

    Measured: 4 weeks

  16. iron

    iron as microgram per deciliter

    Measured: 4 weeks

  17. ferritin

    ferritin as microgram per liter

    Measured: 4 weeks

  18. transferrin

    ferritin as milligram per deciliter

    Measured: 4 weeks

  19. TSH (Thyroid Stimulating Hormone)

    TSH as micro international unit per milliliter

    Measured: 4 weeks

  20. T3 (triiodothyronine) free

    T3 free as picogram per milliliter

    Measured: 4 weeks

  21. Testosterone free

    Testosterone free as picogram per milliliter

    Measured: 4 weeks

  22. IL-6

    IL-6 as picogram per milliliter

    Measured: 4 weeks

  23. TNFalfa

    TNFalfa as picogram per milliliter

    Measured: 4 weeks

  24. IGF-1

    IGF-1 as nanogram per milliliter

    Measured: 4 weeks

  25. Insulin

    Insulin micro international unit per milliliter

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2020
  2. Study start6 Jan 2018
  3. Primary completion30 Mar 2018
  4. Study completion15 May 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Model description
It is a single blind, parallel arms study
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04320784
Sponsor's protocol ID
AP1019
Acronym
TRECYC
Status last verified
Mar 2020
First submitted
19 Mar 2020
Last updated
25 Mar 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 30925707

  • 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.

    PubMed 27737674

  • 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.

    PubMed 27550719

  • 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.

    PubMed 31268131

  • 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.

    PubMed 33308259

Questions about this trial

What is this clinical trial studying?

A study testing Time restricted eating in people with Fasting and Performance, run by University of Padova at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

VO2max (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04320784, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2020.

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