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

Sponsor
University of Padova (Other)
Overall Status
Completed
CT.gov ID
NCT04320784
Collaborator
University of Palermo (Other), University of Pavia (Other)
16
Enrollment
1
Location
2
Arms
4.2
Actual Duration (Months)
3.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Time restricted eating
  • Other: Control
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
16 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
It is a single blind, parallel arms studyIt is a single blind, parallel arms study
Masking:
Single (Outcomes Assessor)
Masking Description:
Outcome assessor treated anonymus data
Primary Purpose:
Basic Science
Official Title:
Effects of 4 Weeks of Time Restricted Eating Protocol on Performance, Metabolism and Blood Outcomes in Elite Cyclists
Actual Study Start Date :
Jan 6, 2018
Actual Primary Completion Date :
Mar 30, 2018
Actual Study Completion Date :
May 15, 2018

Arms and Interventions

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

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. VO2max [4 weeks]

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

    2. fat mass [4 weeks]

      fat mass measured through body impedence analyser

    3. lean body mass [4 weeks]

      lean body mass mass measured through body impedence analyser

    Secondary Outcome Measures

    1. white blood cells [4 weeks]

      white blood cells as thousands per microliter

    2. Eosinophils [4 weeks]

      Eosinophils as percentage of total white blood cells

    3. Monocytes [4 weeks]

      Monocytes as percentage of total white blood cells

    4. Basophiles [4 weeks]

      Basophiles s percentage of total white blood cells

    5. Hematocrit [4 weeks]

      Hematocrit as percentage

    6. Haemoglobin [4 weeks]

      Haemoglobin as gram per Liter

    7. Mean cell volume [4 weeks]

      mean cell volume as femtonLiter

    8. mean cell haemoglobin [4 weeks]

      mean cell haemoglobin as picograms

    9. ESR (Erythrocyte sedimentation rate ) [4 weeks]

      ESR as millimeters per hour

    10. CRP (C-reactive protein) [4 weeks]

      CRP as milligram per deciliter

    11. Total cholesterol [4 weeks]

      Total cholesterol as milligram per deciliter

    12. TG (triglycerides) [4 weeks]

      TG as milligram per deciliter

    13. glucose [4 weeks]

      glucose as milligram per deciliter

    14. creatinine [4 weeks]

      creatinine as milligram per deciliter

    15. creatin kinase [4 weeks]

      creatin kinase as milligram per deciliter

    16. iron [4 weeks]

      iron as microgram per deciliter

    17. ferritin [4 weeks]

      ferritin as microgram per liter

    18. transferrin [4 weeks]

      ferritin as milligram per deciliter

    19. TSH (Thyroid Stimulating Hormone) [4 weeks]

      TSH as micro international unit per milliliter

    20. T3 (triiodothyronine) free [4 weeks]

      T3 free as picogram per milliliter

    21. Testosterone free [4 weeks]

      Testosterone free as picogram per milliliter

    22. IL-6 [4 weeks]

      IL-6 as picogram per milliliter

    23. TNFalfa [4 weeks]

      TNFalfa as picogram per milliliter

    24. IGF-1 [4 weeks]

      IGF-1 as nanogram per milliliter

    25. Insulin [4 weeks]

      Insulin micro international unit per milliliter

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 24 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nutrition and Exercise Lab, DSB, University of Padova Padova Italy 35131

    Sponsors and Collaborators

    • University of Padova
    • University of Palermo
    • University of Pavia

    Investigators

    • Principal Investigator: Antonio Paoli, MD, University of Padova

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Antonio Paoli, Full Professor, University of Padova
    ClinicalTrials.gov Identifier:
    NCT04320784
    Other Study ID Numbers:
    • AP1019
    First Posted:
    Mar 25, 2020
    Last Update Posted:
    Mar 25, 2020
    Last Verified:
    Mar 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Antonio Paoli, Full Professor, University of Padova
    fasting, cyclists, athletes, time restricted eating, performance, body composition.

    Study Results

    No Results Posted as of Mar 25, 2020