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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04320784
Other study ID # AP1019
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 6, 2018
Est. completion date May 15, 2018

Study information

Verified date March 2020
Source University of Padova
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date May 15, 2018
Est. primary completion date March 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 24 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Italy Nutrition and Exercise Lab, DSB, University of Padova Padova

Sponsors (3)

Lead Sponsor Collaborator
University of Padova University of Palermo, University of Pavia

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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 f — View Citation

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). pii: E719. doi: 10.3390/nu11040719. Review. — View Citation

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: 10.1080/17461391.2 — View Citation

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: 10.109 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary VO2max Maximal oxygen consumption (in ml O2/Kg/min) measured during a cycloergometer incremental test through a gas analyses 4 weeks
Primary fat mass fat mass measured through body impedence analyser 4 weeks
Primary lean body mass lean body mass mass measured through body impedence analyser 4 weeks
Secondary white blood cells white blood cells as thousands per microliter 4 weeks
Secondary Eosinophils Eosinophils as percentage of total white blood cells 4 weeks
Secondary Monocytes Monocytes as percentage of total white blood cells 4 weeks
Secondary Basophiles Basophiles s percentage of total white blood cells 4 weeks
Secondary Hematocrit Hematocrit as percentage 4 weeks
Secondary Haemoglobin Haemoglobin as gram per Liter 4 weeks
Secondary Mean cell volume mean cell volume as femtonLiter 4 weeks
Secondary mean cell haemoglobin mean cell haemoglobin as picograms 4 weeks
Secondary ESR (Erythrocyte sedimentation rate ) ESR as millimeters per hour 4 weeks
Secondary CRP (C-reactive protein) CRP as milligram per deciliter 4 weeks
Secondary Total cholesterol Total cholesterol as milligram per deciliter 4 weeks
Secondary TG (triglycerides) TG as milligram per deciliter 4 weeks
Secondary glucose glucose as milligram per deciliter 4 weeks
Secondary creatinine creatinine as milligram per deciliter 4 weeks
Secondary creatin kinase creatin kinase as milligram per deciliter 4 weeks
Secondary iron iron as microgram per deciliter 4 weeks
Secondary ferritin ferritin as microgram per liter 4 weeks
Secondary transferrin ferritin as milligram per deciliter 4 weeks
Secondary TSH (Thyroid Stimulating Hormone) TSH as micro international unit per milliliter 4 weeks
Secondary T3 (triiodothyronine) free T3 free as picogram per milliliter 4 weeks
Secondary Testosterone free Testosterone free as picogram per milliliter 4 weeks
Secondary IL-6 IL-6 as picogram per milliliter 4 weeks
Secondary TNFalfa TNFalfa as picogram per milliliter 4 weeks
Secondary IGF-1 IGF-1 as nanogram per milliliter 4 weeks
Secondary Insulin Insulin micro international unit per milliliter 4 weeks