Clinical trial NCT04320784: Effects of a Time Restricted Eating Protocol on Cyclists (TRECYC)
Official title: Effects of 4 Weeks of Time Restricted Eating Protocol on Performance, Metabolism and Blood Outcomes in Elite Cyclists
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fasting and Performance
Keywords: fasting, cyclists, athletes, time restricted eating, performance, body composition.
Lead sponsor: University of Padova
Sponsor class: OTHER
Collaborators: name: University of Palermo
name: University of Pavia
First posted: 2020-03-25
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: It is a single blind, parallel arms study
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: VO2max
timeFrame: 4 weeks
measure: fat mass
timeFrame: 4 weeks
measure: lean body mass
timeFrame: 4 weeks
Secondary outcomes:
measure: white blood cells
timeFrame: 4 weeks
measure: Eosinophils
timeFrame: 4 weeks
measure: Monocytes
timeFrame: 4 weeks
measure: Basophiles
timeFrame: 4 weeks
measure: Hematocrit
timeFrame: 4 weeks
measure: Haemoglobin
timeFrame: 4 weeks
measure: Mean cell volume
timeFrame: 4 weeks
measure: mean cell haemoglobin
timeFrame: 4 weeks
measure: ESR (Erythrocyte sedimentation rate )
timeFrame: 4 weeks
measure: CRP (C-reactive protein)
timeFrame: 4 weeks
measure: Total cholesterol
timeFrame: 4 weeks
measure: TG (triglycerides)
timeFrame: 4 weeks
measure: glucose
timeFrame: 4 weeks
measure: creatinine
timeFrame: 4 weeks
measure: creatin kinase
timeFrame: 4 weeks
measure: iron
timeFrame: 4 weeks
measure: ferritin
timeFrame: 4 weeks
measure: transferrin
timeFrame: 4 weeks
measure: TSH (Thyroid Stimulating Hormone)
timeFrame: 4 weeks
measure: T3 (triiodothyronine) free
timeFrame: 4 weeks
measure: Testosterone free
timeFrame: 4 weeks
measure: IL-6
timeFrame: 4 weeks
measure: TNFalfa
timeFrame: 4 weeks
measure: IGF-1
timeFrame: 4 weeks
measure: Insulin
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Nutrition and Exercise Lab, DSB, University of Padova
Study officials:
affiliation: University of Padova
name: Antonio Paoli, MD
role: PRINCIPAL_INVESTIGATOR
References:
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):719. doi: 10.3390/nu11040719.
citation: 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.
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: 10.1080/17461391.2016.1223173. Epub 2016 Aug 22.
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: 10.1093/ajcn/nqz126.
citation: 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.