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

Study Overview
=================
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.

Official Title
-----------------
Effects of 4 Weeks of Time Restricted Eating Protocol on Performance, Metabolism and Blood Outcomes in Elite Cyclists

Conditions
-----------------
Fasting and Performance

Intervention / Treatment
-----------------
* Other: Time restricted eating
* Other: Control


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 24 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: It is a single blind, parallel arms study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Time restricted eating (TRE)<br>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<br>* TRE group consumed 100% of its estimated daily energy needs in an 8-hour time window: from 10:00 AM to 6:00 PM<br>* Other names: TRE;|
| Active Comparator: Control (CTRL)<br>CTRL group consumed 100% of its estimated daily energy needs in 3 meals between 7:00 AM and 9:00 PM | Other: Control<br>* CTRL group consumed 100% of its estimated daily energy needs in 3 meals between 7:00 AM and 9:00 PM<br>* Other names: CTRL;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VO2max | Maximal oxygen consumption (in ml O2/Kg/min) measured during a cycloergometer incremental test through a gas analyses | 4 weeks | 
| fat mass | fat mass measured through body impedence analyser | 4 weeks | 
| lean body mass | lean body mass mass measured through body impedence analyser | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| white blood cells | white blood cells as thousands per microliter | 4 weeks | 
| Eosinophils | Eosinophils as percentage of total white blood cells | 4 weeks | 
| Monocytes | Monocytes as percentage of total white blood cells | 4 weeks | 
| Basophiles | Basophiles s percentage of total white blood cells | 4 weeks | 
| Hematocrit | Hematocrit as percentage | 4 weeks | 
| Haemoglobin | Haemoglobin as gram per Liter | 4 weeks | 
| Mean cell volume | mean cell volume as femtonLiter | 4 weeks | 
| mean cell haemoglobin | mean cell haemoglobin as picograms | 4 weeks | 
| ESR (Erythrocyte sedimentation rate ) | ESR as millimeters per hour | 4 weeks | 
| CRP (C-reactive protein) | CRP as milligram per deciliter | 4 weeks | 
| Total cholesterol | Total cholesterol as milligram per deciliter | 4 weeks | 
| TG (triglycerides) | TG as milligram per deciliter | 4 weeks | 
| glucose | glucose as milligram per deciliter | 4 weeks | 
| creatinine | creatinine as milligram per deciliter | 4 weeks | 
| creatin kinase | creatin kinase as milligram per deciliter | 4 weeks | 
| iron | iron as microgram per deciliter | 4 weeks | 
| ferritin | ferritin as microgram per liter | 4 weeks | 
| transferrin | ferritin as milligram per deciliter | 4 weeks | 
| TSH (Thyroid Stimulating Hormone) | TSH as micro international unit per milliliter | 4 weeks | 
| T3 (triiodothyronine) free | T3 free as picogram per milliliter | 4 weeks | 
| Testosterone free | Testosterone free as picogram per milliliter | 4 weeks | 
| IL-6 | IL-6 as picogram per milliliter | 4 weeks | 
| TNFalfa | TNFalfa as picogram per milliliter | 4 weeks | 
| IGF-1 | IGF-1 as nanogram per milliliter | 4 weeks | 
| Insulin | Insulin micro international unit per milliliter | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fasting, cyclists, athletes, time restricted eating, performance, body composition.