Fasting and Performance Clinical Trial
— TRECYCOfficial title:
Effects of 4 Weeks of Time Restricted Eating Protocol on Performance, Metabolism and Blood Outcomes in Elite Cyclists
| 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 |
| Verified date | March 2020 |
| Source | University of Padova |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| Italy | Nutrition and Exercise Lab, DSB, University of Padova | Padova |
| Lead Sponsor | Collaborator |
|---|---|
| University of Padova | University of Palermo, University of Pavia |
Italy,
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
| 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 |