Cyclists, Supplementation
Conditions
Brief summary
A double-blind, placebo-controlled, randomised, with two arms (product and placebo) unicentric clinical trial to analyse the efficacy on physical performance parameters of a product designed for sport during a lapse of two weeks (7 days).
Detailed description
After recruitment, subject will be randomised and allocated to one group of the 2 study arms: treatment group or control group (placebo). A simple randomisation will be performed using software by a random number generator, and assigned to participants.
Interventions
DIETARY_SUPPLEMENTβ-alanine
7 days of consumption
DIETARY_SUPPLEMENTwheat semolina
7 days of consumption
Sponsors
Universidad Católica San Antonio de Murcia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
* Not respecting rest the day before physical tests. * Not being in a fasted state (at least 2 h from last meal). * Having consumed stimulants acutely before the trial, or under drug treatment affecting perceived effort of the trial. * Not being available to perform every trial on the same conditions at the same time of the day. * Not sticking to the same diet, 24 h before each trial.
Exclusion criteria
* Adverse event * Protocol violation * Lost to follow-up * Allergy to any of the components of the treatment or placebo product. This includes allergy to β-alanine, wheat, soy, nuts (including peanuts), sesame and its byproducts.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue | Change of baseline rate of perceived exertion at seven days | Rate of perceived exertion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Performance outcomes | It will be measured on two different occasions. Day one and seven days later. | Physical performance is measured by direct variables: mean power output (MPO) and peak power output by ergometer (Cyclus 2) together with cadence. |
| Paresthesia test | It will be measured on three different occasions. Twice on day 1 (before and after consumption) and seven days after. | Visual analogue scale (1-10) |
| Microcapillary blood | It will be measured on two different occasions. Day one and seven days later. | This test provides biochemical variables (ABL90FLEX). |
Countries
Spain
Outcome results
None listed