Betaine Effect in Speed-strength Athletes

Supplementation Clinical Trial

Official title:

The Effect of Betaine Supplementation on Body Composition and Physical Capacity of Speed-strength Male Athletes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03702205
• Other study ID #: ULS00005
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: October 15, 2018
• Est. completion date: October 12, 2021

Study information

• Verified date: September 2020
• Source: Poznan University of Life Sciences
• Contact: Emilia E Zawieja, MSc
• Phone: +48 61 846 60 57
• Email: emilia.zawieja[@]up.poznan.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is aimed at assessing the influence of two betaine doses (2.5 g∙d-1 and 5 g∙d-1) supplemented for three weeks in a group of speed-strength trained athletes on anaerobic capacity in Wingate test, performance in CrossFit-like exercise test - Fight Gone Bad, alterations in body compositions and total body water.

Description:

The main aim of the project is the assessment of the effects of 3 weeks supplementation with two doses of betaine (2.5 g∙d-1 and 5 g∙d-1) on anaerobic capacity, CrossFit performance, body composition, and betaine metabolism in a group of male speed-strength trained athletes.

The study is designed as a double-blind, randomized, placebo-controlled crossover trial. 80 male participants will be divided randomly into two parallel groups: one receiving 2.5 g·d-1 betaine and the second receiving 5 g·d-1 betaine. In both experimental groups participants will receive both betaine supplement or placebo in a random order. The supplementation periods (betaine and placebo) will last for three weeks each and will be separated by a 3-week washout. The participants will attend four study meetings at the Institute of Human Nutrition and Dietetics, Poznan University of Life Sciences, Poland. Food intake before and during the intervention will be assessed with the use of food diary and intakes of macro- and micronutrients will be calculated with the use of Dieta 5.0 software. On each visit Wingate ergocycling test will be performed, body composition will be measured and blood samples will be taken. The same day in the afternoon/evening hours the Fight Gone Bad (FGB) test will be performed. Body composition will be assessed based on air displacement plethysmography technology using the Bod Pod®. Moreover, total body water content will be analyzed by bioelectric impedance with the use of a BIA 101S analyzer. Anaerobic capacity will be assessed using the classical Wingate test on a cycloergometer. In order to assess CrossFit performance the FGB test will be performed. In blood samples the investigators plan to analyze concentrations of: lipoproteins and triglycerides (biochemical analyzer), betaine (LC-MS method), amino acid profile (LC-MS method), and testosterone (ELISA). MTHFR genotype will be analyzed with using a PCR-RFLP method. Data will be analyzed using the STATISTICA 12 software program.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 12, 2021
• Est. primary completion date: June 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• written informed consent from all participants before the study

• a current medical clearance to practice sports,

• training experience: at least 1 year (of CrossFit ttraining),

• minimum of 2 workout sessions (combat sport) a week,

Exclusion Criteria:

• current injury,

• any health-related contraindication,

• declared general feeling of being unwell,

• unwilling to follow the study protocol,

• serious disease or metabolic problems,

• intake of betaine, choline or creatine supplements 4 weeks before the beginning of the study.

Related Conditions & MeSH terms

• Sport
• Supplementation

Intervention

Dietary Supplement:
• Betaine supplementation
Group taking oral betaine supplementation
• Placebo treatment
Group taking oral supplementation with placebo (starch) in a similar capsule form.

Locations

Country	Name	City	State
Poland	Institute of Human Nutrition and Dietetics, Poznan University of Life Sciences	Poznan

Sponsors (2)

Lead Sponsor	Collaborator
Poznan University of Life Sciences	National Science Centre, Poland

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in fat mass and fat free mass after betaine supplementation	Fat mass (kg) and fat free mass (kg) analysis	Baseline and after 3 weeks
Primary	Changes in anaerobic capacity after betaine supplementation	The Wingate cycling test (W)	Baseline and after 3 weeks
Primary	Changes in specific performance capacity after betaine supplementation	The CrossFit-specific physical fitness test: Fight Gone Bad (reps.)	Baseline and after 3 weeks
Secondary	Changes in total body water after betaine supplementation	Total body water content (%)	Baseline and after 3 weeks
Secondary	Changes in testosterone level (ng/L) after betaine supplementation	Testosterone level (ng/L)	Baseline and after 3 weeks
Secondary	Changes in amino acid profile after betaine supplementation	Amino acid profile (µmol/L)	Baseline and after 3 weeks
Secondary	Changes in blood betaine	Blood betaine (µmol/L)	Baseline and after 3 weeks
Secondary	Changes in total, LDL and HDL cholesterol and triacylglycerol after betaine supplementation	Total, LDL and HDL cholesterol (mg/dL) and triacylglycerol (mg/dL)	Baseline and after 3 weeks
Secondary	Difference in response to betaine supplementation depending on MTHFR (rs1801133) polymorphism	MTHFR (rs1801133) polymorphism	Baseline and after 3 weeks