Betaine Effect in Speed-strength Athletes

September 15, 2020 updated by: Poznan University of Life Sciences

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Poland
      • Poznań, Poland, 60-624
        • Recruiting
        • Institute of Human Nutrition and Dietetics, Poznan University of Life Sciences
        • Contact:
        • Principal Investigator:
          • Emilia Zawieja, MSc
        • Principal Investigator:
          • Krzysztof Durkalec-Michalski, PhD
        • Principal Investigator:
          • Agata Chmurzyńska, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Betaine supplementation
The experimental procedure for each athlete includes a 3-week betaine supplementation either 2.5 g or 5 g daily. Betaine will be administered in the form of capsules containing either 0.5 or 1 g betaine. The capsules will be ingested with at least 250 mL of water. Each athlete will ingest 5 betaine capsules a day. On training days the supplements will be taken in the morning (2 capsules), in the evening (2 capsules) and 1.5 hours before training session (1 capsule). On rest days the supplements will be taken in the morning (2 capsules), in the afternoon (1 capsule) and in the evening (2 capsules).
Dietary supplement: Betaine supplementation
Group taking oral betaine supplementation
Dietary supplement: Placebo treatment
Group taking oral supplementation with placebo (starch) in a similar capsule form.
Experimental: Placebo treatment
The experimental procedure for each athlete included a 3-week placebo administration. Placebo will be capsules with starch. Placebo will be ingested with at least 250 mL of water. Each athlete will ingest 5 placebo capsules a day. On training days the supplements will be taken in the morning (2 capsules), in the evening (2 capsules) and 1.5 hours before training session (1 capsule). On rest days the supplements will be taken in the morning (2 capsules), in the afternoon (1 capsule) and in the evening (2 capsules).
Dietary supplement: Betaine supplementation
Group taking oral betaine supplementation
Dietary supplement: Placebo treatment
Group taking oral supplementation with placebo (starch) in a similar capsule form.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in fat mass and fat free mass after betaine supplementation
Time Frame: Baseline and after 3 weeks
Fat mass (kg) and fat free mass (kg) analysis
Baseline and after 3 weeks
Changes in anaerobic capacity after betaine supplementation
Time Frame: Baseline and after 3 weeks
The Wingate cycling test (W)
Baseline and after 3 weeks
Changes in specific performance capacity after betaine supplementation
Time Frame: Baseline and after 3 weeks
The CrossFit-specific physical fitness test: Fight Gone Bad (reps.)
Baseline and after 3 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in total body water after betaine supplementation
Time Frame: Baseline and after 3 weeks
Total body water content (%)
Baseline and after 3 weeks
Changes in testosterone level (ng/L) after betaine supplementation
Time Frame: Baseline and after 3 weeks
Testosterone level (ng/L)
Baseline and after 3 weeks
Changes in amino acid profile after betaine supplementation
Time Frame: Baseline and after 3 weeks
Amino acid profile (μmol/L)
Baseline and after 3 weeks
Changes in blood betaine
Time Frame: Baseline and after 3 weeks
Blood betaine (µmol/L)
Baseline and after 3 weeks
Changes in total, LDL and HDL cholesterol and triacylglycerol after betaine supplementation
Time Frame: Baseline and after 3 weeks
Total, LDL and HDL cholesterol (mg/dL) and triacylglycerol (mg/dL)
Baseline and after 3 weeks
Difference in response to betaine supplementation depending on MTHFR (rs1801133) polymorphism
Time Frame: Baseline and after 3 weeks
MTHFR (rs1801133) polymorphism
Baseline and after 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Poznan University of Life Sciences

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Science Centre, Poland

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Agata Chmurzyńska, Professor, Institute of Human Nutrition and Dietetics, Poznan University of Life Sciences, Poznan, Poland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 20, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 12, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 8, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 8, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 10, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 16, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ULS00005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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