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Effects of Betaine Supplementation on Strength and Muscle Creatine Content

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bruno Gualano, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01213719
First received: October 1, 2010
Last updated: January 12, 2012
Last verified: January 2012
History of Changes
  Purpose

It has been suggested that betaine supplementation may improve muscle strength by increasing muscle creatine content. However, there is no data supporting this assumption. The investigators speculate that betaine supplementation could enhance intramuscular creatine content, which would result in strength improvements.


Condition Intervention
Healthy Subjects
 Dietary Supplement: creatine
Dietary Supplement: betaine
Dietary Supplement: dextrose
Dietary Supplement: creatine plus betaine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Effects of Betaine Supplementation Combined or Not With Creatine Supplementation on Muscle Creatine Content and Strength

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • strength [ Time Frame: after 10 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • intramuscular creatine content [ Time Frame: after 10 days ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: October 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: creatine
will receive creatine monohydrate (20g/d) throughout 10 days
 Dietary Supplement: creatine
20g/d throughout 10 days
Experimental: betaine
will receive betaine (2g/d) throughout 10 days
 Dietary Supplement: betaine
2g/d throughout 10 days
Placebo Comparator: placebo (dextrose)
will receive dextrose(20g/d)throughout 10 days.
 Dietary Supplement: dextrose
dextrose (placebo), 20 g/d throughout 10 days
Active Comparator: creatine plus betaine
will receive creatine (20g/d) plus betaine (2g/d) throughout 10 days
 Dietary Supplement: creatine plus betaine
creatine (20g/d) plus betaine (2g/d) throughout 10 days

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • physically inactive
  • non-obese

Exclusion Criteria:

  • skeletal muscle disturbance
  • cardiovascular disturbance
  • use of dietary supplements
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01213719

Locations
Brazil
University of Sao Paulo
Sao Paulo, Brazil, 05508-030
Sponsors and Collaborators
University of Sao Paulo
Investigators
Study Director: Bruno Gualano, PhD University of Sao Paulo
  More Information

No publications provided

Responsible Party: Bruno Gualano, Principal Investigator, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01213719     History of Changes
Other Study ID Numbers: betaine supplementation
Study First Received: October 1, 2010
Last Updated: January 12, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
betaine, creatine, strength

Additional relevant MeSH terms:
Betaine
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Lipotropic Agents
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents

ClinicalTrials.gov processed this record on June 13, 2013