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Effects of Betaine Supplementation on Strength and Muscle Creatine Content

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ClinicalTrials.gov Identifier: NCT01213719
Recruitment Status : Completed
First Posted : October 4, 2010
Last Update Posted : January 16, 2012
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Healthy Subjects Dietary Supplement: creatine Dietary Supplement: betaine Dietary Supplement: dextrose Dietary Supplement: creatine plus betaine

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: Effects of Betaine Supplementation Combined or Not With Creatine Supplementation on Muscle Creatine Content and Strength
Study Start Date : October 2010
Primary Completion Date : July 2011
Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. strength [ Time Frame: after 10 days ]

Secondary Outcome Measures :
  1. intramuscular creatine content [ Time Frame: after 10 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • physically inactive
  • non-obese

Exclusion Criteria:

  • skeletal muscle disturbance
  • cardiovascular disturbance
  • use of dietary supplements
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01213719

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

Responsible Party: Bruno Gualano, Principal Investigator, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01213719     History of Changes
Other Study ID Numbers: betaine supplementation
First Posted: October 4, 2010    Key Record Dates
Last Update Posted: January 16, 2012
Last Verified: January 2012

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

Additional relevant MeSH terms:
Gastrointestinal Agents
Lipotropic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents