NCT01213719

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2010

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 4, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

January 16, 2012

Status Verified

January 1, 2012

Enrollment Period

9 months

First QC Date

October 1, 2010

Last Update Submit

January 12, 2012

Conditions

Healthy Subjects

Keywords

betaine, creatine, strength

Outcome Measures

Primary Outcomes (1)

  • strength

    after 10 days

Secondary Outcomes (1)

  • intramuscular creatine content

    after 10 days

Study Arms (4)

creatine

EXPERIMENTAL

will receive creatine monohydrate (20g/d) throughout 10 days

Dietary Supplement: creatine

betaine

EXPERIMENTAL

will receive betaine (2g/d) throughout 10 days

Dietary Supplement: betaine

placebo (dextrose)

PLACEBO COMPARATOR

will receive dextrose(20g/d)throughout 10 days.

Dietary Supplement: dextrose

creatine plus betaine

ACTIVE COMPARATOR

will receive creatine (20g/d) plus betaine (2g/d) throughout 10 days

Dietary Supplement: creatine plus betaine

Interventions

creatineDIETARY_SUPPLEMENT

20g/d throughout 10 days

creatine
betaineDIETARY_SUPPLEMENT

2g/d throughout 10 days

betaine
dextroseDIETARY_SUPPLEMENT

dextrose (placebo), 20 g/d throughout 10 days

placebo (dextrose)
creatine plus betaineDIETARY_SUPPLEMENT

creatine (20g/d) plus betaine (2g/d) throughout 10 days

creatine plus betaine

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • physically inactive
  • non-obese

You may not qualify if:

  • skeletal muscle disturbance
  • cardiovascular disturbance
  • use of dietary supplements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sao Paulo

São Paulo, São Paulo, 05508-030, Brazil

Location

MeSH Terms

Interventions

CreatineBetaineGlucose

Intervention Hierarchy (Ancestors)

GuanidinesAmidinesOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and ProteinsTrimethyl Ammonium CompoundsQuaternary Ammonium CompoundsAminesOnium CompoundsHexosesMonosaccharidesSugarsCarbohydrates

Study Officials

  • Bruno Gualano, PhD

    University of Sao Paulo

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 1, 2010

First Posted

October 4, 2010

Study Start

October 1, 2010

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

January 16, 2012

Record last verified: 2012-01

Locations

BR(1)