Creatine Supplementation and Bone Mass

NCT ID: NCT01163370

Last Updated: 2011-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2011-08-31

Brief Summary

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Resistance training as well as creatine supplementation may increase bone mass. Therefore, the investigators speculate that resistance training combined with creatine supplementation would promote additive benefits on bone mass in elderly women with osteopenia and osteoporosis.

Detailed Description

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Conditions

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Osteopenia Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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control and exercise

this is trained and receives placebo

Group Type PLACEBO_COMPARATOR

exercise training

Intervention Type OTHER

resistance training twice a week for 24 weeks

placebo (dextrose)

Intervention Type OTHER

20g/d for 7 days followed by 5g/d for 23 weeks

creatine

this is non-exercise trained and receives creatine supplementation

Group Type EXPERIMENTAL

creatine supplementation

Intervention Type DIETARY_SUPPLEMENT

20g/d for 7 days followed by 5g/d for 23 weeks

exercise and creatine

this is exercised trained and receives creatine supplementation

Group Type EXPERIMENTAL

creatine supplementation

Intervention Type DIETARY_SUPPLEMENT

20g/d for 7 days followed by 5g/d for 23 weeks

exercise training

Intervention Type OTHER

resistance training twice a week for 24 weeks

placebo

this only receives placebo (dextrose)

Group Type PLACEBO_COMPARATOR

placebo (dextrose)

Intervention Type OTHER

20g/d for 7 days followed by 5g/d for 23 weeks

Interventions

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creatine supplementation

20g/d for 7 days followed by 5g/d for 23 weeks

Intervention Type DIETARY_SUPPLEMENT

exercise training

resistance training twice a week for 24 weeks

Intervention Type OTHER

placebo (dextrose)

20g/d for 7 days followed by 5g/d for 23 weeks

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* osteopenia and osteoporosis
* women older than 60 years old

Exclusion Criteria

* cardiovascular diseases or muscular disturbances precluding exercise training
* drugs affecting bone metabolism
Minimum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Bruno Gualano

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rosa MR Pereira, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Bruno Gualano, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

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School of Medicine - Division of Rheumatology

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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creatine and bone

Identifier Type: -

Identifier Source: org_study_id