NCT01164020

Brief Summary

Resistance training as well as creatine supplementation may be beneficial for cognitive function, such as memory and attention. Therefore, the investigators speculate that resistance training combined with creatine supplementation would promote additive benefits on cognitive function in elderly women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2010

Typical duration 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

July 15, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 16, 2010

Completed
16 days until next milestone

Study Start

First participant enrolled

August 1, 2010

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

January 18, 2013

Status Verified

January 1, 2013

Enrollment Period

2.3 years

First QC Date

July 15, 2010

Last Update Submit

January 17, 2013

Conditions

CognitionAging

Keywords

cognitionsupplementation creatineresistance trainingaging

Outcome Measures

Primary Outcomes (1)

  • cognitive function

    six months

Secondary Outcomes (1)

  • physical capacity

    six months

Study Arms (4)

placebo control

PLACEBO COMPARATOR

this only receives placebo (dextrose)

Other: Placebo (Dextrose)

placebo and exercise

EXPERIMENTAL

this is trained and receives placebo

Other: Placebo (Dextrose)Other: Resistance training

creatine supplementation

EXPERIMENTAL

this is non-exercise trained and receives creatine supplementation

Dietary Supplement: creatine supplementation

Creatine and Exercise

EXPERIMENTAL

this is exercised trained and receives creatine supplementation

Dietary Supplement: creatine supplementationOther: Resistance training

Interventions

creatine supplementationDIETARY_SUPPLEMENT

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

Creatine and Exercisecreatine supplementation
Placebo (Dextrose)OTHER

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

placebo and exerciseplacebo control
Resistance trainingOTHER

resistance training twice a week for 24 weeks

Creatine and Exerciseplacebo and exercise

Eligibility Criteria

Age60 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • women older than 60 years old

You may not qualify if:

  • cardiovascular diseases or muscular disturbances precluding exercise training
  • drugs affecting the cognition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Medicine - Division of Rheumatology

São Paulo, São Paulo, 05508-030, Brazil

Location

Related Publications (1)

  • Alves CR, Merege Filho CA, Benatti FB, Brucki S, Pereira RM, de Sa Pinto AL, Lima FR, Roschel H, Gualano B. Creatine supplementation associated or not with strength training upon emotional and cognitive measures in older women: a randomized double-blind study. PLoS One. 2013 Oct 3;8(10):e76301. doi: 10.1371/journal.pone.0076301. eCollection 2013.

    PMID: 24098469DERIVED

MeSH Terms

Interventions

CreatineGlucoseResistance Training

Intervention Hierarchy (Ancestors)

GuanidinesAmidinesOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and ProteinsHexosesMonosaccharidesSugarsCarbohydratesExercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Bruno Gualano, PhD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

  • Antonio H Lancha Junior, PhD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 15, 2010

First Posted

July 16, 2010

Study Start

August 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

January 18, 2013

Record last verified: 2013-01

Locations

BR(1)