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Effects of Creatine and Resistance Exercise Training in People With HIV Infection

Primary Purpose

HIV Infections

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Use of creatine monohydrate (a dietary supplement)

Progressive resistance exercise training

About this trial

This is an interventional supportive care trial for HIV Infections focused on measuring Exercise, HIV, Creatine, Muscle

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Clinically stable, sedentary HIV-positive adults who are on optimized antiretroviral regimens and plan to remain so during the study.
Men and women on hormone replacement therapy and women using hormonal contraceptives must have been on stable regimens for the preceding 6 months and plan to continue on such treatment throughout the study period.

Exclusion Criteria:

Serum creatinine > 1.5 mg/dl or clinical evidence of renal disease or prior kidney transplant
Creatine kinase (CK) > 1.5 times the upper limit of normal (ULN)
Hemoglobin < 8.5 g/dl
AST, ALT, or LDH > 5 X ULN
Uncontrolled diarrhea (> 6 stools per day)
Impaired oral intake
Persistent nausea or vomiting
Untreated hypogonadism
Pharmacologic use of growth hormone, testosterone, oxandrolone, nandrolone decanoate, oxymetholone, or other oral, injectable, or transdermal anabolic steroids, androstenedione, or dehydroepiandrosterone (DHEA) within the preceding 6 months (subjects with documented hypogonadism on stable testosterone replacement, defined as a dose < 300 mg q2 weeks for the preceding 6 months, will be allowed to enroll)
Use of glucocorticoids, megestrol acetate, creatine monohydrate, cytokine inhibitors (thalidomide, pentoxifylline, ketotifen), drugs known to adversely affect renal function, cytokines, parenteral or tube feeding, or initiation of treatment for a systemic infection within 30 days prior to enrollment
History of angina, coronary heart disease, or congestive heart failure
Current pregnancy or lactation or plans to become pregnant.
Because vegetarians are known to have lower intramuscular concentrations of creatine and therefore may experience a much greater relative increase in muscle creatine levels, we will exclude such individuals from this study.

Sites / Locations

San Francisco General Hospital

Outcomes

Primary Outcome Measures

Muscle strength

Secondary Outcome Measures

Muscle size

Muscle energetics

Body composition

Biochemistries

Safety

Full Information

NCT ID

NCT00484627

First Posted

June 8, 2007

Last Updated

June 8, 2007

Sponsor

National Center for Complementary and Integrative Health (NCCIH)

1. Study Identification

Unique Protocol Identification Number

NCT00484627

Brief Title

Effects of Creatine and Resistance Exercise Training in People With HIV Infection

Official Title

Ergogenic Effects of Creatine Supplementation in HIV Infection

Study Type

Interventional

2. Study Status

Record Verification Date

June 2007

Overall Recruitment Status

Completed

Study Start Date

August 2001 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

October 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study was designed determine whether use of creatine monohydrate, a dietary supplement, can increase skeletal muscle mass and strength and improve the response to progressive resistance exercise training in people with HIV infection.

Detailed Description

This is a randomized, placebo-controlled study to evaluate the effect of creatine monohydrate, a dietary supplement, on skeletal muscle size and function (i.e., strength, energy metabolism, work capacity, fatigue); whole-body exercise performance; and body composition. This study is also designed to determine whether creatine supplementation augments the functional benefit derived from progressive resistance exercise. The safety of creatine supplementation in people with HIV infection will also be evaluated. Forty HIV-positive subjects will be randomly assigned, on a 1:1 basis, to receive creatine monohydrate or placebo for a period of 14 days, followed by a 12-week program of supervised progressive resistance exercise training during which administration of creatine monohydrate or placebo will continue. Measurements of muscle strength, size, composition, energetics and fatigue, as well as body weight and composition and serum biochemistries, will be made at baseline, after two weeks of treatment with creatine or placebo (before PRT), and again after 12 weeks of PRT (study week 14). Safety will be monitored throughout the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

Keywords

Exercise, HIV, Creatine, Muscle

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

43 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Use of creatine monohydrate (a dietary supplement)

Intervention Type

Behavioral

Intervention Name(s)

Progressive resistance exercise training

Primary Outcome Measure Information:

Title

Muscle strength

Time Frame

14 weeks

Secondary Outcome Measure Information:

Title

Muscle size

Time Frame

14 weeks

Title

Muscle energetics

Time Frame

14 weeks

Title

Body composition

Time Frame

14 weeks

Title

Biochemistries

Time Frame

14 weeks

Title

Safety

Time Frame

Throughout the study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Clinically stable, sedentary HIV-positive adults who are on optimized antiretroviral regimens and plan to remain so during the study. Men and women on hormone replacement therapy and women using hormonal contraceptives must have been on stable regimens for the preceding 6 months and plan to continue on such treatment throughout the study period. Exclusion Criteria: Serum creatinine > 1.5 mg/dl or clinical evidence of renal disease or prior kidney transplant Creatine kinase (CK) > 1.5 times the upper limit of normal (ULN) Hemoglobin < 8.5 g/dl AST, ALT, or LDH > 5 X ULN Uncontrolled diarrhea (> 6 stools per day) Impaired oral intake Persistent nausea or vomiting Untreated hypogonadism Pharmacologic use of growth hormone, testosterone, oxandrolone, nandrolone decanoate, oxymetholone, or other oral, injectable, or transdermal anabolic steroids, androstenedione, or dehydroepiandrosterone (DHEA) within the preceding 6 months (subjects with documented hypogonadism on stable testosterone replacement, defined as a dose < 300 mg q2 weeks for the preceding 6 months, will be allowed to enroll) Use of glucocorticoids, megestrol acetate, creatine monohydrate, cytokine inhibitors (thalidomide, pentoxifylline, ketotifen), drugs known to adversely affect renal function, cytokines, parenteral or tube feeding, or initiation of treatment for a systemic infection within 30 days prior to enrollment History of angina, coronary heart disease, or congestive heart failure Current pregnancy or lactation or plans to become pregnant. Because vegetarians are known to have lower intramuscular concentrations of creatine and therefore may experience a much greater relative increase in muscle creatine levels, we will exclude such individuals from this study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Morris Schambelan, MD

Organizational Affiliation

University of California, San Francisco; San Francisco General Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Kathleen Mulligan, PhD

Organizational Affiliation

University of California, San Francisco; San Francisco General Hospital

Official's Role

Study Director

Facility Information:

Facility Name

San Francisco General Hospital

City

San Francisco

State/Province

California

ZIP/Postal Code

94110

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

19242554

Citation

Sakkas GK, Mulligan K, Dasilva M, Doyle JW, Khatami H, Schleich T, Kent-Braun JA, Schambelan M. Creatine fails to augment the benefits from resistance training in patients with HIV infection: a randomized, double-blind, placebo-controlled study. PLoS One. 2009;4(2):e4605. doi: 10.1371/journal.pone.0004605. Epub 2009 Feb 26.

Results Reference

derived

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Effects of Creatine and Resistance Exercise Training in People With HIV Infection

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