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

Sponsor

National Center for Complementary and Integrative Health (NCCIH) (NIH)

Overall Status

Completed

CT.gov ID

NCT00484627

Collaborator

(none)

Enrollment

Location

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Procedure: Use of creatine monohydrate (a dietary supplement) Behavioral: Progressive resistance exercise training	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

43 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Supportive Care

Official Title:

Ergogenic Effects of Creatine Supplementation in HIV Infection

Study Start Date :

Aug 1, 2001

Actual Study Completion Date :

Oct 1, 2003

Outcome Measures

Primary Outcome Measures

Muscle strength [14 weeks]

Secondary Outcome Measures

Muscle size [14 weeks]
Muscle energetics [14 weeks]
Body composition [14 weeks]
Biochemistries [14 weeks]
Safety [Throughout the study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	San Francisco General Hospital	San Francisco	California	United States	94110

Sponsors and Collaborators

National Center for Complementary and Integrative Health (NCCIH)

Investigators

Principal Investigator: Morris Schambelan, MD, University of California, San Francisco; San Francisco General Hospital
Study Director: Kathleen Mulligan, PhD, University of California, San Francisco; San Francisco General Hospital