Effects of Creatine and Resistance Exercise Training in People With HIV Infection
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Procedure: Use of creatine monohydrate (a dietary supplement) Behavioral: Progressive resistance exercise training |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Supportive Care |
| Official Title: | Ergogenic Effects of Creatine Supplementation in HIV Infection |
- Muscle strength [ Time Frame: 14 weeks ]
- Muscle size [ Time Frame: 14 weeks ]
- Muscle energetics [ Time Frame: 14 weeks ]
- Body composition [ Time Frame: 14 weeks ]
- Biochemistries [ Time Frame: 14 weeks ]
- Safety [ Time Frame: Throughout the study ]
| Enrollment: | 43 |
| Study Start Date: | August 2001 |
| Study Completion Date: | October 2003 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| United States, California | |
| San Francisco General Hospital | |
| San Francisco, California, United States, 94110 | |
| 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 |
More Information
No publications provided by National Center for Complementary and Alternative Medicine (NCCAM)
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00484627 History of Changes |
| Other Study ID Numbers: | R01 AT000491-01 |
| Study First Received: | June 8, 2007 |
| Last Updated: | June 8, 2007 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
|
Exercise HIV Creatine Muscle |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
ClinicalTrials.gov processed this record on June 18, 2013