A Study to Evaluate High Protein Supplementation in HIV-Positive Patients With Stable Weight Loss
- Conditions
- HIV InfectionsHIV Wasting Syndrome
- Registration Number
- NCT00000925
- Brief Summary
The purpose of this study is to determine whether a high-quality protein food supplement will help HIV-positive patients maintain, and possibly gain, muscle mass.
Many HIV-positive patients lose weight that they are then unable to regain. This may be because patients are not eating enough protein or are not eating the right kinds of protein. The protein eaten in foods (such as meat, eggs, or beans) may not be able to make up for the amount of protein lost due to HIV infection. This study gives patients high-quality protein food supplements to help them maintain and/or gain weight.
- Detailed Description
In many HIV-infected individuals with prior weight loss, the failure to regain weight and lean tissue is at least in part the consequence of inadequate protein intake or ingestion of a poor-quality protein rather than total caloric intake. Dietary sources of protein are presumably inadequate to meet the high metabolic needs caused by HIV infection. To achieve a target protein intake in the range (1.5 to 2.0 g/kg/day) demonstrated in other catabolic diseases necessary to achieve positive nitrogen balance and to generate substantial anabolic effects, this study will administer a supplement containing high-quality protein.
Two groups of 28 patients each are randomly chosen to receive either an oral nutritional supplement (Optimune) containing increased amounts of high-quality protein (whey), which is rich in cysteine and glutamine, or an isocaloric, identical-tasting supplement without added whey protein or amino acid supplementation. Weight, body composition, anthropometry, dietary intake, and general physical health are assessed at baseline and at Weeks 6 and 12. Plasma cysteine, glutathione, C-reactive protein, and prealbumin, along with urine IL-6, sTNFrII, and IL-1ra, are assessed at baseline and at Week 12.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 56
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (19)
Stanford Univ Med Ctr
🇺🇸Stanford, California, United States
Univ of Rochester Medical Center
🇺🇸Rochester, New York, United States
Julio Arroyo
🇺🇸West Columbia, South Carolina, United States
Univ of Colorado Health Sciences Ctr
🇺🇸Denver, Colorado, United States
Univ of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Univ of Washington
🇺🇸Seattle, Washington, United States
San Francisco Gen Hosp
🇺🇸San Francisco, California, United States
UCLA CARE Ctr
🇺🇸Los Angeles, California, United States
Johns Hopkins Hosp
🇺🇸Baltimore, Maryland, United States
Chelsea Ctr
🇺🇸New York, New York, United States
St Louis Regional Hosp / St Louis Regional Med Ctr
🇺🇸St Louis, Missouri, United States
Cornell Univ Med Ctr
🇺🇸New York, New York, United States
Univ of Southern California / LA County USC Med Ctr
🇺🇸Los Angeles, California, United States
Ohio State Univ Hosp Clinic
🇺🇸Columbus, Ohio, United States
Philadelphia Veterans Administration Med Ctr
🇺🇸Philadelphia, Pennsylvania, United States
Univ of Puerto Rico
🇵🇷San Juan, Puerto Rico
Queens Med Ctr
🇺🇸Honolulu, Hawaii, United States
Univ of Hawaii
🇺🇸Honolulu, Hawaii, United States
Tulane Univ School of Medicine
🇺🇸New Orleans, Louisiana, United States