A Study to Evaluate High Protein Supplementation in HIV-Positive Patients With Stable Weight Loss
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|ClinicalTrials.gov Identifier: NCT00000925|
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : July 29, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections HIV Wasting Syndrome||Drug: Optimune oral nutritional supplement||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||56 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Evaluation of High Protein Supplementation in HIV-1-Positive Subjects With Stable Weight Loss|
|Study Start Date :||May 1999|
|Actual Primary Completion Date :||June 2003|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000925
|Study Chair:||Kathleen Mulligan, MD|
|Study Chair:||Bruce R. Bistrian, MD|
|Study Chair:||Fred R. Sattler, MD|