Evaluation of High Protein Supplementation in HIV-1-Positive Subjects With Stable Weight Loss
Collecte de données
Infections transmises par le sang+16
+ Maladies génito-urinaires
+ Maladies Génitales
Étude thérapeutique
Résumé
Date de début de l'étude : 1 mai 1999
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.56 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Inclusion Criteria You may be eligible for this study if you: * Are HIV-positive. * Are at least 18 years old. * Have an HIV level less than 5,000 copies/ml within 30 days of study entry. * Have lost weight in the past year, but your weight has remained fairly stable in the 2 months prior to enrollment. * Are expected to live for at least 6 months. * Are usually able to eat enough to maintain your present weight. * Are able to complete a 3-day food diary. Exclusion Criteria You will not be eligible for this study if you: * Have gained a significant amount of weight in the past 2 months. * Have any opportunistic (HIV-associated) infections. * Are unable to eat enough food for any reason, or are on tube feeding. * Have nausea, diarrhea, or vomiting in the 14 days prior to study entry. * Are being treated for diabetes. * Are receiving chemotherapy or radiation therapy to treat cancer. * Are pregnant or breast-feeding. * Are allergic to milk or mangoes. * Have an implanted defibrillator.
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 19 sites
Univ of Southern California / LA County USC Med Ctr
Los Angeles, United StatesOuvrir Univ of Southern California / LA County USC Med Ctr dans Google MapsUCLA CARE Ctr
Los Angeles, United StatesSan Francisco Gen Hosp
San Francisco, United StatesStanford Univ Med Ctr
Stanford, United States