Evaluation of High Protein Supplementation in HIV-1-Positive Subjects With Stable Weight Loss
Colección de datos
Enfermedades Transmisibles+13
+ Enfermedades Urogenitales
+ Infecciones Transmitidas por la Sangre
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de mayo de 1999
Fecha en la que se inscribió al primer participante.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.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 56 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.A partir de 18 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
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.
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene 19 ubicaciones
Univ of Southern California / LA County USC Med Ctr
Los Angeles, United StatesAbrir Univ of Southern California / LA County USC Med Ctr en Google MapsUCLA CARE Ctr
Los Angeles, United StatesSan Francisco Gen Hosp
San Francisco, United StatesStanford Univ Med Ctr
Stanford, United States