Evaluation of high-protein supplementation in weight-stable HIV-positive subjects with a history of weight loss: a randomized, double-blind, multicenter trial.

BACKGROUND HIV patients with wasting are at increased risk of opportunistic complications and fatality. OBJECTIVE We hypothesized that augmenting dietary intake with high-biologic-value protein would enhance weight and lean tissue in weight-stable subjects with a prior unintentional weight loss of >3%. DESIGN Fifty-nine subjects with HIV RNA concentrations <5000 copies/mL were randomly assigned to receive a 280-kcal supplement containing 40 g whey protein or a matched isocaloric control supplement without added protein twice daily for 12 wk. RESULTS Before the study, intake of total energy and protein exceeded estimated requirements (44.3 +/- 12.6 kcal x kg(-1) x d(-1) and 1.69 +/- 0.55 g x kg(-1) x d(-1), respectively). Both supplements failed to increase total energy intake because of decreases in self-selected food intake. Changes in weight (0.8 +/- 2.4 and 0.7 +/- 2.4 kg) and lean body mass (0.3 +/- 1.4 and 0.3 +/- 1.5 kg) did not differ significantly between the whey protein and control groups, respectively. Waist-to-hip ratio improved more with whey protein (-0.02 +/- 0.05) than with the control (0.01 +/- 0.03; P = 0.025) at week 6 but not at week 12. Fasting triacylglycerol increased by 39 +/- 98 mg/dL with the control supplement and decreased by 16 +/- 62 mg/dL with whey protein at week 12 (P = 0.03). CD4 lymphocytes increased by 31 +/- 84 cells/mm(3) with whey protein and decreased by 5 +/- 124 cells/mm(3) with the control supplement at 12 wk (P = 0.03). Gastrointestinal symptoms occurred more often with whey protein. CONCLUSIONS A whey protein supplement did not increase weight or lean body mass in HIV-positive subjects who were eating adequately, but it did increase CD4 cell counts. The control supplement with rapidly assimilable carbohydrate substituted for protein increased cardiovascular disease risk factors. Careful dietary and weight history should be obtained before starting nutritional supplements in subjects with stable weight loss and good viral control.

[1]  C. Gibert,et al.  Weight loss as a predictor of survival and disease progression in HIV infection. Terry Beirn Community Programs for Clinical Research on AIDS. , 1998, Journal of acquired immune deficiency syndromes and human retrovirology : official publication of the International Retrovirology Association.

[2]  R. Buhl,et al.  Effects of long-term supplementation with whey proteins on plasma glutathione levels of HIV-infected patients , 2002, European journal of nutrition.

[3]  O. Kirk,et al.  Cardiovascular disease risk factors in HIV patients – association with antiretroviral therapy. Results from the DAD study , 2003, AIDS.

[4]  G. Beall,et al.  Long-term effects of early nutritional support with new enterotropic peptide-based formula vs. standard enteral formula in HIV-infected patients: randomized prospective trial. , 1993, Nutrition.

[5]  J. Kinney,et al.  Effects of increasing nitrogen intake on nitrogen balance and energy expenditure in nutritionally depleted adult patients receiving parenteral nutrition. , 1983, The American journal of clinical nutrition.

[6]  Battegay,et al.  Nutritional supplements combined with dietary counselling diminish whole body protein catabolism in HIV‐infected patients , 2000, European journal of clinical investigation.

[7]  C. Chastang,et al.  Efficacy of 2‐month total parenteral nutrition in AIDS patients: a controlled randomized prospective trial , 1996, AIDS.

[8]  J. Ward,et al.  Surveillance for AIDS-defining opportunistic illnesses, 1992-1997. , 1999, MMWR. CDC surveillance summaries : Morbidity and mortality weekly report. CDC surveillance summaries.

[9]  J. Currier,et al.  Effect of nandrolone decanoate therapy on weight and lean body mass in HIV-infected women with weight loss: a randomized, double-blind, placebo-controlled, multicenter trial. , 2005, Archives of internal medicine.

[10]  M. Roederer,et al.  Glutathione deficiency is associated with impaired survival in HIV disease. , 1997, Proceedings of the National Academy of Sciences of the United States of America.

[11]  J. Wang,et al.  Effect of home total parenteral nutrition on body composition in patients with acquired immunodeficiency syndrome. , 1990, JPEN. Journal of parenteral and enteral nutrition.

[12]  S. Heymsfield,et al.  Enteral alimentation and repletion of body cell mass in malnourished patients with acquired immunodeficiency syndrome. , 1991, The American journal of clinical nutrition.

[13]  S Burastero,et al.  Prediction of body cell mass, fat-free mass, and total body water with bioelectrical impedance analysis: effects of race, sex, and disease. , 1996, The American journal of clinical nutrition.

[14]  C. Gibert,et al.  Randomized, controlled trial of caloric supplements in HIV infection , 1999 .

[15]  M. McNurlan,et al.  Whole-body protein turnover from leucine kinetics and the response to nutrition in human immunodeficiency virus infection. , 1995, The American journal of clinical nutrition.

[16]  R. D'Agostino,et al.  Prediction of coronary heart disease risk in HIV-infected patients with fat redistribution. , 2003, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[17]  J. Kinney,et al.  Changes in nitrogen balance of depleted patients with increasing infusions of glucose. , 1979, The American journal of clinical nutrition.

[18]  J. Currier,et al.  Predictive markers of HIV-related weight loss and determination of differences between populations with weight loss stratified by opportunistic processes. , 1999, Journal of acquired immune deficiency syndromes.

[19]  J. Bartlett Weight loss and wasting in patients infected with human immunodeficiency virus , 2004 .

[20]  D. Wheeler,et al.  Protein intake is positively associated with body cell mass in weight-stable HIV-infected men. , 2003, The Journal of nutrition.

[21]  A. Folsom,et al.  Risk Factors for Ischemic Stroke Subtypes: The Atherosclerosis Risk in Communities Study , 2006, Stroke.

[22]  J. Pivarnik,et al.  A randomized, placebo-controlled trial of combined insulin-like growth factor I and low dose growth hormone therapy for wasting associated with human immunodeficiency virus infection. , 1996, The Journal of clinical endocrinology and metabolism.

[23]  S. Baruchel,et al.  Whey proteins as a food supplement in HIV-seropositive individuals. , 1993, Clinical and investigative medicine. Medecine clinique et experimentale.

[24]  R. Yolken,et al.  Effect of Enteral Tube Feeding on Growth of Children with Symptomatic Human Immunodeficiency Virus Infection , 1994, Journal of pediatric gastroenterology and nutrition.

[25]  Iftikhar J. Kullo,et al.  Progression of Subclinical Coronary Atherosclerosis: Does Obesity Make a Difference? , 2005, Circulation.

[26]  D. Spiegelman,et al.  The effect of protease inhibitors on weight and body composition in HIV‐infected patients , 1998, AIDS.

[27]  D. Wilmore,et al.  Glutamine-antioxidant supplementation increases body cell mass in AIDS patients with weight loss: a randomized, double-blind controlled trial. , 1999, Nutrition.

[28]  S. Heymsfield,et al.  Effects of whey protein and resistance exercise on body cell mass, muscle strength, and quality of life in women with HIV , 2001, AIDS.

[29]  J. Kinney,et al.  Parenteral nutrition in septic patients: effect of increasing nitrogen intake. , 1987, The American journal of clinical nutrition.

[30]  C. Mullany,et al.  Glucose Requirements Following Burn Injury: Parameters of Optimal Glucose Infusion and Possible Hepatic and Respiratory Abnormalities Following Excessive Glucose Intake , 1979, Annals of surgery.

[31]  C. Pichard,et al.  A randomized double-blind controlled study of 6 months of oral nutritional supplementation with arginine and omega-3 fatty acids in HIV-infected patients. Swiss HIV Cohort Study. , 1998, AIDS.

[32]  T. Miller,et al.  Gastrostomy tube supplementation for HIV-infected children. , 1995, Pediatrics.

[33]  R. A. Forse,et al.  High-energy, high-protein, oral, liquid, nutrition supplementation in patients with HIV infection: effect on weight status in relation to incidence of secondary infection. , 1996, Journal of the American Dietetic Association.

[34]  F. Sattler,et al.  Levels of HIV RNA are quantitatively related to prior weight loss in HIV-associated wasting. , 1998, Journal of acquired immune deficiency syndromes and human retrovirology : official publication of the International Retrovirology Association.

[35]  J. Williamson,et al.  AIDS wasting syndrome: trends, influence on opportunistic infections, and survival. , 2003, Journal of acquired immune deficiency syndromes.

[36]  A. A. Toro,et al.  Features of whey protein concentrate supplementation in children with rapidly progressive HIV infection. , 2006, Journal of tropical pediatrics.

[37]  D. McMillan,et al.  Effect of increased protein intake and nutritional status on whole-body protein metabolism of AIDS patients with weight loss. , 1995, Metabolism: clinical and experimental.

[38]  O. Izaola,et al.  Nutritional treatment for acquired immunodeficiency virus infection using an enterotropic peptide-based formula enriched with n-3 fatty acids: a randomized prospective trial , 2001, European Journal of Clinical Nutrition.

[39]  M. H. Murphy,et al.  Impact of the nutritional regimen on protein catabolism and nitrogen balance in patients with acute renal failure. , 1996, JPEN. Journal of parenteral and enteral nutrition.

[40]  C. Shikuma,et al.  Changes in weight and lean body mass during highly active antiretroviral therapy. , 2004, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[41]  G. Williams,et al.  Correlation between the glucose clamp technique and the homeostasis model assessment in hypertension. , 2001, American journal of hypertension.

[42]  F. Carrat,et al.  Effect of indinavir on HIV‐related wasting , 1998, AIDS.

[43]  J. Mirtallo,et al.  Parenteral nutrition for marrow transplant recipients: evaluation of an increased nitrogen dose. , 1991, JPEN. Journal of parenteral and enteral nutrition.

[44]  S. Gorbach,et al.  Weight loss and wasting remain common complications in individuals infected with human immunodeficiency virus in the era of highly active antiretroviral therapy. , 2000, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[45]  D A Follmann,et al.  The Journal of Clinical Endocrinology & Metabolism Printed in U.S.A. Copyright © 2000 by The Endocrine Society Quantitative Insulin Sensitivity Check Index: A Simple, Accurate Method for Assessing Insulin Sensitivity In Humans , 2022 .

[46]  A. Dobs,et al.  Changes in the incidence and predictors of wasting syndrome related to human immunodeficiency virus infection, 1987-1999. , 2002, American journal of epidemiology.

[47]  M. Cappell,et al.  A multicenter case-controlled study of percutaneous endoscopic gastrostomy in HIV-seropositive patients. , 1993, The American journal of gastroenterology.

[48]  G. Beall,et al.  Dietary intake and counseling, weight maintenance, and the course of HIV infection. , 1995, Journal of the American Dietetic Association.

[49]  D. Spiegelman,et al.  Increasing Risk of 5% or Greater Unintentional Weight Loss in a Cohort of HIV-Infected Patients, 1995 to 2003 , 2005, Journal of acquired immune deficiency syndromes.

[50]  R. Parker,et al.  Mixed Patterns of Changes in Central and Peripheral Fat Following Initiation of Antiretroviral Therapy in a Randomized Trial , 2006, Journal of acquired immune deficiency syndromes.

[51]  C. Gibert,et al.  Randomized, controlled trial of caloric supplements in HIV infection. Terry Beirn Community Programs for Clinical Research on AIDS. , 1999, Journal of acquired immune deficiency syndromes.

[52]  P. Singer,et al.  Clinical and immunologic effects of lipid-based parenteral nutrition in AIDS. , 1992, JPEN. Journal of parenteral and enteral nutrition.

[53]  L. Rabeneck,et al.  A randomized controlled trial evaluating nutrition counseling with or without oral supplementation in malnourished HIV-infected patients. , 1998, Journal of the American Dietetic Association.