title: Effects of nutritional supplementation for HIV patients starting antiretroviral treatment: randomised controlled trial in Ethiopia.
abstract: OBJECTIVE
  To determine the effects of lipid based nutritional supplements with either whey or soy protein in patients with HIV during the first three months of antiretroviral treatment (ART) and to explore effects of timing by comparing supplementation at the start of ART and after three months delay.
  
  
  METHODS
  Randomised controlled trial.
  
  
  METHODS
  Three public ART facilities in Jimma, Oromia region, Ethiopia.
  
  
  METHODS
  Adults with HIV eligible for ART with body mass index (BMI) >16.
  
  
  METHODS
  Daily supplementation with 200 g (4600 kJ) of supplement containing whey or soy during either the first three or the subsequent three months of ART.
  
  
  METHODS
  Primary: lean body mass assessed with deuterium dilution, grip strength measured with dynamometers, and physical activity measured with accelerometer and heart rate monitors. Secondary: viral load and CD4 counts. Auxiliary: weight and CD3 and CD8 counts.
  
  
  RESULTS
  Of 318 patients enrolled, 210 (66%) were women, mean age was 33 (SD 9), and mean BMI was 19.5 (SD 2.4). At three months, participants receiving the supplements containing whey or soy had increased their lean body mass by 0.85 kg (95% confidence interval 0.16 kg to 1.53 kg) and 0.97 kg (0.29 kg to 1.64 kg), respectively, more than controls. This was accompanied by an increased gain of grip strength of 0.68 kg (-0.11 kg to 1.46 kg) for the whey supplement group and 0.93 kg (0.16 kg to 1.70 kg) for the soy supplement group. There were no effects on physical activity. Total weight gain increased by 2.05 kg (1.12 kg to 2.99 kg) and 2.06 kg (1.14 kg to 2.97 kg) for the whey and soy groups, respectively. In addition, in the whey supplement group overall CD3 counts improved by 150 cells/µL (24 to 275 cells/µL), of which 112 cells/µL (15 to 209 cells/µL) were CD8 and 25 cells/µL (-2 to 53 cells/µL) were CD4. Effects of the soy containing supplement on immune recovery were not significant. The effects of the two supplements, however, were not significantly different in direct comparison. Exploratory analysis showed that relatively more lean body mass was gained by patients with undetectable viral load at three months. Patients receiving delayed supplementation had higher weight gain but lower gains in functional outcomes.
  
  
  CONCLUSIONS
  Lipid based nutritional supplements improved gain of weight, lean body mass, and grip strength in patients with HIV starting ART. Supplements containing whey were associated with improved immune recovery. Trial registration Controlled-trials.com ISRCTN32453477.
authors.affiliation: Department of Nutrition, Exercise and Sports, University of Copenhagen, Rolighedsvej 30, 1958 Frederiksberg C, Denmark mette.frahm.olsen@gmail.com.
authors.forename: Mette F
authors.initials: MF
authors.lastname: Olsen
authors.affiliation: Department of Laboratory Sciences and Pathology, Jimma University, Jimma, Ethiopia.
authors.forename: Alemseged
authors.initials: A
authors.lastname: Abdissa
authors.affiliation: Department of Nutrition, Exercise and Sports, University of Copenhagen, Rolighedsvej 30, 1958 Frederiksberg C, Denmark.
authors.forename: Pernille
authors.initials: P
authors.lastname: Kæstel
authors.affiliation: Department of Psychiatry, College of Public Health and Medical Sciences, Jimma University, Jimma, Ethiopia.
authors.forename: Markos
authors.initials: M
authors.lastname: Tesfaye
authors.affiliation: Department of Internal Medicine, Jimma University Specialized Hospital, Jimma, Ethiopia.
authors.forename: Daniel
authors.initials: D
authors.lastname: Yilma
authors.affiliation: Department of Paediatric and Child Health, Jimma University Specialized Hospital, Jimma, Ethiopia.
authors.forename: Tsinuel
authors.initials: T
authors.lastname: Girma
authors.affiliation: Childhood Nutrition Research Centre, UCL Institute of Child Health, London, UK.
authors.forename: Jonathan C K
authors.initials: JC
authors.lastname: Wells
authors.affiliation: Department of Nutrition, Exercise and Sports, University of Copenhagen, Rolighedsvej 30, 1958 Frederiksberg C, Denmark.
authors.forename: Christian
authors.initials: C
authors.lastname: Ritz
authors.affiliation: Department of Nutrition, Exercise and Sports, University of Copenhagen, Rolighedsvej 30, 1958 Frederiksberg C, Denmark.
authors.forename: Christian
authors.initials: C
authors.lastname: Mølgaard
authors.affiliation: Department of Nutrition, Exercise and Sports, University of Copenhagen, Rolighedsvej 30, 1958 Frederiksberg C, Denmark.
authors.forename: Kim F
authors.initials: KF
authors.lastname: Michaelsen
authors.affiliation: Ethiopian Health and Nutrition Research Institute, Addis Ababa, Ethiopia.
authors.forename: Dilnesaw
authors.initials: D
authors.lastname: Zerfu
authors.affiliation: MRC Epidemiology Unit, University of Cambridge, Cambridge, UK.
authors.forename: Søren
authors.initials: S
authors.lastname: Brage
authors.affiliation: Department of Infectious Diseases, Odense University Hospital, Odense, Denmark.
authors.forename: Ase B
authors.initials: AB
authors.lastname: Andersen
authors.affiliation: Department of Nutrition, Exercise and Sports, University of Copenhagen, Rolighedsvej 30, 1958 Frederiksberg C, Denmark.
authors.forename: Henrik
authors.initials: H
authors.lastname: Friis
mesh_terms: D000293:Adolescent; D000328:Adult; D023241:Antiretroviral Therapy, Highly Active; D001823:Body Composition; D015992:Body Mass Index; D018791:CD4 Lymphocyte Count; D019587:Dietary Supplements; D005002:Ethiopia / Q000453:epidemiology; D005260:Female; D005500:Follow-Up Studies; D019247:HIV Wasting Syndrome / Q000178:diet therapy* / Q000401:mortality; D018737:Hand Strength; D006801:Humans; D008297:Male; D008875:Middle Aged; D008894:Milk Proteins / Q000008:administration & dosage*; D009043:Motor Activity; D030262:Soybean Proteins / Q000008:administration & dosage*; D016896:Treatment Outcome; D019562:Viral Load; D015430:Weight Gain; D000067816:Whey Proteins
chemical_list: D008894:Milk Proteins; D030262:Soybean Proteins; D000067816:Whey Proteins