Effects of nutritional supplementation for HIV patients starting antiretroviral treatment: randomised controlled trial in Ethiopia

Abstract

Objectives 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.Design Randomised controlled trial.Setting Three public ART facilities in Jimma, Oromia region, Ethiopia.Participants Adults with HIV eligible for ART with body mass index (BMI) >16.Intervention 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.Outcome measures 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.

The effect of nutritional supplementation on quality of life in people living with HIV: a randomised controlled trial

“…As part of the primary analysis of this study, we found that supplementation had an effect on weight gain . The association between low health‐related quality of life and low BMI among PLHIV in low‐income settings has been reported previously .…”

Lipid‐based nutrient supplements do not affect efavirenz but lower plasma nevirapine concentrations in Ethiopian adult HIV patients

“…As only trough concentrations were measured in the present study, effects on peak concentration cannot be ruled out. The finding that LNS did not affect the plasma trough concentration of EFV, the most commonly prescribed NNRTI, is promising, in view of the many beneficial effects of LNS, for example increased BMI, lean mass and grip strength, and improved immune recovery .…”

“…The study was part of a randomized trial comparing the effects of two LNSs with no‐LNS group given to HIV patients initiating ART. The study design is further described elsewhere and is illustrated in Figure . Briefly, participants received 200 g of an LNS developed by Nutriset (Malaunay, France) containing whey (LNS/w) or soy protein (LNS/s) for 3 months.…”

“…The study was part of a randomized trial comparing the effects of two LNSs with no-LNS group given to HIV patients initiating ART. The study design is further described elsewhere [13] and is illustrated in Figure 1 [1,4] or soy protein (LNS/s) [2,5] for 3 months. The patients were randomized to receive the nutritional intervention either at the time of enrolment or 3 months later [3] (the 'deferred' group).…”

The impact of nutritional status and nutrition supplementation on outcomes along the HIV treatment cascade in the resource-limited setting

“…The effects of supplementation were considerable, resulting in a more than threefold weight gain compared with the effects of starting ART alone and with substantially more lean body mass gained. Supplementation improved grip strength but had no significant effects on physical activity [23].…”