Tackling protein-energy under-nutrition among resource-limited people living with HIV/AIDS in Malawi using soybean-enriched maize-based stiff porridge (nsima): A pilot study.

AIM: The Ministry of Health in Malawi has scaled-up antiretroviral therapy (ART) for HIV infection. However, the majority of Malawians heavily depend on maize-based stiff porridge (nsima), a protein-deficient staple, a practice that exacerbates wasting and ultimately compromises the success of ART programming. This pilot study was conducted to evaluate the efficacy of utilising soybean-enriched nsima as a strategy for managing HIV-related wasting among resource-poor people. METHODS: A before and after designed study involving 25 wasted (<18.5 BMI (body mass index)) to normal (18.5-24.9 BMI) HIV-positive rural women (21-40 years) taking ART and provided with soybean-maize flour (20 kg/month for 3 months) prepared from hydrothermally treated soybeans and maize in the ratio of 1:4 (wt/wt). Anthropometry was performed at baseline and every month for the 3-month study period. Paired sample t-tests were used to test for changes in body mass and BMI between baseline and the subsequent months. RESULTS: Statistically significant (P < 0.001) cumulative mean weight gain for the first, second and third month of the study were 1.6, 2.1 and 2.9 kg, respectively. The number of participants with low BMI reduced from 6/25 at baseline to 2/25 after 3 months, and the mean BMI improved from 19.3 to 21.1 kg/m2 . CONCLUSIONS: Nsima prepared from a blend of maize and hydrothermally treated soybeans could feasibly be used to prevent and manage wasting among resource-poor people living with HIV/AIDS in sub-Saharan Africa who rely on maize as a major staple.

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

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.

From wasting to obesity, changes in nutritional concerns in HIV/AIDS.

Optimal nutrition is an important part of human immunodeficiency virus (HIV) care; to support the immune system, limit HIV-associated complications as well as maintain better quality of life and survival. The presentation and nature of malnutrition in patients with HIV has changed dramatically over the past 30 years from predominantly a wasting syndrome to lipodystrophy and, now, frailty. Nevertheless, we continue to see all 3 presentations in patient care today. The pathogenesis of poor nutrition in HIV-infected patients depends on caloric intake, intestinal nutrient absorption/translocation, and resting energy expenditure, which are features seen in all chronic diseases.

Development of a cross-over randomized trial method to determine the acceptability and safety of novel ready-to-use therapeutic foods.

OBJECTIVE: To develop a method for determining the acceptability and safety of ready-to-use therapeutic foods (RUTF) before clinical trialing. Acceptability was defined using a combination of three consumption, nine safety, and six preference criteria. These were used to compare a soy/maize/sorghum RUTF (SMS-RUTFh), designed for the rehabilitation of human immunodeficiency virus/tuberculosis (HIV/TB) wasted adults, with a peanut-butter/milk-powder paste (P-RUTF; brand: Plumpy'nut) designed for pediatric treatment. METHODS: A cross-over, randomized, controlled trial was conducted in Kenya. Ten days of repeated measures of product intake by 41 HIV/TB patients, >18 y old, body mass index (BMI) 18-24 kg · m(-2), 250 g were offered daily under direct observation as a replacement lunch meal. Consumption, comorbidity, and preferences were recorded. RESULTS: The study arms had similar age, sex, marital status, initial BMI, and middle upper-arm circumference. No carryover effect or serious adverse events were found. SMS-RUTFh energy intake was not statistically different from the control, when adjusted for BMI on day 1, and the presence of throat sores. General preference, taste, and sweetness scores were higher for SMS-RUTFh compared to the control (P < 0.05). Most consumption, safety, and preference criteria for SMS-RUTFh were satisfied except for the average number of days of nausea (0.16 versus 0.09 d) and vomiting (0.04 versus 0.02 d), which occurred with a higher frequency (P < 0.05). CONCLUSION: SMS-RUTFh appears to be acceptable and can be safely clinically trialed, if close monitoring of vomiting and nausea is included. The method reported here is a useful and feasible approach for testing the acceptability of ready-to-use foods in low income countries.

The benefit of supplementary feeding for wasted Malawian adults initiating ART.

Food insecurity is considered to be an important contributor to HIV associated wasting in sub-Saharan Africa. Low body mass index (BMI) is a strong risk factor for early mortality during antiretroviral therapy (ART). Nutritional supplementation has become standard of care in wasted patients starting ART in many countries in the region, but there is no unequivocal evidence base for this intervention. Against this background, we performed a retrospective study to compare food supplementation versus no nutritional intervention in wasted adults starting ART in Blantyre, Malawi. All patients received free nevirapine, lamivudine, and stavudine. Participants in an effectiveness trial of two food supplements received either corn-soy blend (CSB) or ready-to-use food spread (RUFS) during the first 14 weeks of ART. Results were compared with a historical control group receiving no food supplement that was part of an observational cohort study of outcomes of the same ART regimen. Characteristics on initiation of ART were similar in the three groups, except the use of cotrimoxazole prophylaxis which was more frequent in the food-supplemented groups. Linear regression analysis showed that increase in BMI was greatest in the RUFS group and better in the CSB group than in those receiving no food supplementation at 14 weeks. These differences were no longer significant at 26 weeks. Lower BMI, CD4 count and hemoglobin, WHO clinical stage IV, male gender, and not receiving cotrimoxazole prophylaxis were independent risk factors for mortality at 14 and 26 weeks in the logistic regression analysis. Supplementary food use was not directly associated with improved survival.

Supplementary feeding in the care of the wasted HIV infected patient.

Wasting and food insecurity are commonly seen in patients receiving antiretroviral treatment (ART) programs in sub-Saharan Africa and south Asia, and supplementary feeding is often offered in conjunction with ART. Evidence for the effectiveness of such supplementary feeding is scant. A randomised, investigator-blinded, controlled clinical trial of two types of supplementary food, corn/soy blended flour and a ready-to-use peanut butter-based lipid paste, in wasted adults in Blantyre, Malawi is described and the results summarised. A historical control group who did not receive supplementary food is described as well. Provision of about half of the daily energy requirement as a supplementary food for 14 weeks resulted in more rapid restoration of a normal BMI; and the energy-dense, ready-to-use paste was associated with more rapid weight gain than the blended flour. Survival was similar among the 3 groups. The strong association between lower BMI and survival indirectly suggests that there may well be clinical benefit from supplementary feeding in this population. No differences were seen in ART adherence or quality of life with more rapid restoration of BMI. Further research is urgently needed concerning the widespread practice of supplementary feeding in HIV/AIDS care to most effectively utilize this intervention.

Macronutrient supplementation for malnourished HIV-infected adults: a review of the evidence in resource-adequate and resource-constrained settings.

Access to antiretroviral therapy (ART) for human immunodeficiency virus (HIV) infection has expanded rapidly throughout sub-Saharan Africa, but malnutrition and food insecurity have emerged as major barriers to the success of ART programs. Protein-calorie malnutrition (a common form of malnutrition in the region) hastens HIV disease progression, and food insecurity is a barrier to medication adherence. Analyses of patient outcomes have identified a low body mass index after the start of ART as an independent predictor of early mortality, but the causes of a low body mass index are multifactorial (eg, normal anthropometric variation, chronic inadequate food intake, and/or wasting associated with HIV infection and other infectious diseases). Although there is much information on population-level humanitarian food assistance, few data exist to measure the effectiveness of macronutrient supplementation or to identify individuals most likely to benefit. In this report, we review the current evidence supporting macronutrient supplementation for HIV-infected adults, we report on clinical trials in resource-adequate and resource-constrained settings, and we highlight priority areas for future research.

Nutritional status of Malawian adults on antiretroviral therapy 1 year after supplementary feeding in the first 3 months of therapy.

OBJECTIVE: To test the hypothesis that individuals on antiretroviral therapy (ART) for 3 months with a greater body mass index (BMI) as a result of supplementary feeding with ready-to-use fortified spread would maintain a higher BMI 9 months after the feeding ended. METHODS: Two cohorts of wasted adults with AIDS, after 12 months of ART and 3 months of supplementary feeding with either ready-to-use fortified spread, an energy dense lipid paste; or corn/soy blended flour, were assessed for clinical and anthropometric status, quality of life, and ART adherence after 3 and 9 months. RESULTS: 336 ART patients participated: 162 who had received ready-to-use fortified spread and 174 who had received corn/soy blended flour. 9 months after stopping food supplements, both groups had a similar BMI, fat-free body mass, hospitalization rate and mortality. Binary logistic regression modelling showed that lower BMI, lower CD4 count, and older age at baseline were associated with a higher risk of death (odds ratio for BMI = 0.63, 95% CI 0.47-0.79). Adherence to the ART regimen and quality of life were similar in both cohorts. CONCLUSION: While supplementary feeding with ready-to-use fortified spread can ameliorate the BMI, an established risk factor for mortality, this effect is sustained only during the time of the intervention. Supplementary feeding of wasted patients for longer than 3 months should be investigated.

Supplementary feeding with either ready-to-use fortified spread or corn-soy blend in wasted adults starting antiretroviral therapy in Malawi: randomised, investigator blinded, controlled trial.

OBJECTIVE: To investigate the effect of two different food supplements on body mass index (BMI) in wasted Malawian adults with HIV who were starting antiretroviral therapy. DESIGN: Randomised, investigator blinded, controlled trial. SETTING: Large, public clinic associated with a referral hospital in Blantyre, Malawi. PARTICIPANTS: 491 adults with BMI <18.5. INTERVENTIONS: Ready-to-use fortified spread (n=245) or corn-soy blend (n=246). PRIMARY OUTCOMES: changes in BMI and fat-free body mass after 3.5 months. SECONDARY OUTCOMES: survival, CD4 count, HIV viral load, quality of life, and adherence to antiretroviral therapy. RESULTS: The mean BMI at enrolment was 16.5. After 14 weeks, patients receiving fortified spread had a greater increase in BMI and fat-free body mass than those receiving corn-soy blend: 2.2 (SD 1.9) v 1.7 (SD 1.6) (difference 0.5, 95% confidence interval 0.2 to 0.8), and 2.9 (SD 3.2) v 2.2 (SD 3.0) kg (difference 0.7 kg, 0.2 to 1.2 kg), respectively. The mortality rate was 27% for those receiving fortified spread and 26% for those receiving corn-soy blend. No significant differences in the CD4 count, HIV viral load, assessment of quality of life, or adherence to antiretroviral therapy were noted between the two groups. CONCLUSION: Supplementary feeding with fortified spread resulted in a greater increase in BMI and lean body mass than feeding with corn-soy blend. TRIAL REGISTRATION: Current Controlled Trials ISRCTN67515515.

Nutrition issues in chronic drug users living with HIV infection.

Human immunodeficiency virus (HIV) infection and chronic drug abuse both compromise nutritional status. For individuals with both disorders, the combined effects on wasting, the nutritional consequence that is most closely linked to mortality, appear to be synergistic. Substance abuse clinicians can improve and extend patients' lives by recommending healthy diets; observing and assessing for food insecurity, nutritional deficits, signs of weight loss and wasting, body composition changes, and metabolic abnormalities; and providing referrals to food programs and nutritionists. More studies are needed on the nutritional consequences of using specific illicit drugs, the impact on health of specific micronutrient and metabolic deficiencies seen in people with HIV, and the causes and clinical implications of body fat changes associated with HIV.

Nutritional and metabolic abnormalities in pre-AIDS HIV infection.

Since the earliest reports of human immunodeficiency virus (HIV) disease, undernutrition has been associated with HIV infection, typically with the late stages of the disease (namely acquired immunodeficiency syndrome), and may advance to severe wasting and cachexia. Specific micronutrient deficiencies are also recognized to occur with HIV infection, but their actual effect on the clinical course of the disease is hard to assess. The studies reviewed provide more insight into the complex interface between undernutrition and, in some cases, obesity and HIV/acquired immunodeficiency syndrome and highlight the possibility of alleviating or curing undernutrition by means of simple and comparatively inexpensive dietary adjustments.

A comparison of the clinical and cost-effectiveness of 3 intervention strategies for AIDS wasting.

OBJECTIVE: To compare oxandrolone (OX) or strength training with nutrition alone (NA) for AIDS wasting. SUBJECTS: Fifty patients with AIDS; 47 completing the study. INTERVENTIONS: Randomization to (1) NA with placebo pills, (2) nutrition with 10 mg of OX administered orally twice a day, or (3) nutrition with progressive resistance training (PRT) for 12 weeks. MAIN OUTCOME MEASURES: Midthigh cross-sectional muscle area (CSMA), physical functioning (PF), costs, and cost-effectiveness in dollars/quality-adjusted life-years (dollars/QALYs). RESULTS: The OX and PRT subjects had increases in CSMA (7.0% +/- 2.5%, P = 0.01; 5.0% +/- 2.0%, P = 0.04, respectively), although these increases did not differ significantly from the NA arm (NA: 1.0% +/- 1.0%; OX vs. NA: P = 0.09; PRT vs. NA: P = 0.26). Only PRT caused significant improvements in PF (mean +/- SE: 10.4 +/- 3.8 points on a 100-point scale) and 7 measures of strength (P values: 0.04 to <0.001). There were no overall differences between groups in PF change. Among patients with impaired baseline PF, however, OX was significantly less effective than NA and PRT was significantly better than NA. All treatments led to increases in protein intake and performance; NA and PRT also increased caloric intake. The institutional costs per subject in this trial were 983 dollars for NA, 3772 dollars for OX, and 3189 dollars for PRT. At a community-based level of intensity, the institutional costs per QALY were 45,000 dollars (range: 42,000 dollars-64,000 dollars) for NA, 147,000 dollars (range: 147,000 dollars-163,000 dollars) for OX, and 31,000 dollars (range: 21,000 dollars-44,000 dollars) for PRT. CONCLUSIONS: OX and PRT induce similar improvements in body composition, but PRT improves quality of life more than nutrition or OX, particularly among patients with impaired PF. PRT was the most cost-effective intervention, and OX was the least cost-effective intervention.

Nutritional aspects of HIV-infected children receiving highly active antiretroviral therapy.

The presentation of the nutritional problems of HIV-infected children is changing over time with improved antiretroviral regimens. Early reports of HIV infection in the 1980s, included such problems as malnutrition and wasting. However, as treatment and prophylactic regimens improve, the current nutritional problems of HIV-infected children in developed countries include truncal obesity and insulin resistance in addition to malnutrition. Background data on the wasting syndrome, etiology of malnutrition, nutritional effects of highly active antiretroviral therapies, and nutritional intervention strategies for HIV-infected children will be presented.

Nutritional supplementation according to energy and protein requirements in malnourished HIV-infected patients.

To evaluate the effects of nutritional supplements on nitrogen and energy balances, body composition and immune parameters, HIV-infected malnourished adult outpatients were prospectively studied. Forty-six patients (4 females and 42 males; 37 +/- 12 y) were supplemented with a polymeric diet (PD) or regular foods (RF) on two consecutive 45-day periods on a crossover design. Weight, skinfold thicknesses, plasma albumin (PA), CD4 and CD8 lymphocyte counts (LC), resting energy expenditure (REE) and urinary nitrogen excretion were measured at baseline, 45 and 90-day. Food intake was weekly recorded by food surveys. Thirty-five patients completed the protocol (18 in Group 1:PD-->RF; 17 in Group 2:RF-->PD). In both groups, weight, fat free mass (FFM), energy balance (EB) and nitrogen balance (NB) increased significantly after PD, whereas LC and PA remained unchanged in both groups. The best results in terms of weight gain were obtained in the PD group and PD plus zidovudine subgroup (n = 8) during the first 45 days (weight gain/FFM gain: 4.8/2.6 kg and 6.8/3.1 kg, respectively). Nutritional supplement with PD, according to the EB and NB goals, was well tolerated and permitted to achieve a significant weight and FFM gain over a 90-day follow-up.

Nutritional supplementation according to energy and protein requirements in malnourished HIV-infected patients

To evaluate the effects of nutritional supplements on nitrogen and energy balances, body composition and immune parameters, HIV-infected malnourished adult outpatients were prospectively studied. Forty-six patients (4 females and 42 males; 37 +/- 12 y) were supplemented with a polymeric diet (PD) or regular foods (RF) on two consecutive 45-day periods on a crossover design. Weight, skinfold thicknesses, plasma albumin (PA), CD4 and CD8 lymphocyte counts (LC), resting energy expenditure (REE) and urinary nitrogen excretion were measured at baseline, 45 and 90-day. Food intake was weekly recorded by food surveys. Thirty-five patients completed the protocol (18 in Group 1:PD-->RF; 17 in Group 2:RF-->PD). In both groups, weight, fat free mass (FFM), energy balance (EB) and nitrogen balance (NB) increased significantly after PD, whereas LC and PA remained unchanged in both groups. The best results in terms of weight gain were obtained in the PD group and PD plus zidovudine subgroup (n = 8) during the first 45 days (weight gain/FFM gain: 4.8/2.6 kg and 6.8/3.1 kg, respectively). Nutritional supplement with PD, according to the EB and NB goals, was well tolerated and permitted to achieve a significant weight and FFM gain over a 90-day follow-up.

Nutritional treatment for acquired immunodeficiency virus-associated wasting using beta-hydroxy beta-methylbutyrate, glutamine, and arginine: a randomized, double-blind, placebo-controlled study.

BACKGROUND: The current study was designed to examine whether a combination of three nutrients, consisting of beta-hydroxy-beta-methylbutyrate (HMB), a metabolite of leucine, L-glutamine (Gln) and L-arginine (Arg), each of which has been previously shown to slow muscle proteolysis, could synergistically alter the course of muscle wasting in patients with established acquired immunodeficiency syndrome (AIDS). METHODS: Sixty-eight human immunodeficiency virus (HIV)-infected patients with a documented weight loss of at least 5% in the previous 3 months were recruited from the HIV clinic at Nassau County Medical Center. The subjects were randomly assigned in a double-blind fashion to receive either placebo containing maltodextrin or the nutrient mixture (HMB/Arg/Gln) containing 3 g HMB, 14 g L-glutamine, and 14 g L-arginine given in two divided doses daily for 8 weeks. Body weights (BW) were recorded weekly and lean body mass (LBM) and fat mass (FM) were measured by air displacement plethysmography and by a single computerized tomography (CT) slice through the thigh at 0, 4, and 8 weeks. RESULTS: Forty-three subjects completed the 8-week protocol, (placebo, n = 21; HMB/Arg/Gln, n = 22). At 8 weeks, the subjects consuming the HMB/Arg/Gln mixture gained 3.0 +/- 0.5 kg of BW while those supplemented with the placebo gained 0.37 +/- 0.84 kg (p = .009). The BW gain in the HMB/Arg/Gln-treated subjects was predominantly LBM (2.55 +/- 0.75 kg) compared with the placebo-supplemented subjects who lost lean mass (-0.70 +/- 0.69 kg, p = .003). No significant change in FM gain was observed (0.43 +/- 0.83 kg for the group receiving HMB/Arg/Gln and 1.07 +/- 0.64 kg for the group receiving the placebo, p > .20). Similar percentage changes in muscle mass and fat mass were observed with CT scans. Immune status was also improved as evident by an increase in CD3 and CD8 cells and a decrease in the HIV viral load with HMB/Arg/Gln supplementation. CONCLUSIONS: The data indicate that the HMB/Arg/Gln mixture can markedly alter the course of lean tissue loss in patients with AIDS-associated wasting.

Evaluation and treatment of weight loss in adults with HIV disease.

Weight loss late in the course of human immunodeficiency virus (HIV) disease is common and often multifactorial. Increased energy expenditure in response to opportunistic disease, as well as to HIV infection itself, can lead to protein-calorie malnutrition similar to that observed in starvation. Weight loss of as little as 5 percent in patients with HIV infection is associated with an increased risk of disease progression. Loss of body cell mass carries a particularly poor prognosis, and aggressive measures should be taken to stop such depletion. Patients exhibiting unexpected weight loss should be carefully examined to exclude decreased food intake, malabsorption, occult infection or neoplasm as the etiology of the weight loss. Early aggressive treatment of HIV disease and underlying opportunistic pathology, along with adequate pharmacologic, hormonal, nutritional and physical therapy, can often restore normal weight and body composition.