A pilot study assessing the impact of a fortified supplementary food on the health and well-being of crèche children and adult TB patients in South Africa.

The South African population faces many of the global concerns relating to micronutrient deficiency and the impact this has on health and well-being. Moreover, there is a high prevalence of HIV infection, compounded by a high level of co-infection with TB.This pilot study evaluates the impact of a fortified supplementary food on the health and well-being of a cohort of crèche children, aged 3 to 6, and adult TB patients drawn from the Presidential Node of Alexandra, Johannesburg, South Africa. A further aim of this study was to evaluate the sensitivity and validity of non-invasive indicators of nutritional status in a field-based population sample.The investigational product, e'Pap, is supported by extensive anecdotal evidence that whole grain cereals with food-style nutrients constitute an effective supplementary food for those suffering from the effects of food insecurity, poor health and well-being, and coping with TB and HIV infection.The results indicate a beneficial effect of e'Pap for both study populations, and particularly for adult TB patients, whose baseline data reflected severe food insecurity and malnutrition in the majority of cases. There is evidence to suggest statistically significant improvements in key micronutrient levels, well-being and energy, hand-grip strength, the Bioelectrical Impedance Analysis (BIA) Illness Marker, and certain clinical indicators. Although Body Mass Index (BMI) and Mid Upper Arm Circumference (MUAC) are frequently used as standard measures to evaluate the efficacy of nutritional interventions, these indicators were not sufficiently sensitive in this study. Nor does weight gain necessarily indicate improved nutritional status. Hand-grip strength, lean body mass, and the BIA Illness Marker seem to be more useful indicators of change in nutritional status

Illness Marker.

<p>Illness Marker.</p

Child Lean Body Mass.

<p>Child Lean Body Mass.</p

Child Anthropometry.

<p>Note: BMI = Body Mass Index; MUAC = Mid Upper Arm Circumference</p

Adult Biochemistry.

<p>Normal Values: Selenium 46–143 µg/L; Albumin 35–52 g/L; Iron 10.3–30.9 mmol/L; Vitamin A 1.05–2.80 mmol/L;</p><p>Vitamin D 49–172 nmol/L; Zinc 8.2–23 mmol/L</p

Adult % General Well Being.

<p>Adult % General Well Being.</p

Adult Anthropometry.

<p>Note: BMI = Body Mass Index</p

Mean Hand-grip Strength.

<p>Mean Hand-grip Strength.</p

Losses to Follow Up.

<p>Losses to Follow Up.</p

Child Biochemistry.

<p>Normal Values: Selenium 46–143 µg/L; Albumin 38–54 g/L; Iron 9.0–21.5 mmol/L; Vitamin A 0.7–1.5 mmol/L;</p