BACKGROUND: Preliminary evidence suggests that improved nutrition early in HIV infection may delay progression to AIDS and delay the initiation or improve the effectiveness of antiretroviral drug therapy. There are few studies that evaluate food-based interventions in drug-naïve, HIV-infected women and their children. Meat provides several nutrients identified as important in maintaining immune function and lean body mass. OBJECTIVE: To design supplemental meat and soybean biscuits for use in a randomized trial examining the effect of meat in the diet of drug-naïve, HIV-infected rural Kenyan women on changes in weight, lean body mass, morbidity, nutritional status, and activities of daily living of the women and growth and development of their children. METHODS: We designed three supplemental biscuits: one with added dried beef another with added soybean flour, and a wheat biscuit to serve as a control biscuit to be used in a randomized feeding intervention in drug-naïve, HIV-infected rural Kenyan women and their children. The nutritional contents of the different types of biscuit were examined and compared. RESULTS: The three biscuits were isocaloric. Meat biscuits provided more lysine, vitamin B12, and bioavailable zinc. Soybean biscuits provided more total and absorbable iron; however, higher fiber and phytate contents may inhibit nutrient absorption. Data analysis for clinical outcomes of the trial is ongoing. CONCLUSIONS: The "biscuit model" is useful for nutrition supplementation studies because it can be provided in a blinded and randomized fashion, safely and privately in a home under directly observed consumption by a highly stigmatized population. It is well received by adults and children, and the biscuits can be produced locally with available, simple, affordable technology.
RCT Entities:
BACKGROUND: Preliminary evidence suggests that improved nutrition early in HIV infection may delay progression to AIDS and delay the initiation or improve the effectiveness of antiretroviral drug therapy. There are few studies that evaluate food-based interventions in drug-naïve, HIV-infectedwomen and their children. Meat provides several nutrients identified as important in maintaining immune function and lean body mass. OBJECTIVE: To design supplemental meat and soybean biscuits for use in a randomized trial examining the effect of meat in the diet of drug-naïve, HIV-infected rural Kenyanwomen on changes in weight, lean body mass, morbidity, nutritional status, and activities of daily living of the women and growth and development of their children. METHODS: We designed three supplemental biscuits: one with added dried beef another with added soybean flour, and a wheat biscuit to serve as a control biscuit to be used in a randomized feeding intervention in drug-naïve, HIV-infected rural Kenyanwomen and their children. The nutritional contents of the different types of biscuit were examined and compared. RESULTS: The three biscuits were isocaloric. Meat biscuits provided more lysine, vitamin B12, and bioavailable zinc. Soybean biscuits provided more total and absorbable iron; however, higher fiber and phytate contents may inhibit nutrient absorption. Data analysis for clinical outcomes of the trial is ongoing. CONCLUSIONS: The "biscuit model" is useful for nutrition supplementation studies because it can be provided in a blinded and randomized fashion, safely and privately in a home under directly observed consumption by a highly stigmatized population. It is well received by adults and children, and the biscuits can be produced locally with available, simple, affordable technology.