Malnutrition
Conditions
Brief summary
Complementary food supplements (CFS), fortified products that are mixed with the infant's usual complementary foods, have the potential to improve nutrition among infants. In Africa, maize is a major staple food used for complementary feeding. Compared to rice or wheat, maize has higher levels of phytates, which bind trace elements such as iron and zinc, and inhibit their absorption. The impact of CFS products in the context of a maize-based diet has not been well investigated. This study will test two newly developed fat-based CFS products made from soy. The first product is a fortified fat-based spread that contains essential fatty acids with added docosahexaenoic acid (DHA) and arachidonic acid (ARA), and phytase to improve iron and zinc bioavailability. The second product is a fortified fat-based product containing essential fatty acids. Both products contain soy. The enrichment of the products with essential fatty acids is of particular interest in the South African context, as consumers are exposed to higher linoleic acid (LA) diets due to the inclusion of mostly high LA-containing sunflower oil during food preparation. The CFS products could contribute towards restoring the balance between LA and alpha-linolenic acid (ALA) intake. The results of this study will provide evidence on whether or not two types of fortified CFS have the potential to address malnutrition (linear growth) and improve psychomotor development in infants. If proven effective, this approach of providing multiple nutrients can be made available to infants in the developing world and may lead to sustainable actions.
Interventions
DIETARY_SUPPLEMENTFortified fat-based paste with essential fatty acids, DHA, ARA, phytase, L-lysine, potassium, phosphorous, magnesium and manganese
Complementary food supplement providing micronutrients, essential fatty acids, DHA and ARA, phytase, L-lysine, potassium, phosphorous, magnesium and manganese
DIETARY_SUPPLEMENTFortified fat-based paste with essential fatty acids
Complementary food supplement fortified with micronutrients and essential fatty acids
Sponsors
Global Alliance for Improved Nutrition
DSM Ltd
Unilever R&D
North-West University, South Africa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to 6 Months
Healthy volunteers
Yes
Inclusion criteria
* Infants resident in the study area * Aged 6 months
Exclusion criteria
* Severe obvious congenital abnormalities * Severe anaemia (haemoglobin \< 70 g/L) * Severe malnutrition (weight-for-length Z-score \<-3.00) * Other diseases referred for hospitalization by clinic staff * Plans to move out of the study area in the next 7 months * Known food allergies/intolerances e.g. to peanuts, milk and fish * Infants given special nutritional supplements * Infants known to be HIV+ * Not been borne as a singleton
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Linear growth by measuring length | 6 months | To assess the effects of two different fortified fat-based complementary food supplements on linear growth compared to a control |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Psychomotor-motor development measured by the Kilifi Developmental Inventory and Parent rating (gross motor skills) at baseline and end. Motor milestones chart (weekly) | 6 months | To investigate the effects of two different fortified fat-based complementary food supplements on psycho-motor development of infants compared to a control group. |
| Measures of anemia, essential fatty acid, iron and iodine status | 6 months | To investigate the effects of two different fortified fat-based complementary food supplements on anemia, essential fatty acid, iron and iodine status of infants compared to a control group. |
| Growth by measuring weight of infant (bi-monthly, mid-upper arm circumference (MUAC) and head circumference of infant (baseline and end) | 6 month | To assess the effects of two different fortified fat-based complementary food supplements on weight, MUAC and head circumference of infants |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety | 6 months | Safety will be assessed by recording (serious) adverse events \[(S)AEs\]. This is comprised in the Record Morbidity activity. Episodes of vomit, diarrheal, upper respiratory diseases, fever and rush will be weekly monitoring and recording. A morbidity questionnaire has been purposely developed. |
| Nutritional status of mothers/caregivers | 6 months | Mothers/caregivers height and weight, and a breast milk and urine sample of mothers will be taken at baseline as a reflection of their nutritional status. |
| Acceptability | 1 month | Acceptability of complementary food supplements will be assessed before the start of the intervention trial |
| Dietary assessment | 6 months | Multiple pass 24-hr recall (baseline and end) |
Countries
South Africa
Outcome results
None listed