Jouberton area of the greater Matlosana Municipality
Jouberton, North West, South Africa
NCT Number: NCT01845610
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.
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Notify Me6 month–6 month
All sexes
Interventional
Not applicable
Jouberton, North West, South Africa
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Complementary food supplement providing micronutrients, essential fatty acids, DHA and ARA, phytase, L-lysine, potassium, phosphorous, magnesium and manganese
Complementary food supplement fortified with micronutrients and essential fatty acids
Time frame: 6 months
To assess the effects of two different fortified fat-based complementary food supplements on linear growth compared to a control
Time frame: 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.
Time frame: 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.
Time frame: 6 month
To assess the effects of two different fortified fat-based complementary food supplements on weight, MUAC and head circumference of infants
Time frame: 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.
Time frame: 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.
Time frame: 1 month
Acceptability of complementary food supplements will be assessed before the start of the intervention trial
Time frame: 6 months
Multiple pass 24-hr recall (baseline and end)
North-West University, South Africa
Other
Acronym: TSWAKA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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