An interventional study of Fortified fat-based paste with essential fatty acids, DHA, ARA, phytase, L-lysine, potassium, phosphorous, magnesium and manganese and Fortified fat-based paste with essential fatty acids in Malnutrition, sponsored by North-West University, South Africa. Completed at 1 site in South Africa. Open to participants aged 6 Months to 6 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-11-30.
Sponsored by North-West University, South Africa · Not applicable, Interventional, and Treatment
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.
1,587 studies on the registry are indexed under Malnutrition; 237 are open to participants now.
This study's enrollment of 750 is above the median of 90 across 1,134 interventional studies indexed under Malnutrition.
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Exclusion Criteria:
Complementary food supplement providing micronutrients and both essential fatty acids, DHA, ARA, phytase and L-lysine, potassium, phosphorous, magnesium and manganese
Dietary Supplement: Fortified fat-based paste with essential fatty acids, DHA, ARA, phytase, L-lysine, potassium, phosphorous, magnesium and manganese
Complementary food supplement providing micronutrients and essential fatty acids (EFAs)
Dietary Supplement: Fortified fat-based paste with essential fatty acids
The control group will receive a delayed intervention
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
Linear growth by measuring length
To assess the effects of two different fortified fat-based complementary food supplements on linear growth compared to a control
Time frame: 6 months
Psychomotor-motor development measured by the Kilifi Developmental Inventory and Parent rating (gross motor skills) at baseline and end. Motor milestones chart (weekly)
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
Measures of anemia, essential fatty acid, iron and iodine status
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 months
Growth by measuring weight of infant (bi-monthly, mid-upper arm circumference (MUAC) and head circumference of infant (baseline and end)
To assess the effects of two different fortified fat-based complementary food supplements on weight, MUAC and head circumference of infants
Time frame: 6 month
Safety
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
Nutritional status of mothers/caregivers
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: 6 months
Acceptability
Acceptability of complementary food supplements will be assessed before the start of the intervention trial
Time frame: 1 month
Dietary assessment
Multiple pass 24-hr recall (baseline and end)
Time frame: 6 months
This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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North-West University, South Africa