Investigating the Impact of Moringa Oleifera Leaf Supplementation on Growth, Nutrition, Lactation, and Inflammation in Kenyan Breastfeeding Mothers and Children
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Suzanna L Attia
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Change in Body Weight
Overview
Brief Summary
Studies to date on the effects of Moringa oleifera in diabetes and anemia and animal studies that examine the utility of moringa for increased milk and litter yield are of small scale, however high-quality large-scale placebo or case-controlled clinical trials to define the impact on infants of moringa leaf powder consumption by breastfeeding mothers are lacking. Moringa has a traditional and agricultural history of use as a galactagogue; despite this and its incorporation into products such as Mother's Milk Tea© and placement on NIH LactMed Lactation Database, this property has not been studied in large clinical trials nor in populations dependent on breastmilk such as in Kisumu, Kenya. This study will improve and add to existing knowledge of moringa's effect on human breastmilk and will provide novel information on the effect of moringa supplementation to lactating mothers on their infant's intestinal inflammation and health. After trial registration, the study was modified to include infant follow up to 18 months for some measures and the children's groups were removed. Although the study was modified to an 18 month follow up, the data were not able to be collected.
Further understanding of the acceptability of moringa leaf in a staple food of porridge and more the effect of moringa supplementation on infant and childhood growth, nutrition, and intestinal and systemic inflammation may translate in the future to the cultivation of moringa at the community or household level as an effective resource for the improvement of childhood undernutrition.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •lactating women at least 18 years of age and their exclusively breastfed infants within 14 days of delivery.
- •children 6-59 months of age who eat food
Exclusion Criteria
- •regular maternal consumption of moringa
- •receipt and consumption of food supplementation program
- •inability to feed orally or refusal to eat moringa or placebo porridge
- •for infants, prematurity (\<36 weeks gestational age)
- •for infants, significant congenital disease
- •for infants, inability to feed orally
Outcomes
Primary Outcomes
Change in Body Weight
Time Frame: at baseline and 3 months
Body weight
Secondary Outcomes
- Change in the Soluble Transferrin Receptor(baseline and 3 months)
- Change in Mid-Upper Arm Circumference(baseline and 3 months)
- Change in Alpha-1-Antitrypsin(baseline and 3 months)
- Change in Breastmilk Volume(at enrollment and at 3 months)
- Change in Fecal Neopterin(baseline and 3 months)
- Change in the Prevalence of Diarrhea(1 and 3 months)
- Change in Fecal Myeloperoxidase(baseline and 3 months)
- Change in Breastmilk Vitamin A(baseline and 3 months)
- Change in Vitamin A(3 months)
- Change in Infant Height(at baseline and 3 months)
- Change in CRP Levels(baseline and 3 months)
Investigators
Suzanna L Attia
Assistant Professor
University of Kentucky