NCT04587271

Nutritional Impact of Moringa Oleifera Leaf Supplementation in Mothers and Children

Investigating the Impact of Moringa Oleifera Leaf Supplementation on Growth, Nutrition, Lactation, and Inflammation in Kenyan Breastfeeding Mothers and Children

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Suzanna L Attia · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Malnutrition
• Wasting
• Growth Failure

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Moringa oleifera (high dose)	Mothers will receive 20 grams of moringa leaf powder in porridge consumed daily for three months.
DIETARY_SUPPLEMENT	Moringa oleifera (low dose)	Children will receive 5-10 grams of moringa leaf powder in porridge consumed daily for three months.
DIETARY_SUPPLEMENT	Placebo	Mothers and children will receive porridge with placebo.

Timeline

• Start date: 2021-07-21
• Primary completion: 2022-09-04
• Completion: 2022-09-04
• First posted: 2020-10-14
• Last updated: 2023-11-22
• Results posted: 2023-11-22

Locations

2 sites across 1 country: Kenya