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

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 Overview

• Status: Completed
• Conditions: Malnutrition; Wasting; Growth Failure
• Intervention / Treatment: Dietary supplement: Moringa oleifera (high dose); Dietary supplement: Moringa oleifera (low dose); Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kenya
  • Kisumu, Kenya, 40102
    • Kombewa County Hospital
  • Kisumu, Kenya, 40105
    • Chulaimbo Sub- County Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lactating Mothers (Moringa); Lactating mothers.	Dietary supplement: Moringa oleifera (high dose); Mothers will receive 20 grams of moringa leaf powder in porridge consumed daily for three months.
Experimental: Breastfeeding Infants (Moringa); Breastfeeding infants from lactating mothers	Dietary supplement: Moringa oleifera (high dose); Mothers will receive 20 grams of moringa leaf powder in porridge consumed daily for three months.
Experimental: Children (Moringa); Children from 6-59 months of age.	Dietary supplement: Moringa oleifera (low dose); Children will receive 5-10 grams of moringa leaf powder in porridge consumed daily for three months.
Placebo Comparator: Lactating Mothers (placebo); Lactating mothers.	Dietary supplement: Placebo; Mothers and children will receive porridge with placebo.
Placebo Comparator: Breastfeeding Infants (placebo); Breastfeeding infants from lactating mothers	Dietary supplement: Placebo; Mothers and children will receive porridge with placebo.
Placebo Comparator: Children (placebo); Children from 6-59 months of age.	Dietary supplement: Placebo; Mothers and children will receive porridge with placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Body Weight	Body weight	at baseline and 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Vitamin A	Serum retinol binding protein will be used to survey vitamin A levels in infants at baseline and monthly to 3 months..	3 months
Change in Infant Height	Height (body length)	at baseline and 3 months
Change in Mid-Upper Arm Circumference	Mid-upper arm circumference (MUAC) will be measured at baseline and monthly to 3 months. Change from baseline to 3 months reported	baseline and 3 months
Change in CRP Levels	C-reactive protein (CRP) will be used to measure inflammation at baseline and monthly to 3 months. Change from baseline to 3 months reported. Negative values are considered a better outcome.	baseline and 3 months
Change in the Soluble Transferrin Receptor	The soluble transferrin receptor (sTFR) will be used to evaluate anemia at baseline and monthly to 3 months. Change from baseline to 3 months reported.	baseline and 3 months
Change in Fecal Neopterin	Fecal neopterin will be measured at baseline and at 3 months.	baseline and 3 months
Change in Fecal Myeloperoxidase	Fecal myeloperoxidase will be measured at baseline and at 3 months.	baseline and 3 months
Change in Alpha-1-Antitrypsin	Fecal alpha-1-antitrypsin will be measured at baseline and at 3 months.	baseline and 3 months
Change in the Prevalence of Diarrhea	Proportion of participants experiencing diarrhea (> 3 watery stools in 24 hours).	1 and 3 months
Change in Breastmilk Volume	Breastmilk volume will be assessed from 24 hour breast pumping or hand expression or weighing the infant before and after feeding for 24 hours.	at enrollment and at 3 months
Change in Breastmilk Vitamin A	Levels of vitamin A in breastmilk will be measured at the end of the study.	baseline and 3 months

Collaborators and Investigators

• Sponsor: Suzanna L Attia
• Collaborators: Fogarty International Center of the National Institute of Health
• Investigators: Principal Investigator: Suzanna L Attia, University Of Kentucky

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2021
• Primary Completion (Actual): September 4, 2022
• Study Completion (Actual): September 4, 2022

Study Registration Dates

• First Submitted: October 8, 2020
• First Submitted That Met QC Criteria: October 8, 2020
• First Posted (Actual): October 14, 2020

Study Record Updates

• Last Update Posted (Estimated): November 22, 2023
• Last Update Submitted That Met QC Criteria: October 31, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Moringa oleifera; supplementation
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition; Failure to Thrive
• Other Study ID Numbers: 58219; K01TW009987-06 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No