Moringa Supplementation for Improved Milk Output

NCT05333939 | Completed

• 1 other identifier: PED-22-MORINGA
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

The overall objective is to obtain preliminary data on the effect of Moringa oleifera leaf supplementation (moringa) at 4g daily for four weeks compared to placebo to improve human milk quantity and quality and infant health. Hypothesis: Four grams of moringa daily by mouth compared to placebo will increase breastmilk output and percent of mother's own milk consumed by infant.

Conditions

Breastfeeding

Keywords

maternal and child health

Outcome Measures

Primary Outcomes (1)

• Milk output

  24 hour milk output at 7 days

  7 days

Secondary Outcomes (1)

• % mother's own milk consumed by infant

  7 days

Study Arms (2)

Moringa

EXPERIMENTAL

4 g moringa leaf powder in green capsules divided into 4 capsules twice daily x 7 days

Dietary Supplement: Moringa leaf powder

Control

PLACEBO COMPARATOR

comparable weight green capsules with cornstarch divided into 4 capsules twice daily x 7 days

Other: Placebo

Interventions

Moringa leaf powder DIETARY_SUPPLEMENT

capsule ingestion

Also known as: moringa oleifera

Moringa

Placebo OTHER

capsule ingestion

Also known as: cornstarch

Control

Eligibility Criteria

• Age: 0 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Mom YES: * willing to breastfeed or pump for one week * willing to complete study activities (at minimum measure 24 hour pumped volume at start and end of capsules, take capsules daily, and answer questions) * has access to breastpump (in hospital and/or home) * English speaking * 18 years or older * Gave birth between 2-6 weeks prior to study start NO: * taking metoclopramide (trade name Reglan) currently or within 2 weeks of enrollment * taking moringa regularly or within 2 weeks of enrollment * breast surgery (amplification, reduction, or other) * breast condition: Insufficient Glandular tissue * unprescribed or street drug use at any point in pregnancy, or enrolled in rehab program or receiving addiction therapy * refuses to take 4 capsules twice daily within 2 days of study start * wishes to withdraw within 2 days of study start Infant YES: * 28-36 and 7 weeks gestation (ie 37 weeks is too old) * 2-6 weeks old * singleton birth NO: · any condition where breastmilk is clinically contraindicated

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Kentucky: lead
• University of Idaho: collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

MeSH Terms

Conditions

Breast Feeding

Interventions

flocculant protein MO 2.1, Moringa oleifera; Starch

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Polysaccharides

Study Officials

• Suzanna Attia, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: placebo controlled randomized controlled trial

Study Record Dates

• First Submitted: March 28, 2022
• First Posted: April 19, 2022
• Study Start: May 17, 2022
• Primary Completion: August 3, 2024
• Study Completion: August 3, 2024
• Last Updated: October 17, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)