Effect of Fenugreek Use in Mothers of Preterm on Breast Milk Production and Macronutrient Content

NCT02384655 | Unknown Phase 1

• 1 other identifier: 0652-14-TLV-RM
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Feeding human milk to preterm infants does reduce the risk of serious and costly neonatal intensive care unit acquired morbidity such as NEC and the late onset sepsis. It is often difficult to obtain sufficient quantities of human milk from mothers of preterm infants most of whom are breast pump-dependent for weeks or months. Mothers will try to use galactogogues in an attempt to increase milk production. Fenugreek (Trigonella foenum-graecum) seeds is the most commonly used herbal galactogogue and is a member of the pea family. Our experience at the NICU is that around 30% of preterm mothers desperately looking for ways to increase their breast milk supply will eventually took fenugreek (Hilbe) as food supplement. Although widely recommended, there is limited evidence to support the effectiveness of fenugreek as a galactogogue. The aims of this study are to evaluate whether maternal consumption of fenugreek seeds has any effect on macronutrients composition of breast milk and whether fenugreek is transferred to the infant via mother milk. In addition any changes in mother and infant health status will be assessed.

Conditions

Preterms; Lactation

Keywords

Preterms; Breastfeeding; Lactation; Macronutrients

Outcome Measures

Primary Outcomes (1)

• Change in daily volume of expressed milk

  at day 0, 3, 7, 10, 14

Secondary Outcomes (1)

• Change in Macronutrient content analysis of breastmilk

  at day 0, 3, 7, 14

Study Arms (1)

Fenugreek

EXPERIMENTAL

Mothers will take fenugreek for 14 days

Drug: Fenugreek seed meal

Interventions

Fenugreek seed meal DRUG

3x3 capsules of fenugreek seeds per day for 14 days

Fenugreek

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy mothers 7 to 14 days postpartum,
• Mothers of preterm infants under 38 weeks of gestation,
• Mothers with poor milk supply documented by professional lactation consultants.

You may not qualify if:

• Mothers with mastitis,
• Mothers with breast engorgement,
• Mothers currently consuming Reglan, Domperidone or other drugs/herbals used to induce milk production,
• Mothers who are taking medications (Diuretics, Pseudoephedrine, - Anticholinergics, Warfarin or any anticoagulant, An estrogen-containing birth control pill),
• Mothers with Diabetes mellitus,
• Mothers who have had breast surgery that could alter milk synthesis or production,
• Mothers diagnosed with Polycystic Ovary Syndrome,
• Mothers diagnosed with Asthma or atopic disease,
• Mothers who are known to be allergic to peanuts or soybeans,
• Mothers whose milk supply per 24 hours exceeds 600 mL,
• Mothers with hypo/hyperthyroidism

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Department of Neonatology Tel Aviv Medical Center

Tel Aviv, 64239, Israel

RECRUITING

MeSH Terms

Conditions

Breast Feeding

Interventions

fenugreek seed meal

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Ronella Marom, MD

  Department of Neonatology, Lis Maternity Hospital, Tel Aviv Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ronella Marom, MD

CONTACT

+97236925690; ronellam@tlvmc.gov.il

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2015
• First Posted: March 10, 2015
• Study Start: March 11, 2015
• Primary Completion: June 1, 2021
• Study Completion: September 1, 2021
• Last Updated: June 17, 2020

Record last verified: 2020-06

Locations

IL (1)