Effect of Fenugreek on Milk Production

NCT ID: NCT00851591

Last Updated: 2018-06-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2012-08-31

Brief Summary

Each year, approximately 3 million mothers in the USA alone leave the hospital breastfeeding an infant. However, a large number discontinue breastfeeding, because milk synthesis is poor or simply stops. Termed "Insufficient Milk Syndrome," this condition probably accounts for approximately 5-10% of the total population of breastfeeding mothers and includes many mothers with premature infants, mothers with polycystic ovary syndrome, and a myriad of other unknown causes. The mother's inability to breastfeed causes enormous feelings of inadequacy, grief, depression, and other problems, not to mention increased health risks to the infant.

The most popular herbal remedy used around the world for increasing milk synthesis is fenugreek. Fenugreek (Trigonella foenum graecum) is a seed product from the legume family that is commonly sold, since the dried, ripe seed and extracts are used as an artificial flavor for maple syrup. When used orally in amounts commonly found in foods, it has been granted Generally Recognized as Safe (GRAS) status in the USA by the FDA. Although it is used by millions of women around the world to increase their milk supply, we have only one small case report which suggested it might actually increase the milk supply.

In this one study, the authors found an approximate 40% increase in milk production, although the study was not blinded, nor did they use a control population. For these reasons, we still do not know with certainty if fenugreek works as a galactagogue.

This study is designed to accurately determine if seven days of fenugreek will stimulate milk production in a selected group of subjects with poor milk supply. We hypothesize that the women enrolled in the test group will have increased milk production at the end of the 8-day study.

Detailed Description

This study is designed to accurately determine if seven days of fenugreek will stimulate milk production in a selected group of subjects with poor milk supply. We hypothesize that the women enrolled in the test group will have increased milk production at the end of the 8-day study.

Conditions

Lactation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Fenugreek category 1

receive fenugreek

Group Type: EXPERIMENTAL

fenugreek

Intervention Type: DRUG

3 capsules 3 times per day with a full glass of water each dose for 7 days

Placebo Category 2

receive placebo

Group Type: PLACEBO_COMPARATOR

Placebo (Psyllium)

Intervention Type: DRUG

3 capsules 3 times a day with a full glass of water each dose for 7 days

Interventions

fenugreek

3 capsules 3 times per day with a full glass of water each dose for 7 days

Intervention Type: DRUG

Placebo (Psyllium)

3 capsules 3 times a day with a full glass of water each dose for 7 days

Intervention Type: DRUG

Other Intervention Names

Trigonella foenum-graecum, Alhova, Bird's Foot, Greek Clover; Metamucil®,; Hydrocil Instant®,; Modane Bulk Powder®

Eligibility Criteria

Inclusion Criteria

• Mothers 2-12 weeks postpartum
• Mothers with term infants 37 weeks gestation or older
• Mothers with poor milk supply documented by professional lactation consultants
• Mothers whose milk supply is less than 600 cc per 24 hours
• Mothers who agree not to breastfeed or provide their milk to their infants during this study

Exclusion Criteria

• Mothers with documented mastitis
• Mothers with breast engorgement
• Mothers with inverted nipples
• Maternal BMI greater than 35
• Mothers currently consuming Reglan, Domperidone or other drugs/herbals used to induce milk production
• Mothers who are clinically ill or hospitalized, or taking the following medications:

1. Diuretics

2. Pseudoephedrine

3. Anticholinergics

4. Warfarin or any anticoagulant

5. 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 with tubular breasts or breasts with insufficient glandular tissue
• Mothers diagnosed with Asthma or atopic disease
• Mothers who are known to be allergic to peanuts or soybeans
• Mothers who are pregnant
• Mothers whose milk supply per 24 hours exceeds 600 mL
• Mothers with Obstetrical evaluation recommending exclusion

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Texas Tech University Health Sciences Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas W Hale, PhD

Role: STUDY_DIRECTOR

Texas Tech University Health Sciences Center

Locations

Texas Tech University Health Sciences Center School of Medicine

Amarillo, Texas, United States

Countries

United States

References

Foong SC, Tan ML, Foong WC, Marasco LA, Ho JJ, Ong JH. Oral galactagogues (natural therapies or drugs) for increasing breast milk production in mothers of non-hospitalised term infants. Cochrane Database Syst Rev. 2020 May 18;5(5):CD011505. doi: 10.1002/14651858.CD011505.pub2.

Reference Type: DERIVED

PMID: 32421208 (View on PubMed)

Other Identifiers

A08-3479

Identifier Type: -

Identifier Source: org_study_id