Effect of Fenugreek on Milk Production

NCT00851591 | Terminated Results DMC

• 1 other identifier: A08-3479
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Lactation

Keywords

fenugreek; galactogogue; breastmilk; Trigonella foenum-graecum; Bird's Foot; Greek Clover; Greek Hay; Hu Lu Ba; Trigonella

Outcome Measures

Primary Outcomes (1)

• The Main Outcome Variable of This Study is the Quantity of Milk Produced.

  The single value of this variable was calculated average from day 0 and day 8.

  "Day 0" , "Day 8"

Secondary Outcomes (1)

• Secondary Outcome Variables Are to Include Milk-fat Content and Protein Content.

  day 0; day 8

Study Arms (2)

Fenugreek category 1

EXPERIMENTAL

receive fenugreek

Drug: fenugreek

Placebo Category 2

PLACEBO COMPARATOR

receive placebo

Drug: Placebo (Psyllium)

Interventions

fenugreek DRUG

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

Also known as: Trigonella foenum-graecum, Alhova, Bird's Foot, Greek Clover

Fenugreek category 1

Placebo (Psyllium) DRUG

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

Also known as: Metamucil®,, Hydrocil Instant®,, Modane Bulk Powder®

Placebo Category 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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 with tubular breasts or breasts with insufficient glandular tissue

Sponsors & Collaborators

• Texas Tech University Health Sciences Center: lead

Study Sites (1)

Texas Tech University Health Sciences Center School of Medicine

Amarillo, Texas, 79106, United States

Location

Related Publications (1)

• 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.

  PMID: 32421208 DERIVED

MeSH Terms

Conditions

Breast Feeding

Interventions

fenugreek seed meal; Psyllium

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Thomas Hale, PhD.
• Organization: Texas Tech University Health Sciences Center

thomas.hale@ttuhsc.edu

806-354-5528

Study Officials

• Thomas W Hale, PhD

  Texas Tech University Health Sciences Center

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2009
• First Posted: February 26, 2009
• Study Start: September 1, 2008
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: June 26, 2018
• Results First Posted: July 28, 2014

Record last verified: 2018-05

Locations

US (1)