Clinical trial NCT00851591: Effect of Fenugreek on Milk Production
Official title: Effect of Fenugreek on Milk Production
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lactation
Keywords: fenugreek
galactogogue
breastmilk
Trigonella foenum-graecum
Bird's Foot
Greek Clover
Greek Hay
Hu Lu Ba
Trigonella
Lead sponsor: Texas Tech University Health Sciences Center
Sponsor class: OTHER
First posted: 2009-02-26
Enrollment: 3
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The Main Outcome Variable of This Study is the Quantity of Milk Produced.
timeFrame: "Day 0" , "Day 8"
Secondary outcomes:
measure: Secondary Outcome Variables Are to Include Milk-fat Content and Protein Content.
timeFrame: day 0; day 8
Other outcomes:
Locations:
city: Amarillo
country: United States
facility: Texas Tech University Health Sciences Center School of Medicine
state: Texas
Study officials:
affiliation: Texas Tech University Health Sciences Center
name: Thomas W Hale, PhD
role: STUDY_DIRECTOR
References:
citation: 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.