Effect of Fenugreek on Milk Production

Lactation Clinical Trial

— fenugreek  

Official title:

Effect of Fenugreek on Milk Production

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00851591
• Other study ID #: A08-3479
• Status: Terminated
• Phase: N/A
• Start date: September 2008
• Est. completion date: August 2012

Study information

• Verified date: May 2018
• Source: Texas Tech University Health Sciences Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Lactation

Intervention

Drug:
• fenugreek
3 capsules 3 times per day with a full glass of water each dose for 7 days
• Placebo (Psyllium)
3 capsules 3 times a day with a full glass of water each dose for 7 days

Locations

Country	Name	City	State
United States	Texas Tech University Health Sciences Center School of Medicine	Amarillo	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Tech University Health Sciences Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Secondary Outcome Variables Are to Include Milk-fat Content and Protein Content.	Milk-fat content was not measured in these samples as we had decided to close the study.; Protein content was not measured in these samples as we had decided to close the study.	day 0; day 8