Effect of Fenugreek on Milk Production (fenugreek)
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 gracen) 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 GRAS status in the USA by the FDA (Generally Recognized as Safe). 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Effect of Fenugreek on Milk Production|
- The main outcome variable of this study will be the quantity of milk produced. [ Time Frame: day 0; day 8 ] [ Designated as safety issue: No ]
- Secondary outcome variables will include milk-fat content and protein content. [ Time Frame: day 0; day 8 ] [ Designated as safety issue: No ]
|Study Start Date:||September 2008|
|Study Completion Date:||August 2012|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
3 capsules 3 times per day with a full glass of water each dose for 7 days
Other Name: Trigonella foenum-graecum, Alhova, Bird's Foot, Greek Clover, Greek Hay, Hu Lu Ba, Methi, Trigonella
Placebo Comparator: 2
3 capsules 3 times a day with a full glass of water each dose for 7 days
Other Name: Metamucil®, Fiberall®, Hydrocil Instant®, Konsyl®, Modane Bulk Powder®, Perdiem Fiber®, Serutan®, Siblan®
|United States, Texas|
|Texas Tech University Health Sciences Center School of Medicine|
|Amarillo, Texas, United States, 79106|
|Study Director:||Thomas W Hale, PhD||Texas Tech University Health Sciences Center|