Effect of Fenugreek on Milk Production (fenugreek)
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|ClinicalTrials.gov Identifier: NCT00851591|
Recruitment Status : Terminated (Low enrollment; investigator chose not to continue study)
First Posted : February 26, 2009
Results First Posted : July 28, 2014
Last Update Posted : June 26, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Lactation||Drug: fenugreek Drug: Placebo (Psyllium)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Effect of Fenugreek on Milk Production|
|Study Start Date :||September 2008|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||August 2012|
Experimental: Fenugreek category 1
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
Placebo Comparator: Placebo Category 2
Drug: Placebo (Psyllium)
3 capsules 3 times a day with a full glass of water each dose for 7 days
- The Main Outcome Variable of This Study is the Quantity of Milk Produced. [ Time Frame: "Day 0" , "Day 8" ]The single value of this variable was calculated average from day 0 and day 8.
- Secondary Outcome Variables Are to Include Milk-fat Content and Protein Content. [ Time Frame: day 0; day 8 ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00851591
|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|