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Effect of Fenugreek on Milk Production (fenugreek)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Texas Tech University Health Sciences Center

Tracking Information
First Submitted Date  ICMJE February 24, 2009
First Posted Date  ICMJE February 26, 2009
Results First Submitted Date  ICMJE January 24, 2014
Results First Posted Date  ICMJE July 28, 2014
Last Update Posted Date June 26, 2018
Study Start Date  ICMJE September 2008
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 31, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 25, 2009)
The main outcome variable of this study will be the quantity of milk produced. [ Time Frame: day 0; day 8 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 31, 2018)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 25, 2009)
Secondary outcome variables will include milk-fat content and protein content. [ Time Frame: day 0; day 8 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Fenugreek on Milk Production
Official Title  ICMJE Effect of Fenugreek on Milk Production
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Lactation
Intervention  ICMJE
  • Drug: fenugreek
    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
  • Drug: Placebo (Psyllium)
    3 capsules 3 times a day with a full glass of water each dose for 7 days
    Other Names:
    • Metamucil®,
    • Hydrocil Instant®,
    • Modane Bulk Powder®
Study Arms  ICMJE
  • Experimental: Fenugreek category 1
    receive fenugreek
    Intervention: Drug: fenugreek
  • Placebo Comparator: Placebo Category 2
    receive placebo
    Intervention: Drug: Placebo (Psyllium)
Publications * 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:CD011505. doi: 10.1002/14651858.CD011505.pub2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 14, 2012)
3
Original Estimated Enrollment  ICMJE
 (submitted: February 25, 2009)
56
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00851591
Other Study ID Numbers  ICMJE A08-3479
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Texas Tech University Health Sciences Center
Original Responsible Party Thomas W. Hale, PhD, Texas Tech University Health Sciences Center
Current Study Sponsor  ICMJE Texas Tech University Health Sciences Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Thomas W Hale, PhD Texas Tech University Health Sciences Center
PRS Account Texas Tech University Health Sciences Center
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP