Effect of Fenugreek on Milk Production (fenugreek)

• ClinicalTrials.gov Identifier: NCT00851591
• Recruitment Status: Terminated
• First Posted: February 26, 2009
• Results First Posted: July 28, 2014
• Last Update Posted: June 26, 2018
• Sponsor: Texas Tech University Health Sciences Center
• Information provided by (Responsible Party): Texas Tech University Health Sciences Center

Tracking Information

• First Submitted Date: February 24, 2009
• First Posted Date: February 26, 2009
• Results First Submitted Date: January 24, 2014
• Results First Posted Date: July 28, 2014
• Last Update Posted Date: June 26, 2018
• Study Start Date: September 2008
• Actual Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (submitted: February 25, 2009): The main outcome variable of this study will be the quantity of milk produced. [ Time Frame: day 0; day 8 ]

Current Secondary Outcome Measures (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 (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: Effect of Fenugreek on Milk Production
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Lactation

Intervention

• 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

• 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(5):CD011505. doi: 10.1002/14651858.CD011505.pub2.

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: December 14, 2012): 3
• Original Estimated Enrollment (submitted: February 25, 2009): 56
• Actual Study Completion Date: August 2012
• Actual Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 45 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00851591
• Other Study ID Numbers: A08-3479
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: 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: Texas Tech University Health Sciences Center
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Thomas W Hale, PhD; Texas Tech University Health Sciences Center

• PRS Account: Texas Tech University Health Sciences Center
• Verification Date: May 2018