Effect of Fenugreek on Milk Production (fenugreek)

This study has been terminated.
(Low enrollment; investigator chose not to continue study)
Sponsor:
Information provided by (Responsible Party):
Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier:
NCT00851591
First received: February 24, 2009
Last updated: June 30, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Lactation
Drug: fenugreek
Drug: Placebo (Psyllium)
Phase 2
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Texas Tech University Health Sciences Center:

Primary Outcome Measures:
  • The Main Outcome Variable of This Study is the Quantity of Milk Produced. [ Time Frame: "Day 0" , "Day 8" ] [ Designated as safety issue: No ]
    The single value was calculated average from day 0 and day 8.


Secondary Outcome Measures:
  • Secondary Outcome Variables Are to Include Milk-fat Content and Protein Content. [ Time Frame: day 0; day 8 ] [ Designated as safety issue: No ]

Enrollment: 3
Study Start Date: September 2008
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fenugreek category 1
receive fenugreek
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
Placebo Comparator: Placebo Category 2
receive placebo
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®

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00851591

Locations
United States, Texas
Texas Tech University Health Sciences Center School of Medicine
Amarillo, Texas, United States, 79106
Sponsors and Collaborators
Texas Tech University Health Sciences Center
Investigators
Study Director: Thomas W Hale, PhD Texas Tech University Health Sciences Center
  More Information

No publications provided

Responsible Party: Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier: NCT00851591     History of Changes
Other Study ID Numbers: A08-3479
Study First Received: February 24, 2009
Results First Received: January 24, 2014
Last Updated: June 30, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Texas Tech University Health Sciences Center:
fenugreek
galactogogue
breastmilk
Trigonella foenum-graecum
Bird's Foot
Greek Clover
Greek Hay
Hu Lu Ba
Trigonella

Additional relevant MeSH terms:
Fenugreek seed meal
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 29, 2014