LactationfenugreekNCT00851591
Effect of Fenugreek on Milk Production
A study testing fenugreek in people with Lactation, run by Texas Tech University Health Sciences Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Lactation
- What is being tested?
- fenugreek
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Aug 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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:
Show all 20Show fewer
- Diuretics
- Pseudoephedrine
- Anticholinergics
- Warfarin or any anticoagulant
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Tech University Health Sciences Center School of Medicine
Amarillo, Texas, 79106
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Lactation
- Being tested
- fenugreek, Placebo (Psyllium)
- Keywords
- fenugreek, galactogogue, breastmilk, Trigonella foenum-graecum, Bird's Foot, Greek Clover, Greek Hay, Hu Lu Ba, Trigonella
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fenugreekDrug
Also called Trigonella foenum-graecum, Alhova, Bird's Foot, Greek Clover
3 capsules 3 times per day with a full glass of water each dose for 7 days
Placebo (Psyllium)Drug
Also called Metamucil®,, Hydrocil Instant®,, Modane Bulk Powder®
3 capsules 3 times a day with a full glass of water each dose for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Fenugreek category 1 | Experimental | receive fenugreek Receives: Drug: fenugreek |
| Placebo Category 2 | Placebo comparator | receive placebo Receives: Drug: Placebo (Psyllium) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Main Outcome Variable of This Study is the Quantity of Milk Produced.
The single value of this variable was calculated average from day 0 and day 8.
Measured: "Day 0" , "Day 8"
Secondary outcomes (1)
Secondary Outcome Variables Are to Include Milk-fat Content and Protein Content.
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.
Measured: day 0; day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2009 (estimated)
- Study startSep 2008
- Primary completionAug 2012
- Study completionAug 2012
Why it stopped: Low enrollment; investigator chose not to continue study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LactationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas W Hale, PhD, Study director, Texas Tech University Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00851591
- Sponsor's protocol ID
- A08-3479
- Acronym
- fenugreek
- Status last verified
- May 2018
- First submitted
- 24 Feb 2009
- Last updated
- 26 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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.
PubMed 32421208
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Fenugreek on Milk Production
- ClinicalTrials.gov ID
- NCT00851591
- Acronym / sponsor ID
- fenugreek / A08-3479
- Conditions
- Lactation
- Keywords
- fenugreek, galactogogue, breastmilk, Trigonella foenum-graecum, Bird's Foot, Greek Clover, Greek Hay, Hu Lu Ba
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment; investigator chose not to continue study
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Texas Tech University Health Sciences CenterUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 26 Feb 2009 (estimated)
- Results
- Posted 28 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fenugreek category 1 | Experimental | Drug: fenugreekreceive fenugreek |
| Placebo Category 2 | Placebo comparator | Drug: Placebo (Psyllium)receive placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fenugreekAlso: Trigonella foenum-graecum, Alhova, Bird's Foot, Greek Clover3 capsules 3 times per day with a full glass of water each dose for 7 days | Drug | Fenugreek category 1 |
| Placebo (Psyllium)Also: Metamucil®,, Hydrocil Instant®,, Modane Bulk Powder®3 capsules 3 times a day with a full glass of water each dose for 7 days | Drug | Placebo Category 2 |
Primary outcome
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.
1 secondary outcome
Secondary Outcome Variables Are to Include Milk-fat Content and Protein Content.
Time frame: day 0; day 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32421208Foong 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas W Hale, PhD study director
Texas Tech University Health Sciences Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fenugreek in people with Lactation, run by Texas Tech University Health Sciences Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Main Outcome Variable of This Study is the Quantity of Milk Produced. (time frame: "Day 0" , "Day 8"). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00851591, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2018.