A nutritional supplement for better breastfeeding?

A nutritional supplement (Fenugreek) for improved breastfeeding outcomes in women at risk of low breastmilk supply

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15073373

Enrollment

Registered

2020-10-28

Start date

2020-09-01

Completion date

Unknown

Last updated

2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low breast milk supply in women with gestational diabetes mellitus Nutritional, Metabolic, Endocrine Diabetes mellitus arising in pregnancy

Interventions

Eligible participants will be asked to take a 28-day supply of the food supplement Fenugreek. 7.5g Fenugreek seed extract (FSE) powder provided as 938 mg 8:1 concentrated FSE. At baseline, prior to co

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Recent pregnancy affected by gestational diabetes mellitus 2. Intention to breastfeed for at least the trial period of 4 weeks

Exclusion criteria

Exclusion criteria: 1. Age <18 2. Pre-existing diabetes 3. Low birth weight <2.5 kg 4. Congenital anomalies 5. Low Apgar score 6. NICU admission 7. Breastfeeding not recommended e.g. maternal HIV infection

Design outcomes

Primary

Measure	Time frame
1. Breast milk composition measured using metabolomics and transcriptome analysis (NMR and MS) after the supplement course (28 days) 2. Breastfeeding self-efficacy measured using Breastfeeding Self Efficacy Scale Short Form at 28 days 3. Blood biomarkers: glucose and blood lipids measured using the Randox Daytona autoanalyzer, insulin and adiponectin measured using ELISA techniques at 6 weeks postpartum	—

Measure

Time frame

1. Breast milk composition measured using metabolomics and transcriptome analysis (NMR and MS) after the supplement course (28 days) 2. Breastfeeding self-efficacy measured using Breastfeeding Self Efficacy Scale Short Form at 28 days 3. Blood biomarkers: glucose and blood lipids measured using the Randox Daytona autoanalyzer, insulin and adiponectin measured using ELISA techniques at 6 weeks postpartum

—

Secondary

Measure	Time frame
1. Information on breastfeeding history collected by questionnaire at the time of recruitment 2. Anthropometric measured at Day 1 postnatal: 2.1. Mother: weight (kg), height (cm), calculated BMI (weight/height in metres squared) 2.2. Infant: birth weight (g), length (cm), head circumference (cm) and plotted on WHO centiles (%) 3. Symptoms related to fenugreek use measured using diary at weekly intervals for 28 days 4. Compliance measured using returned pill boxes at the end of the supplement course (28 days) 5. Maternal experience interview using qualitative analysis methods at the end of the trial (28 days)	—

Measure

Time frame

1. Information on breastfeeding history collected by questionnaire at the time of recruitment 2. Anthropometric measured at Day 1 postnatal: 2.1. Mother: weight (kg), height (cm), calculated BMI (weight/height in metres squared) 2.2. Infant: birth weight (g), length (cm), head circumference (cm) and plotted on WHO centiles (%) 3. Symptoms related to fenugreek use measured using diary at weekly intervals for 28 days 4. Compliance measured using returned pill boxes at the end of the supplement course (28 days) 5. Maternal experience interview using qualitative analysis methods at the end of the trial (28 days)

—

Countries

Ireland

Contacts

Public ContactNiamh Keating

niamh.keating@ucdconnect.ie+353 (0)16373100

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026