A Study of a Dietary Supplement in Breastfeeding Mothers (WellFed)

This is a randomized placebo-controlled study that aims to investigate the effect of a new maternal dietary supplement (protein hydrolysate/yeast beta-glucan combination) on mother and infant health.

Study Overview

• Status: Recruiting
• Conditions: Dietary Habits; Maternal Health; Breastfeeding; Dietary Supplements; Infant Health
• Intervention / Treatment: Dietary supplement: Supplement containing a protein hydrolysate + beta glucan (Wellmune®); Dietary supplement: Placebo supplement containing maltodextron

Detailed Description

N=140 healthy pregnant multiparous females aged between 18-49 years will be recruited to the study during pregnancy or up to 4-weeks postpartum, n=70 consuming the supplement and n=70 consuming a placebo. Following successful recruitment and screening, researchers will complete 2 study visits at the participant's home. Visit 1 marks the start of the intervention period and Visit 2 marks the end of the intervention period.

Once the baseline data is completed (visit 1), the capsules will be provided to the mother. One capsule will be taken daily for 4 weeks. Capsules will be provided in convenient weekly tablet boxes. The return of used tablet boxes and counting missing capsules will monitor compliance. In addition, regular weekly contact will be maintained by phone and text message with participants to encourage adherence. In addition to the 2 study visits, all participants will receive an individual consultation with a lactation consultant to ensure breastfeeding techniques are appropriate and not a confounding factor in the breastmilk supply.

Data collection will include:

Anthropometric measurements include weight, height/length, and circumferences. Questionnaires will be used to collect birth data, demographic, lifestyle, breastfeeding and infant behavior, socio-economic status, health history, and gut health information.

Dietary intakes will be assessed using an online 24-hour recall tool. Blood samples will be collected from mothers by a trained phlebotomist. A 5mL aliquot of breast milk will be collected from a full breast milk expression in the 24 hours prior to the research nurse visit using an electric breast pump. Mothers will record the volume of milk expressed and the remainder will be stored by the mother for the infant. for will use an electric breast pump for a full breast expression. The aliquot will be refrigerated until the research nurse visit.

Mothers will collect a fecal sample from themselves and a fecal and urine sample from their baby in the 24 hours prior to the visit and will be stored in the freezer until the research nurse visit.

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aifric O'Sullivan, PhD; Phone Number: +353 1 716 2824; Email: aifric.osullivan@ucd.ie

Study Locations

• Ireland
  • Dublin, Ireland
    • Recruiting
    • University College Dublin
    • Contact: Aifric O'Sullivan, PhD; Phone Number: +353 1 7162824; Email: aifric.osullivan@ucd.ie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Postpartum women aged 18-49 years
• Multiparous with one previously breastfed child (defined as breastfed for greater than or equal to 3 months, does not need to be exclusively breastfed)
• Delivered term
• Woman free of breast or nipple infections
• Woman willing to avoid other galactagogues/breastmilk supply stimulants while on study
• Woman not taking medications that will affect lactation
• Woman is the established carer for the infant
• Infant has no baseline abnormality.

Exclusion Criteria:

• Less than 18 years old or older than 49 years (at time of recruitment)
• Smokers
• Individuals that are not free-living e.g. institutes where meals are prepared in bulk such as nursing homes, prisons etc.
• An inability to read, write or understand English
• Following a strict prescribed diet for any reason; insulin dependent diabetes, coeliac disease, Crohn's disease etc. as this may result in an altered gastrointestinal function.
• Mother or child has a milk protein allergy
• Covid-19 at very high-risk group (defined by HSE)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; The intervention group will receive a supplement to take daily for 4 weeks. The supplement contains a combination of a protein hydrolysate and beta-glucan (Wellmune®).	Dietary supplement: Supplement containing a protein hydrolysate + beta glucan (Wellmune®); Supplement taken daily for 4 weeks.
Placebo Comparator: Control group; The control group will consume a placebo supplement containing maltodextrin daily for 4 weeks.	Dietary supplement: Placebo supplement containing maltodextron; Placebo supplement taken daily for 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Expression of inflammatory cytokines in blood - TNF-alpha	The effect of the dietary supplement on TNF-alpha expression in blood collected from mothers will be measured using a gene expression assay of more than 200 genes (e.g., IL-1, IL-6, IL-8, TNF-a) at baseline and endpoint (week 4). TNF-alpha expression will be measured as Ct values and reported as relative quantities.	4 weeks
Expression of inflammatory cytokines in blood - IL-8	The effect of the dietary supplement on IL-8 expression in blood collected from mothers will be measured using a gene expression assay of more than 200 genes (e.g., IL-1, IL-6, IL-8, TNF-a) at baseline and endpoint (week 4). IL-8 expression will be measured as Ct values and reported as relative quantities.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Digestive health - SAGIS score	The effect of the dietary supplement on the digestive health of the mother will be measured using the Structured Assessment of Gastrointestinal Symptoms Scale (SAGIS) questionnaire at baseline and endpoint (4 weeks). SAGIS assesses gastrointestinal symptoms using a Likert scale 0-4 which is summed to give the SAGIS score.	4 weeks
Markers of metabolic health in blood - glucose	The effect of the dietary supplement on glucose concentrations (mmol/L) in blood collected from mothers will be measured using the HORIBA Pentra C400 at baseline and endpoint (week 4).	4 weeks
Markers of metabolic health in blood - insulin	The effect of the dietary supplement on insulin concentrations (mU/L) in blood collected from mothers will be measured using the HORIBA Pentra C400 at baseline and endpoint (week 4).	4 weeks
Markers of metabolic health in blood - triacylglycerol	The effect of the dietary supplement on triacylglycerol concentrations (mmol/L) in blood collected from mothers will be measured using the HORIBA Pentra C400 at baseline and endpoint (week 4).	4 weeks
Markers of metabolic health in blood - cholesterol	The effect of the dietary supplement on cholesterol concentrations (mmol/L) in blood collected from mothers will be measured using the HORIBA Pentra C400 at baseline and endpoint (week 4).	4 weeks
Secretory IgA in breastmilk	The effect of the dietary supplement on secretory IgA concentrations (ng/mL) in breastmilk collected from mothers will be measured using an ELISA at baseline and endpoint (week 4).	4 weeks
Breastmilk production volumn	The effect of the dietary supplement on breastmilk production will be measured by a full breast expression (mL) at baseline and endpoint (week 4).	4 weeks
Expression of inflammatory cytokines in blood	The effect of the dietary supplement on inflammatory cytokines in blood collected from mothers will be measured using a gene expression assay of more than 200 genes (e.g., IL-1, IL-6, IL-8, TNF-a) at baseline and endpoint (week 4).	4 weeks
Microbiota profile in feces	The effect of the dietary supplement on the gut microbiota profile of fecal samples collected from mothers and infants. Gut microbiota will be profiled using 16S rRNA sequencing and QIIME software at baseline and endpoint (week 4).	4 weeks
Microbiota profile in breastmilk	The effect of the dietary supplement on the gut microbiota profile of breastmilk samples collected from mothers. Microbiota will be profiled using 16S rRNA sequencing and QIIME software at baseline and endpoint (week 4).	4 weeks

Collaborators and Investigators

• Sponsor: University College Dublin
• Investigators: Principal Investigator: Aifric O'Sullivan, PhD, University College Dublin

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: June 8, 2023
• First Submitted That Met QC Criteria: June 26, 2023
• First Posted (Actual): June 29, 2023

Study Record Updates

• Last Update Posted (Actual): June 29, 2023
• Last Update Submitted That Met QC Criteria: June 26, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Breastfeeding; Dietary Supplements
• Other Study ID Numbers: LS-23-07-OSullivan

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: At the start of the study each participant will have a study code assigned to them. All of the data from the trials will be stored using these unique study codes. A file will be set up which will be stored in a location separate to the study data. This file will contain a list which will link each participants contact details to the corresponding ID code. All stored information will be encrypted and protected by a password that only the researcher and PI will know.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No