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

NCT05924633 | Completed

• 1 other identifier: LS-23-07-OSullivan
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dietary Habits; Dietary Supplements; Maternal Health; Breastfeeding; Infant Health

Keywords

Breastfeeding; Dietary Supplements

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• Digestive health - SAGIS score

  4 weeks

• Markers of metabolic health in blood - glucose

  4 weeks

• Markers of metabolic health in blood - insulin

  4 weeks

• Markers of metabolic health in blood - triacylglycerol

  4 weeks

• Markers of metabolic health in blood - cholesterol

  4 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

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®)

Control group

PLACEBO COMPARATOR

The control group will consume a placebo supplement containing maltodextrin daily for 4 weeks.

Dietary Supplement: Placebo supplement containing maltodextron

Interventions

Supplement containing a protein hydrolysate + beta glucan (Wellmune®) DIETARY_SUPPLEMENT

Supplement taken daily for 4 weeks.

Intervention group

Placebo supplement containing maltodextron DIETARY_SUPPLEMENT

Placebo supplement taken daily for 4 weeks.

Control group

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University College Dublin: lead

Study Sites (1)

University College Dublin

Dublin, Ireland

Location

MeSH Terms

Conditions

Feeding Behavior; Breast Feeding

Interventions

beta-Glucans

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Intervention Hierarchy (Ancestors)

Glucans; Polysaccharides; Carbohydrates

Study Officials

• Aifric O'Sullivan, PhD

  University College Dublin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blinded parallel study
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor and Principal Investigator

Model Details: Parallel randomised control trail

Study Record Dates

• First Submitted: June 8, 2023
• First Posted: June 29, 2023
• Study Start: June 6, 2023
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)