Breastfeeding Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 140 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 49 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Ireland | University College Dublin | Dublin |
Lead Sponsor | Collaborator |
---|---|
University College Dublin |
Ireland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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