An interventional study of Supplement containing a protein hydrolysate + beta glucan (Wellmune®) and Placebo supplement containing maltodextron in Dietary Habits, Dietary Supplements and Maternal Health, sponsored by University College Dublin. Completed at 1 site in Ireland. Open to female participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by University College Dublin · Not applicable, Interventional, and Other
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.
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.
244 studies on the registry are indexed under Feeding Behavior; 101 are open to participants now.
This study's enrollment of 57 is below the median of 80 across 182 interventional studies indexed under Feeding Behavior.
Browse Feeding Behavior studies →University College Dublin is the lead sponsor of 113 studies on the registry; 32 are open to participants now.
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Exclusion Criteria:
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®)
The control group will consume a placebo supplement containing maltodextrin daily for 4 weeks.
Dietary Supplement: Placebo supplement containing maltodextron
Supplement taken daily for 4 weeks.
Placebo supplement taken daily for 4 weeks.
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.
Time frame: 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.
Time frame: 4 weeks
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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 4 weeks
Plan to share: No — 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.
Ran from Jun 2023 to primary completion in Aug 2024, 14 months.
Of 146 non-industry interventional studies with no phase under Feeding Behavior, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 48. This study's 14 months is below that.
Counting every sponsor, half of 147 studies reached it within 27 months; a quarter within 7 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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