NCT05924633

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: University College Dublin · Academic / Other
• Sex: Female
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Dietary Habits
• Dietary Supplements
• Maternal Health
• Breastfeeding
• Infant Health

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Supplement containing a protein hydrolysate + beta glucan (Wellmune®)	Supplement taken daily for 4 weeks.
DIETARY_SUPPLEMENT	Placebo supplement containing maltodextron	Placebo supplement taken daily for 4 weeks.

Timeline

• Start date: 2023-06-06
• Primary completion: 2024-08-31
• Completion: 2024-08-31
• First posted: 2023-06-29
• Last updated: 2024-09-19

Locations

1 site across 1 country: Ireland