Dietary HabitsNCT05924633
A Study of a Dietary Supplement in Breastfeeding Mothers (WellFed)
A study testing Supplement containing a protein hydrolysate + beta glucan (Wellmune®) in people with Dietary Habits and Dietary Supplements, run by University College Dublin at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dietary Habits, Dietary Supplements, Maternal Health
- What is being tested?
- Supplement containing a protein hydrolysate + beta glucan (Wellmune®)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteIreland
- Study dates
- 6 Jun 2023to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Supplement containing a protein hydrolysate + beta glucan (Wellmune®), Placebo supplement containing maltodextron
- Keywords
- Breastfeeding, Dietary Supplements
- Medical subject headings
- Feeding Behavior, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supplement containing a protein hydrolysate + beta glucan (Wellmune®)Dietary supplement
Supplement taken daily for 4 weeks.
Placebo supplement containing maltodextronDietary supplement
Placebo supplement taken daily for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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®). Receives: 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. Receives: Dietary Supplement: Placebo supplement containing maltodextron |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 4 weeks
Secondary outcomes (10)
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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start6 Jun 2023
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dietary HabitsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel randomised control trail
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Dublin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aifric O'Sullivan, University College Dublin
- Investigators
- Aifric O'Sullivan, PhD, Principal investigator, University College Dublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05924633
- Sponsor's protocol ID
- LS-23-07-OSullivan
- Status last verified
- Sep 2024
- First submitted
- 8 Jun 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Ali M, O'Dwyer F, Murphy B, Bottu HM, Rooney M, Sweeney T, O' Reilly SL, O'Sullivan AM. Vitamins A, D, E, and K Intakes, Status, and Breastmilk Concentrations in Breastfeeding Women in Ireland. J Nutr. 2026 Jul;156(7):101611. doi: 10.1016/j.tjnut.2026.101611. Epub 2026 May 22.
PubMed 42176989
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of a Dietary Supplement in Breastfeeding Mothers (WellFed)
- ClinicalTrials.gov ID
- NCT05924633
- Acronym / sponsor ID
- LS-23-07-OSullivan
- Keywords
- Breastfeeding, Dietary Supplements
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University College DublinUniversity, hospital or other
- Study start
- 6 Jun 2023 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 29 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Parallel randomised control trail
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Dietary Supplement: Supplement containing a protein hydrolysate + beta glucan (Wellmune®)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®). |
| Control group | Placebo comparator | Dietary Supplement: Placebo supplement containing maltodextronThe control group will consume a placebo supplement containing maltodextrin daily for 4 weeks. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supplement containing a protein hydrolysate + beta glucan (Wellmune®)Supplement taken daily for 4 weeks. | Dietary supplement | Intervention group |
| Placebo supplement containing maltodextronPlacebo supplement taken daily for 4 weeks. | Dietary supplement | Control group |
Primary outcome
Expression of inflammatory cytokines in blood - TNF-alpha
Time frame: 4 weeks
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.
Expression of inflammatory cytokines in blood - IL-8
Time frame: 4 weeks
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.
10 secondary outcomes
Digestive health - SAGIS score
Time frame: 4 weeks
Markers of metabolic health in blood - glucose
Time frame: 4 weeks
Markers of metabolic health in blood - insulin
Time frame: 4 weeks
Markers of metabolic health in blood - triacylglycerol
Time frame: 4 weeks
Markers of metabolic health in blood - cholesterol
Time frame: 4 weeks
Secretory IgA in breastmilk
Time frame: 4 weeks
Breastmilk production volumn
Time frame: 4 weeks
Expression of inflammatory cytokines in blood
Time frame: 4 weeks
Microbiota profile in feces
Time frame: 4 weeks
Microbiota profile in breastmilk
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 42176989Ali M, O'Dwyer F, Murphy B, Bottu HM, Rooney M, Sweeney T, O' Reilly SL, O'Sullivan AM. Vitamins A, D, E, and K Intakes, Status, and Breastmilk Concentrations in Breastfeeding Women in Ireland. J Nutr. 2026 Jul;156(7):101611. doi: 10.1016/j.tjnut.2026.101611. Epub 2026 May 22.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aifric O'Sullivan, PhD principal investigator
University College Dublin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supplement containing a protein hydrolysate + beta glucan (Wellmune®) in people with Dietary Habits and Dietary Supplements, run by University College Dublin at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expression of inflammatory cytokines in blood - TNF-alpha (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05924633, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.