Effectiveness of Nutritional Resources for Milk Donors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-02

Study Completion Date

2026-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Maternal diet influences breast milk nutritional profile; however, a national survey undertaken by the researchers revealed that non-for-profit donor milk banks in the U.K. do not provide specific dietary information to donors. Moreover, the researchers have shown that donor milk in the U.K. provides very low levels of the omega-3 and omega-6 polyunsaturated fatty acids (PUFAs), docosahexaenoic acid (DHA) and arachidonic acid, respectively. These are essential for brain development and immune system function, and preterm infants receiving donor milk do not receive sufficient levels of these nutrients. There is therefore an urgent need to develop nutritional guidelines and resources for milk donors.

Following a systematic review the researchers developed evidence-based nutritional information resources for donors, which would also be applicable more generally to lactating mothers. Those resources were developed in consultation with donors, and healthcare professionals, including dietitians and lactation consultants.

Researchers will evaluate the effectiveness of these resources in terms of acceptance and compliance, and also changes in milk DHA content. The researchers will also assess whether providing feedback on individual's milk DHA content increases milk DHA levels. If successful these resources will be introduced into milk banks across the U.K., and promoted to the wider breastfeeding community.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Human Milk Lipid Profile Assessment and Influences of Mother's Diet

NCT03808207

Breastfeeding Human Milk Diet Habit +2 more

UNKNOWN NA

Investigating Lipid Peroxidation Products in Donor Human Milk

NCT03573531

Breast Milk Collection

COMPLETED

Lipids and Other Bioactive Compounds of Human Breast Milk

NCT03746886

Breast Milk Collection

UNKNOWN

Dietary Sugars Found In Breast Milk

NCT02940795

Lactation

COMPLETED NA

Analysis of Donor Milk

NCT05742815

Breast Milk Collection Nutrition Disorder, Infant

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is an open label intervention study which lasts eight weeks, but the researchers will operate a rolling recruitment approach, and aim to recruit on average eight participants per month over eight months, to meet the target of 60 participants. Donors will be recruited from the Countess of Chester Hospital milk bank, which is the largest milk bank in England, and typically recruits around 30 to 35 new donors per month, and the researchers are aiming for an approximate 25% conversion rate. At recruitment participants will complete a validated omega-3 polyunsaturated fatty acid (PUFA) Food Frequency Questionnaire (FFQ), provide a bloodspot sample for PUFA analysis, and 1 mL of manually expressed breast milk, which will be expressed at home and brought in by the donors. The bloodspot PUFA analysis will quantify blood docosahexaenoic acid (DHA and eicosapentaenoic acid (EPA) content, which will be used to assess baseline and endpoint participant omega-3 PUFA levels. Then follows the nutritional consultation where the nutritional information resources are provided to the participants. Participants are instructed on how to complete a three-day photo diet diary, to be submitted via a mobile phone application, such as FoodView at the start, middle and end of the study, and how to collect milk drop samples on filter paper. These milk drop samples are collected in weeks 1 and 5, as a drop on a filter paper and posted for analysis. Participants are then randomised so that half will be sent the results of this milk spot analysis, and half will not. After eight weeks there is an endpoint visit, with exit questionnaire and sample collections as at baseline.

The baseline and endpoint milk samples will be manually expressed, and where possible, expressions from more than one time-point on the day will be pooled to allow for differences in milk expression over 24 hours. Samples will be frozen at -70⁰C on the day of expression and shipped on dry ice for analysis. The blood pin prick and drop of breast milk samples will be collected as single drops onto filter paper impregnated with an antioxidant to preserve PUFAs. The paper will be air-dried, wrapped in foil, sealed in polythene bag and stored until analysis. Fatty acids from all samples will be measured by gas chromatography with flame ionisation detector. There is a good correlation between the results of liquid and dried milk spot analysis; however, the dried spot samples are only reported as percentage of total fatty acids and so will primarily be used to provide feedback to the participants. Whereas the liquid milk samples will be reported in absolute amounts as well as percent of the total fatty acids, which allows for a more complete understanding of the composition. Any surplus milk samples will be stored at -70⁰C, where they may be used in future analyses of lipid or nutrient content.

The omega-3 PUFA FFQ will be completed and analysed as per the researchers previous research. For the photo-diet diary, at the initial encounter, each participant will be instructed on how to take the images of foods and beverages over one day. All will use the participants own mobile phone with built-in camera and will use a mobile phone application, such as FoodView. Different meal components will be kept separate on the plate and participants instructed to take one picture per meal. Extra food portions or leftovers are documented by additional pictures. The photo-diaries are taken for two mid-week and one weekend days and submitted via the app for subsequent nutrient analysis using Dietplan software by the research team.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Docosahexaenoic Acid Content of the Participants Docosahexaenoic Acid Content of the Breast Milk

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Nutritional resources

Participants in this arm will be provided with the nutritional resources.

Group Type EXPERIMENTAL

Nutritional resources

Intervention Type OTHER

The participants will be provided with the nutritional resources only.

Nutritional resources and breast milk DHA content

Participants in this arm will be provided with the nutritional resources and feedback on their milk docosahexaenoic acid (DHA) levels

Group Type EXPERIMENTAL

Nutritional resources

Intervention Type OTHER

The participants will be provided with the nutritional resources only.

Milk docosahexaenoic acid levels

Intervention Type OTHER

The participants will be provided with information on the levels of docosahexaenoic acid in their breast milk.

Control

Participants in this arm will receive standard care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nutritional resources

The participants will be provided with the nutritional resources only.

Intervention Type OTHER

Milk docosahexaenoic acid levels

The participants will be provided with information on the levels of docosahexaenoic acid in their breast milk.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* New donors from the Countess of Chester Hospital milk bank
* Between six to eight weeks of giving birth

Exclusion Criteria

* Insufficient comprehension of English to understand the information sheet and consent form and complete the questionnaires
* Currently taking omega-3 PUFA dietary supplements providing greater than 200 mg DHA per day
* Body Mass Index (BMI) ≥30 kg/m2

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes