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Effectiveness of Nutritional Resources for Milk Donors

NCT07042009 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-05-20

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

OTHER

Nutritional resources

The participants will be provided with the nutritional resources only.

OTHER

Milk docosahexaenoic acid levels

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

Sponsors & Collaborators

  • Countess of Chester NHS Foundation Trust

    collaborator OTHER

  • University of Roehampton

    lead OTHER

Principal Investigators

  • Simon Dyall, PhD · University of Roehampton

  • Yvonne Jeanes, PhD · British Dietetic Association

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-04-02
Primary Completion
2026-10-31
Completion
2026-10-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07042009 on ClinicalTrials.gov