Effectiveness of Nutritional Resources for Milk Donors

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Roehampton

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Nutritional resources

    Other intervention

    The participants will be provided with the nutritional resources only.

  • Milk docosahexaenoic acid levels

    Other intervention

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

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Nutritional resourcesExperimental treatment 1 intervention
Group B: Nutritional resources and breast milk DHA contentExperimental treatment 2 interventions
Group C: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Content of omega-3 fatty acids in the participants diet

The omega-3 fatty acid content of the participants diet will be assessed from three-day photo-diet diaries taken at the start and end of the study. The participants will use their own mobile phone with a phone application, such as FoodView to record their meals. The omega-3 fatty acid values for alpha-linolenic acid, eicosapentaenoic acid and docosahexaenoic will then be calculated in mg/day from these images using nutrient analysis software, such as Dietplan, and intake levels will be compared between the baseline and endpoint values.

Time frame
8 weeks

Secondary outcomes

1

Concentration of docosahexaenoic acid in the participants breast milk

The concentration of docosahexaenoic acid in the participants breast milk will be measured by gas chromatography from samples taken at the start and end of the study.

Time frame
8 weeks
2

Concentration of omega-3 fatty acids in the participants blood

The omega-3 fatty acid concentration of the participants non-fasted blood will be assessed by measuring the docosahexaenoic and eicosapentaenoic acid levels from pin-prick whole-blood samples taken at the start and end of the study. The samples will be analysed by gas chromatography.

Time frame
8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Roehampton

Lead sponsor

Countess of Chester NHS Foundation Trust

Collaborator