Effectiveness of Nutritional Resources for Milk Donors

NCT07042009 | Not Yet Recruiting

• 1 other identifier: SD002
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

omega-3 fatty acids; donor human milk; human milk bank; preterm infants; DHA; docosahexaenoic acid

Outcome Measures

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.

  8 weeks

Secondary Outcomes (2)

• Concentration of docosahexaenoic acid in the participants breast milk

  8 weeks

• Concentration of omega-3 fatty acids in the participants blood

  8 weeks

Study Arms (3)

Nutritional resources

EXPERIMENTAL

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

Other: Nutritional resources

Nutritional resources and breast milk DHA content

EXPERIMENTAL

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

Other: Nutritional resources; Other: Milk docosahexaenoic acid levels

Control

NO INTERVENTION

Participants in this arm will receive standard care.

Interventions

Nutritional resources OTHER

The participants will be provided with the nutritional resources only.

Nutritional resources; Nutritional resources and breast milk DHA content

Milk docosahexaenoic acid levels OTHER

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

Nutritional resources and breast milk DHA content

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Roehampton: lead
• Countess of Chester NHS Foundation Trust: collaborator

Related Publications (3)

• Nessel I, De Rooy L, Khashu M, Murphy JL, Dyall SC. Long-Chain Polyunsaturated Fatty Acids and Lipid Peroxidation Products in Donor Human Milk in the United Kingdom: Results From the LIMIT 2-Centre Cross-Sectional Study. JPEN J Parenter Enteral Nutr. 2020 Nov;44(8):1501-1509. doi: 10.1002/jpen.1773. Epub 2020 Feb 11.

  PMID: 32048312 BACKGROUND

• Falize C, Savage M, Jeanes YM, Dyall SC. Evaluating the relationship between the nutrient intake of lactating women and their breast milk nutritional profile: a systematic review and narrative synthesis. Br J Nutr. 2024 Apr 14;131(7):1196-1224. doi: 10.1017/S0007114523002775. Epub 2023 Dec 6.

  PMID: 38053371 BACKGROUND

• De Rooy L, Hamdallah H, Dyall SC. Extremely preterm infants receiving standard care receive very low levels of arachidonic and docosahexaenoic acids. Clin Nutr. 2017 Dec;36(6):1593-1600. doi: 10.1016/j.clnu.2016.09.033. Epub 2016 Oct 8.

  PMID: 27756480 BACKGROUND

Study Officials

• Simon Dyall, PhD

  University of Roehampton

  STUDY CHAIR

• Yvonne Jeanes, PhD

  British Dietetic Association

  STUDY DIRECTOR

Central Study Contacts

Coralie Falize

CONTACT

+44 (0)2083923538; falizec@roehampton.ac.uk

Jacqueline Chan, PhD

CONTACT

jacqueline.chan@roehampton.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: June 27, 2025
• Study Start: February 2, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share