ClinicalTrials.gg
RecruitingNCT07042009VITAMINUpdated Sep 4, 2026

Effectiveness of Nutritional Resources for Milk Donors

An interventional study of Nutritional resources and Milk docosahexaenoic acid levels in Docosahexaenoic Acid Content of the Participants and Docosahexaenoic Acid Content of the Breast Milk, sponsored by University of Roehampton. Recruiting at 1 site in United Kingdom. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-04.

Sponsored by University of Roehampton · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2026; still recruiting 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

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.

Read the detailed description

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.

02

Conditions studied

  • 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
03

In context

Lead sponsor

University of Roehampton is the lead sponsor of 24 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • New donors from the Countess of Chester Hospital milk bank

Exclusion criteria

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
  • (BMI) ≥30 kg/m2
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Nutritional resources

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

    Other: Nutritional resources

  • Experimental
    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

    Other: Nutritional resources · Other: Milk docosahexaenoic acid levels

  • No intervention
    Control

    Participants in this arm will receive standard care.

Interventions

  • OtherNutritional resources

    The participants will be provided with the nutritional resources only.

  • OtherMilk docosahexaenoic acid levels

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

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
  • Chester Milk Bank
    Chester, United Kingdom
    Recruiting
08

References and documents

Publications

  • 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. PubMed 32048312 ↗
  • 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. PubMed 38053371 ↗
  • 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. PubMed 27756480 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Apr 2026 (actual). Primary completion is estimated for Feb 2027, 10 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 1, 2025
First posted
Jun 27, 2025
StartActual
Apr 2, 2026
Primary completionEst.
Feb 11, 2027
CompletionEst.
Feb 11, 2027
Last update
Sep 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07042009
Lead sponsor
University of Roehampton
Collaborators
Countess of Chester NHS Foundation Trust
Responsible party
Dr Simon Dyall (Associate Professor, University of Roehampton) — Principal investigator
First posted
Jun 27, 2025
Start date
Apr 2, 2026
Primary completion
Feb 11, 2027 (estimated)
Completion
Feb 11, 2027 (estimated)
Last update
Sep 4, 2026

Study contacts

Coralie Falize
Contact
falizec@roehampton.ac.uk
+44 (0)2083923538
Jacqueline Chan, PhD
Contact
jacqueline.chan@roehampton.ac.uk
Simon Dyall, PhD
study chair · University of Roehampton
Yvonne Jeanes, PhD
study director · British Dietetic Association

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion