Evaluation of laboratory methods for measuring the composition of breastmilk
| ISRCTN | ISRCTN54811001 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54811001 |
| IRAS number | 272907 |
| Secondary identifying numbers | CPMS 43843, IRAS 272907 |
- Submission date
- 27/01/2020
- Registration date
- 18/02/2020
- Last edited
- 17/03/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English Summary
Background and study aims
Human milk is a nutrient-rich fluid that also contains hormones, cells, antibodies, and metabolites that are transmitted to the breastfeeding infant. These milk components have the potential to influence development of the newborn. However, little is known about the overall composition of these factors within human milk. The aim of this study is the establishment of laboratory methods, which can be used in future clinical studies to investigate the biological mechanisms by which breastfeeding can influences the health and wellbeing of the infant.
Who can participate?
Healthy volunteers, who are mothers in established lactation
What does the study involve?
A breastfeeding mother will be asked to express 5-10 ml of milk. This sample will be used to evaluate a range of laboratory tests for measuring hormones, cells, antibodies, and metabolites in human milk. Normally the researchers would ask participants to provide a breast milk sample on a single occasion. However, if a mother is producing substantial amounts of breast milk, then they may ask if she is willing to provide additional samples.
What are the possible benefits and risks of participating?
The main benefit of this study is to develop better methods for measuring hormones and other factors contained in breast milk. This study is not expected to cause any adverse effects.
Where is the study run from?
The University of Oxford (UK)
When is the study starting and how long is it expected to run for?
September 2019 to January 2024
Who is funding the study?
The Family Larsson Rosenquist Foundation (Switzerland)
Who is the main contact?
Dr Fadil Hannan (scientific contact), fadil.hannan@wrh.ox.ac.uk
Contact information
Principal Investigator
Director of the Oxford Centre for the Endocrinology of Human Lactation
Nuffield Department of Women’s and Reproductive Health
Level 3, Women’s Centre
John Radcliffe Hospital
Headington
Oxford
OX3 9DU
United Kingdom
 ORCID ID |
0000-0002-2975-5170 |
|---|---|
| Phone | +44 (0)1865 222937 |
| fadil.hannan@wrh.ox.ac.uk |
Study information
| Study design | Observational; Design type: Validation of investigation /therapeutic procedures |
|---|---|
| Primary study design | Observational |
| Secondary study design | Laboratory method evaluation study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | ISRCTN54811001_PIS_V1.1_10Oct2019.pdf |
| Scientific title | The NECTAR study: Evaluation of laboratory methods for measuring the composition of breastmilk |
| Study acronym | NECTAR |
| Study hypothesis | Aim: To establish laboratory tests for measuring the composition of human breast milk Outline of research: This study involves the collection of up to 10 ml of breast milk from up to 90 women who are already expressing milk for their babies in the Oxford Newborn Care Unit, Women’s Centre, John Radcliffe Hospital, Oxford. The women are healthy volunteers and are recruited by virtue that their babies are NHS patients. The research milk samples will be used to evaluate the suitability of a range of laboratory tests for measuring hormones, cells, antibodies and metabolites in human milk. These laboratory tests will be used in future clinical studies to establish reference standards for key breast milk constituents, and to gain a greater understanding of how human milk influences the health and wellbeing of the breastfeeding infant. Justification: Human breast milk is a nutrient-rich fluid, which additionally contains many factors with the potential to influence neonatal development, metabolism and health outcomes such as diabetes, obesity and neurodevelopment. However, little is known about the concentrations of these factors in human milk, and robust laboratory tests for measuring milk hormones have not been established. |
| Ethics approval(s) | Approved 05/11/2019, West of Scotland REC 1 (West of Scotland Research Ethics Service, Ward 11, Dykebar Hospital, Grahamston Road, Paisley PA2 7DE; +44 (0)141-314-0212; WosRec1@ggc.scot.nhs.uk), ref: 19/WS/0174 |
| Condition | Composition of breast milk |
| Intervention | Study procedures: 1. Lactating mother to express 5-10 ml of breast milk into a sterile container 2. Milk sample transported to NDWRH laboratory for processing e.g. centrifugation 3. Processed milk sample analysed freshly or stored frozen for up to 3 months prior to analysis 4. Samples analysed in laboratories located in the University of Oxford or in OUHFT |
| Intervention type | Other |
| Primary outcome measure | 1. Ability to detect presence of hormones (e.g. insulin, leptin and parathyroid hormone related peptide), with samples analysed within 3 months of collection 2. Ability to detect presence of cells (e.g. mammary epithelial cells and immune cells), with samples analysed within 3 months of collection 3. Ability to detect presence of antibodies (e.g. immunoglobulin A), with samples analysed within 3 months of collection 4. Ability to detect presence of metabolites (e.g. breakdown products of bioactive substances such as serotonin), with samples analysed within 3 months of collection |
| Secondary outcome measures | - |
| Overall study start date | 01/09/2019 |
| Overall study end date | 04/01/2024 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 45 Years |
| Sex | Female |
| Target number of participants | Planned Sample Size: 90; UK Sample Size: 90 |
| Participant inclusion criteria | 1. Female aged 18 to 45 years in established lactation and >1 week post-partum 2. Able to express breast milk by hand or using a pump device 3. Willing and able to give informed consent for this study 4. Able to understand and speak English |
| Participant exclusion criteria | Limited milk supply or not lactating for any reason |
| Recruitment start date | 01/03/2021 |
| Recruitment end date | 04/01/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Headington
OX3 9DU
United Kingdom
Sponsor information
University/education
University of Oxford Clinical Trials and Research Governance
Joint Research Office
1st Floor, Boundry Brook House
Churchill Drive
Headington
Oxford
OX3 7GB
England
United Kingdom
| ctrg@admin.ox.ac.uk |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Familie Larsson-Rosenquist Stiftung, Larsson‐Rosenquist Foundation, The Family Larsson-Rosenquist Foundation, Family Larsson Rosenquist Foundation, FLRF, FLRS
- Location
- Switzerland
Results and Publications
| Intention to publish date | 31/03/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated and/or analysed during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version V1.1 | 10/10/2019 | 18/02/2020 | No | Yes |
| Protocol file | version V1.1 | 10/10/2019 | 18/02/2020 | No | No |
| HRA research summary | 28/06/2023 | No | No |
Additional files
- ISRCTN54811001_PIS_V1.1_10Oct2019.pdf
- Uploaded 18/02/2020
- ISRCTN54811001_PROTOCOL_V1.1_10Oct19.pdf
- Uploaded 18/02/2020
Editorial Notes
17/03/2023: The following changes have been made and the plain English summary updated accordingly:
1. The overall trial end date has been changed from 07/03/2023 to 04/01/2024.
2. The recruitment end date has been changed from 07/03/2022 to 04/01/2024.
3. The intention to publish date has been changed from 31/03/2024 to 31/03/2025.
4. The target number of participants has been changed from "Planned Sample Size: 30; UK Sample Size: 30" to "Planned Sample Size: 90; UK Sample Size: 90" and the study hypothesis was updated accordingly.
11/04/2022: The public contact has been deleted and the plain English summary updated accordingly.
10/03/2021: The following changes have been made:
1. Recruitment has resumed.
2. The recruitment start date has been changed from 07/03/2020 to 01/03/2021.
09/04/2020: Due to current public health guidance, recruitment for this study has been paused.
18/02/2020: The participant information sheet has been uploaded. Uploaded protocol V1.1, 10 October 2019 (not peer reviewed).
30/01/2020: Trial's existence confirmed by the National Institute for Health Research (NIHR).
