Condition category
Nutritional, Metabolic, Endocrine
Date applied
27/01/2020
Date assigned
18/02/2020
Last edited
09/04/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Suspended

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 March 2023

Who is funding the study?
The Family Larsson Rosenquist Foundation (Switzerland)

Who is the main contact?
1. Helen Price (public contact), helen.price@wrh.ox.ac.uk
2. Dr Fadil Hannan (scientific contact), fadil.hannan@wrh.ox.ac.uk

Trial website

https://www.ocehl.com/nectar

Contact information

Type

Public

Primary contact

Ms Helen Price

ORCID ID

Contact details

Research Midwife
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
+44 (0)1865 221074
helen.price@wrh.ox.ac.uk

Type

Scientific

Additional contact

Dr Fadil Hannan

ORCID ID

https://orcid.org/0000-0002-2975-5170

Contact details

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
+44 (0)1865 222937
fadil.hannan@wrh.ox.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

CPMS 43843, IRAS 272907

Study information

Scientific title

The NECTAR study: Evaluation of laboratory methods for measuring the composition of breastmilk

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 30 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

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

Study design

Observational; Design type: Validation of investigation /therapeutic procedures

Primary study design

Observational

Secondary study design

Laboratory method evaluation study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

See additional files

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

Phase

Drug names

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 trial start date

01/09/2019

Overall trial end date

07/03/2023

Reason abandoned (if study stopped)

Eligibility

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 type

Healthy volunteer

Age group

Adult

Gender

Female

Target number of participants

Planned Sample Size: 30; UK Sample Size: 30

Participant exclusion criteria

Limited milk supply or not lactating for any reason

Recruitment start date

07/03/2020

Recruitment end date

07/03/2022

Locations

Countries of recruitment

United Kingdom

Trial participating centre

John Radcliffe Hospital
Headley Way
Headington
OX3 9DU
United Kingdom

Sponsor information

Organisation

University of Oxford

Sponsor details

University of Oxford Clinical Trials and Research Governance
Joint Research Office
1st Floor
Boundry Brook House
Churchill Drive
Headington
Oxford
OX3 7GB
United Kingdom
-
ctrg@admin.ox.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Family Larsson‐Rosenquist Foundation

Alternative name(s)

Familie Larsson-Rosenquist Stiftung, Larsson‐Rosenquist Foundation

Funding Body Type

private sector organisation

Funding Body Subtype

Trusts, charities, foundations (both publically funded and privately funded)

Location

Switzerland

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
The datasets generated and/or analysed during this study will be included in the subsequent results publication.

Intention to publish date

31/03/2024

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

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).