Ergothioneine and pre-eclampsia study
| ISRCTN | ISRCTN95250355 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95250355 |
| IRAS number | 356273 |
| Secondary identifying numbers | UoL001943 |
- Submission date
- 15/09/2025
- Registration date
- 20/10/2025
- Last edited
- 14/10/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
Pre-eclampsia is a condition that can occur during pregnancy, causing high blood pressure and other complications that may affect both the mother and baby. Diet is thought to play an important role in the development and prevention of pre-eclampsia. This study aims to explore whether there are differences in diet quality and in the intake of a naturally occurring nutrient called ergothioneine, found in foods such as mushrooms, between pregnant women who have pre-eclampsia and those who do not. The study will also assess how easy and acceptable two online dietary assessment tools are for pregnant women to use.
Who can participate?
Pregnant women aged 18 years or older diagnosed with and without pre-eclampsia who live in the Liverpool region.
What does the study involve?
Participants will complete a short online survey that first collects essential demographic and clinical information (ethnicity, age, educational levels, occupation, dietary preferences, pre-eclampsia diagnosis and week of pregnancy) and then asks about the frequency of typical food consumption in the last month and specifics about dietary intake in the previous 24 hours. Participants will also be asked to provide feedback on how easy these tools are to use. All data will be collected online and will take around 20-25 minutes to complete in total.
What are the possible benefits and risks of participating?
There are no direct health benefits for participants, but the findings may help researchers better understand how diet relates to pre-eclampsia and improve future dietary advice for pregnant women.
To thank participants for their time, they will receive a £10 voucher once they have completed the study. In addition, a leaflet with information about healthy eating during pregnancy will be sent via email.
There are no known risks to taking part. All data will be collected anonymously and kept strictly confidential. Participants can withdraw from the study at any time without giving a reason.
Where is the study run from?
The study is run by the University of Liverpool, in collaboration with Liverpool Women’s Hospital, UK.
When is the study starting and how long is it expected to run for?
January 2025 to March 2027.
Who is funding the study?
The University of Liverpool, UK.
Who is the main contact?
Prof J Bernadette Moore, Biochemistry, Cell and Systems Biology, Institute of Systems, Molecular and Integrative Biology, University of Liverpool, J.Bernadette.Moore@liverpool.ac.uk
Contact information
Principal investigator
Biochemistry, Cell and Systems Biology
Institute of Systems, Molecular and Integrative Biology
University of Liverpool
Crown Street
Liverpool
L69 7ZB
United Kingdom
 ORCID ID |
0000-0003-4750-1550 |
|---|---|
| Phone | +44 (0)151 795 1683 |
| J.Bernadette.Moore@liverpool.ac.uk |
Public, Scientific
Biochemistry, Cell and Systems Biology
Institute of Systems, Molecular and Integrative Biology
University of Liverpool
Crown Street
Liverpool
L69 7ZB
United Kingdom
| ORCID ID |
0000-0003-3053-3089 |
|---|---|
| Phone | +44 (0)151 795 1683 |
| Aslihan.Ozdemir@liverpool.ac.uk |
Study information
| Study design | Observational case-control study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case-control study |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Investigating dietary ergothioneine and dietary quality in pregnant women with and without pre-eclampsia |
| Study acronym | Erg-PE |
| Study objectives | 1. To survey ergothioneine intake in pregnant women. 2. To compare ergothioneine intakes between those with and without pre-eclampsia. 3. To compare diet quality scores between those with and without pre-eclampsia. 4. To compare dietary nutrient intakes between those with and without pre-eclampsia. |
| Ethics approval(s) |
1. Approved 28/05/2025, HRA and Health and Care Research Wales (HCRW) (Health Research Authority, 2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)207 104 8000; bloomsbury.rec@hra.nhs.uk), ref: 25/PR/0434 2. Approved 18/08/2025, HRA and Health and Care Research Wales (HCRW) (Health Research Authority, 2 Redman Place, Stratford, London, E20 1 JQ, United Kingdom; +44 (0)207 104 8000; bloomsbury.rec@hra.nhs.uk), ref: 25/PR/0434/AM01 |
| Health condition(s) or problem(s) studied | Pre-eclampsia |
| Intervention | Participants will enrol via the secure online REDCap platform. After consenting, they will access a structured online form with seven essential demographic and clinical questions and then a 45-item food frequency questionnaire that evaluates dietary intakes over the past month. Finally, they will then complete a 24-hour dietary recall using the MyFood24 Online Dietary Assessment Tool. This combination of online surveys will take approximately 20-25 minutes on the part of the participant. The duration of follow-up is until pregnancy outcome, which will be ascertained from clinical data. |
| Intervention type | Other |
| Primary outcome measure | 1. Ergothioneine intakes will be measured using a short, validated food frequency questionnaire, which asks participants how frequently (portions per day or week) they consumed typical foods in the last month. Ergothioneine intake will be estimated from reported consumption frequencies of ergothioneine-rich foods (e.g., mushrooms, fermented foods) using nutrient composition data. 2. Dietary quality will be measured using a short, validated Food Frequency Questionnaire (FFQ), which asks participants how frequently (portions per day or week) they consumed typical foods in the last month. Dietary quality is derived from the FFQ responses using a standardised 0–5 scoring system, where optimal intakes receive the highest score. |
| Secondary outcome measures | 1. Dietary nutrient intakes will be measured using a 24-hour dietary recall using the MyFood24 Online Dietary Assessment Tool to capture participants’ most recent nutrient intakes daily 2. Participant feedback on the usability and acceptability of the Food Frequency Questionnaire (FFQ) will be measured at the point of survey using a self-administered feedback questionnaire that combines Likert-scale and open-ended questions |
| Overall study start date | 05/01/2025 |
| Completion date | 31/03/2027 |
Eligibility
| Participant type(s) | Healthy volunteer, Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 100 |
| Key inclusion criteria | Cases: 1. Currently pregnant women, with pre-eclampsia diagnosed according to NICE guidelines (the NICE diagnostic criteria are hypertension [>140/>90 mmHg] and proteinuria/renal insufficiency/liver involvement/neurological complications/haematological complications/uteroplacental dysfunction) attending Liverpool Women’s Hospital 2. Able to consent to the study in English Controls: 1. Currently pregnant, gestationally matched women without pre-eclampsia attending Liverpool Women’s Hospital 2. Able to consent to the study in English |
| Key exclusion criteria | Cases 1. Not a patient of Liverpool Women’s Hospital 2. Unable to consent in English Controls 1. Not a patient of Liverpool Women’s Hospital 2. Unable to consent in English 3. Past medical history making them at high risk of pre-eclampsia including chronic hypertension, gestational hypertension, chronic kidney disease, autoimmune diseases 4. Previous pregnancy history making them at high risk of pre-eclampsia including fetal growth restriction, small for gestational age fetus, hypertension in pregnancy, previous pre-eclampsia 5. Current pregnancy risk factors for pre-eclampsia: PAPP-A less than 5th Centile, echogenic bowel, estimated fetal weight less than 10th centile |
| Date of first enrolment | 20/09/2025 |
| Date of final enrolment | 30/09/2026 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Crown Street
Liverpool
L8 7SS
United Kingdom
Sponsor information
University/education
Clinical Directorate
4th Floor Thompson Yates Building
Faculty of Health and Life Sciences
University of Liverpool
Liverpool
L69 3GB
England
United Kingdom
| Phone | +44 (0)151 7951780 |
|---|---|
| sponsor@liverpool.ac.uk | |
| Website | http://www.liv.ac.uk/ |
"ROR" |
https://ror.org/04xs57h96 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- The University of Liverpool, 利物浦大学, Universidad de Liverpool, UoL
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/09/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository |
| Publication and dissemination plan | The data from this study will be owned by the University of Liverpool. The findings will be shared at policy engagement meetings and national and international conferences relevant to obstetricians, midwives, nutritional scientists, and dieticians. We plan to submit the work to both the preprint server, MedRxiv, and for open access publication in an appropriate peer reviewed journal. |
| IPD sharing plan | The consent forms will be sorted in the study site file in the University of Liverpool Women and Children’s Health Research Department located at Liverpool Women’s Hospital. This will be retained in the department for 10 years. The case report forms will be identified only by the participant number and entered into the study database and stored separately until the end of the study. After this time, the de-identified, case report forms (CRFs) will be electronically scanned and uploaded into the access controlled ActiveDataStore for archiving. All electronic research data (uploaded CRFs and results of analysis) will be stored within University of Liverpool data storage infrastructure and will comply with the research data management policy researchdatamanagementpolicy.pdf (liverpool.ac.uk). All data will be password protected and accessible by the necessary members of the research team only. Data which will be used for subsequent analysis will undergo full anonymisation by decoupling of the identifiers from the data. On completion of the study, all study data including consent forms and other participant identifiable information will be stored for a minimum of 10 years. |
Editorial Notes
16/09/2025: Study's existence confirmed by the HRA.
