Abertay Tea for Cardiovascular Health During Menopause

NCT07070635 | Recruiting

• 1 other identifier: EMS9960
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The regular consumption of seaweed, as observed in Japan, is associated to a reduced cardiovascular risk and prolonged life expectancy. Interventional studies have shown that brown seaweed consumption can reduce blood pressure, improve glycaemic control and lipoprotein profiles, although this varies with population, dose, duration and the type of seaweed. Brown seaweed appears the most promising to improve cardiovascular risk, due to the presence of specific antioxidants (polyphenols called phlorotannins), pigments (fucoxanthin) and fibre (alginate, fucoidan). Women see their cardiovascular risk greatly increased when they reach menopause, and seaweed consumption may provide benefits for this population. In the UK, 98% of UK residents drink tea daily (Source UKTIA), with English breakfast tea being the most popular. Providing a tea enriched with beneficial compounds has the potential to improve cardiovascular health in a wide range of the population, including postmenopausal women. Abertay university (Dundee, UK) has recently developed an English Breakfast tea enriched with fermented seaweed, which was found to taste like English breakfast tea. We hypothesise that the consumption of 3 cups a day of the Abertay-developed Tea (AberTea) for 8 weeks, with each tea bag containing 1g of fermented seaweed, will improve vascular function and cardiovascular risk factors in postmenopausal women.

Conditions

Cardiovascular Risk Factor; Vascular Function

Keywords

seaweed; fermented; menopause; vascular function; cardiovascular risk; continuous non invasive arterial pressure

Outcome Measures

Primary Outcomes (1)

• Continuous Non Invasive Arterial Blood Pressure (CNAP) measurements = Continuous Systolic Blood Pressure

  All the non-invasive vascular measurements will be performed in the seated position on the non-dominant arm. The participant will be given a minimum of 5 min rest, time during which a continuous non invasive arterial pressure (CNAP®) monitor will be fitted on their arm and fingers as per the manufacturer's instructions. The participant will be asked to remain as relaxed and calm as possible, so their left arm remains still during the measurements. After 5 min rest, a brachial calibration will be performed, followed by the concomitant measurements of CNAP (continuous non-invasive systolic arterial pressure)

  Change from baseline at week 8

Secondary Outcomes (4)

• Continuous Non Invasive Arterial Blood Pressure (CNAP) measurements = Diastolic Blood Pressure, Mean Arterial Pressure and Pulse; and haemodynamic parameters

  Change form baseline to 8 weeks

• Pulse Wave Analysis

  Change from baseline at week 8

• Lipoprotein levels

  Change from baseline at week 8

• Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)

  Change from baseline at week 8

Study Arms (2)

Fermented Seaweed Enriched English Breakfast Tea

EXPERIMENTAL

Nutritional intervention with English Breakfast Tea enriched with Fermented Seaweed

Other: Nutritional intervention with Fermented Seaweed Enriched English Breakfast Tea

Control Tea

PLACEBO COMPARATOR

Nutritional intervention with English Breakfast Tea only

Other: Nutritional intervention with Control English Breakfast Tea

Interventions

Nutritional intervention with Fermented Seaweed Enriched English Breakfast Tea OTHER

Participants will consume 3 cups of tea per day - spread out during the day, for 8 weeks. For each cup, they will be asked to briefly stir one tea bag (3g tea + 1 g fermented seaweed) into 250mL boiling water and let it brew for 3minutes, before removing the tea bag without squeezing it.

Fermented Seaweed Enriched English Breakfast Tea

Nutritional intervention with Control English Breakfast Tea OTHER

Participants will consume 3 cups of tea per day - spread out during the day, for 8 weeks. For each cup, they will be asked to briefly stir one tea bag (3g tea) into 250mL boiling water and let it brew for 3minutes, before removing the tea bag without squeezing it.

Control Tea

Eligibility Criteria

• Age: 45 Years - 74 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal status: no menstrual period over the last 12 months
• Regular tea drinkers (at least once a week), willingness to consume 3 cups of English breakfast tea per day for 8 weeks
• BMI between 18.5 and 39.99 kg/m2

You may not qualify if:

• Reported history of CVD (myocardial infarction, angina, venous thrombosis, stroke, dyslipidemia), diabetes (or fasting glucose ≥ 6.1 mmol/L), kidney, liver or bowel disease.
• Recent history of cancer (\<1y)
• History indicative of a congenital or acquired platelet or haemostatic defect.
• Presence of gastrointestinal disorder or use of drug, which is likely to alter gastrointestinal motility or nutrient absorption.
• Recent use of hypolipidaemic, antiplatelet or antithrombotic medications
• Impairment of thyroid function
• Current smokers or vapers
• Current self-reported weekly alcohol intake exceeding 14 units
• Current or recent use of hormone replacement therapy (\<3 months)
• Recent participation in another clinical trial (\<3 months)
• Allergy or intolerance to crustaceans or iodine

Sponsors & Collaborators

• Abertay University: lead
• Oshun Labs Ltd: collaborator
• UK Research and Innovation: collaborator

Study Sites (1)

Abertay University

Dundee, DD1 9HG, United Kingdom

RECRUITING

Study Officials

• Sarah C Cottin, PhD

  Abertay University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah C Cottin, PhD

CONTACT

+44(0)1382308780; s.cottin@abertay.ac.uk

Vishnu Selvaraju, PhD

CONTACT

+44(0)1382308212; teastudy@abertay.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer in Nutritional Sciences

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: July 17, 2025
• Study Start: June 16, 2025
• Primary Completion: October 1, 2025
• Study Completion: November 1, 2025
• Last Updated: July 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)