Cardiovascular Risk FactorAberTeaMNCT07070635
Abertay Tea for Cardiovascular Health During Menopause
A study testing Nutritional intervention with Fermented Seaweed Enriched English Breakfast Tea in people with Cardiovascular Risk Factor and Vascular Function, run by Abertay University at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 74 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factor, Vascular Function
- What is being tested?
- Nutritional intervention with Fermented Seaweed Enriched English Breakfast Tea
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Jun 2025to Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 74 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Abertay University
Dundee, DD1 9HG
Sarah Cottin, PhD, +44(0)1382308780, s.cottin@abertay.ac.uk
Vishnu Selvaraju, PhD
About this study
Official title: The Effect of the Fermented Seaweed Enriched Abertay Tea on Vascular Function and Markers of Cardiovascular Risk During Menopause
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.
Read the detailed description
A parallel double-blind randomised controlled trial will be run to test the effects of the AberTea (enriched with fermented seaweed) compared to a control tea on blood pressure and vascular function (primary outcomes) as well as lipoprotein profiles and glycaemic control (secondary outcomes).
Participants will be recruited through internal email circulars, posters and social media amongst Abertay students and staff, and the local community. Volunteers expressing interest will initially be sent an information sheet and a summary of the study by e-mail, with an eligibility questionnaire to fill-in. Volunteers who are eligible will then be invited to attend a short screening session (~20min) during which anthropometric measurements and fasting glucose measurements will be taken, physical activity levels, and important cofactor when examining vascular function, will be assessed using RPAQ. Volunteers who meet the inclusion criteria and sign the consent form will be enrolled in the study and will be randomly allocated to consume 3 cups of Control Tea or AberTea for 8 weeks, they will be asked to not change any other habits, including dietary and physical activity habits.
Participants will then be asked to come back to Abertay fasting for baseline (wk 0) and endpoint (wk 8) measurements. Briefly, vascular and anthropometric measurements will be performed, fasting blood samples will be taken to measure markers of cardiovascular risk, and postmenopausal symptoms will also be assessed.
On visit 1 the participants will be provided with the totality of tea bags needed for the trial (168 tea bags) plus 12 extras, i.e.180 tea bags in total. Regular calls and emails (every 2 weeks) will be maintained between the researchers and participant to ensure compliance. Compliance will be assessed via a tea log sheet provided at the start of intervention, as well as counting the tea bags leftover.
Data will be analysed by analysis of covariance (ANCOVA) of the changes from baseline values, adjusted for ethnicity, age and physical activity levels. Normality of the residuals will be checked for analysis and log transformation of the data will be attempted when required. If the residuals of the log-transformed data are still not normally distributed, non-parametrical analysis will be performed (Mann-Whitney, Kruskal-Wallis). Results will be expressed as means (SD) and changes from baseline as differences between the means with 95% confidence intervals. When data are log transformed, the results will be expressed as geometric means (SD) and the changes as ratios of the geometric means with 95% confidence intervals. All statistical analysis will be carried out with SPSS for Windows (version 29.0, SPSS, Chicago, IL) on the intention-to-treat basis.
- Conditions
- Cardiovascular Risk Factor, Vascular Function
- Being tested
- Nutritional intervention with Fermented Seaweed Enriched English Breakfast Tea, Nutritional intervention with Control English Breakfast Tea
- Keywords
- seaweed, fermented, menopause, vascular function, cardiovascular risk, continuous non invasive arterial pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional intervention with Fermented Seaweed Enriched English Breakfast TeaOther
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.
Nutritional intervention with Control English Breakfast TeaOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Fermented Seaweed Enriched English Breakfast Tea | Experimental | Nutritional intervention with English Breakfast Tea enriched with Fermented Seaweed Receives: Other: Nutritional intervention with Fermented Seaweed Enriched English Breakfast Tea |
| Control Tea | Placebo comparator | Nutritional intervention with English Breakfast Tea only Receives: Other: Nutritional intervention with Control English Breakfast Tea |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
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 arterial pressure, diastolic, mean), pulse rate, continuous non-invasive cardiac output (CO), stroke volume (SV), and systemic vascular resistance (SVR) for 15min.
Measured: Change form baseline to 8 weeks
Pulse Wave Analysis
The high sampling rate of the CNAP (100Hz) allows the detailed analysis of the pulse waves, providing indices such as the increase in amplitude caused by contraction of the myocardium (AP1), and the return of the reflected wave (AP2), the length of time required for the pulse wave to reach peak systolic pressure (TP1), peak dicrotic pressure (TP2), and the total duration of the cardiac cycle (TPT)
Measured: Change from baseline at week 8
Lipoprotein levels
Serum Total Cholesterol, LDL and HDL will be measured by colorimetric assay
Measured: Change from baseline at week 8
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Based on fasting plasma Insulin and Glucose measurements, using the following formula: [Fasting Insulin (μg/ml)]*[Fasting Glucose (mmol/l)]/22.5
Measured: Change from baseline at week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start16 Jun 2025
- Primary completionOct 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Risk FactorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abertay University
- Sponsor type
- University, hospital or other
- Collaborators
- Oshun Labs Ltd, UK Research and Innovation
- Responsible party
- Principal investigator, Sarah Cottin, Abertay University
- Investigators
- Sarah C Cottin, PhD, Principal investigator, Abertay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07070635
- Sponsor's protocol ID
- EMS9960
- Acronym
- AberTeaM
- Status last verified
- Jun 2025
- First submitted
- 11 Jun 2025
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Fermented Seaweed Enriched Abertay Tea on Vascular Function and Markers of Cardiovascular Risk During Menopause
- ClinicalTrials.gov ID
- NCT07070635
- Acronym / sponsor ID
- AberTeaM / EMS9960
- Conditions
- Cardiovascular Risk Factor, Vascular Function
- Keywords
- seaweed, fermented, menopause, vascular function, cardiovascular risk, continuous non invasive arterial pressure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Abertay UniversityUniversity, hospital or other
- Collaborators
- Oshun Labs Ltd, UK Research and Innovation
- Study start
- 16 Jun 2025 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 17 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A parallel double-blind randomised controlled trial will be run to test the effects of the AberTea (enriched with fermented seaweed) compared to a control tea on blood pressure and vascular function (primary outcomes) as well as lipoprotein profiles and glycaemic control (secondary outcomes).
Participants will be recruited through internal email circulars, posters and social media amongst Abertay students and staff, and the local community. Volunteers expressing interest will initially be sent an information sheet and a summary of the study by e-mail, with an eligibility questionnaire to fill-in. Volunteers who are eligible will then be invited to attend a short screening session (~20min) during which anthropometric measurements and fasting glucose measurements will be taken, physical activity levels, and important cofactor when examining vascular function, will be assessed using RPAQ. Volunteers who meet the inclusion criteria and sign the consent form will be enrolled in the study and will be randomly allocated to consume 3 cups of Control Tea or AberTea for 8 weeks, they will be asked to not change any other habits, including dietary and physical activity habits.
Participants will then be asked to come back to Abertay fasting for baseline (wk 0) and endpoint (wk 8) measurements. Briefly, vascular and anthropometric measurements will be performed, fasting blood samples will be taken to measure markers of cardiovascular risk, and postmenopausal symptoms will also be assessed.
On visit 1 the participants will be provided with the totality of tea bags needed for the trial (168 tea bags) plus 12 extras, i.e.180 tea bags in total. Regular calls and emails (every 2 weeks) will be maintained between the researchers and participant to ensure compliance. Compliance will be assessed via a tea log sheet provided at the start of intervention, as well as counting the tea bags leftover.
Data will be analysed by analysis of covariance (ANCOVA) of the changes from baseline values, adjusted for ethnicity, age and physical activity levels. Normality of the residuals will be checked for analysis and log transformation of the data will be attempted when required. If the residuals of the log-transformed data are still not normally distributed, non-parametrical analysis will be performed (Mann-Whitney, Kruskal-Wallis). Results will be expressed as means (SD) and changes from baseline as differences between the means with 95% confidence intervals. When data are log transformed, the results will be expressed as geometric means (SD) and the changes as ratios of the geometric means with 95% confidence intervals. All statistical analysis will be carried out with SPSS for Windows (version 29.0, SPSS, Chicago, IL) on the intention-to-treat basis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fermented Seaweed Enriched English Breakfast Tea | Experimental | Other: Nutritional intervention with Fermented Seaweed Enriched English Breakfast TeaNutritional intervention with English Breakfast Tea enriched with Fermented Seaweed |
| Control Tea | Placebo comparator | Other: Nutritional intervention with Control English Breakfast TeaNutritional intervention with English Breakfast Tea only |
Who may qualify
- Ages
- 45 to 74 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional intervention with Fermented Seaweed Enriched English Breakfast TeaParticipants 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. | Other | Fermented Seaweed Enriched English Breakfast Tea |
| Nutritional intervention with Control English Breakfast TeaParticipants 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. | Other | Control Tea |
Primary outcome
Continuous Non Invasive Arterial Blood Pressure (CNAP) measurements = Continuous Systolic Blood Pressure
Time frame: Change from baseline at week 8
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)
4 secondary outcomes
Continuous Non Invasive Arterial Blood Pressure (CNAP) measurements = Diastolic Blood Pressure, Mean Arterial Pressure and Pulse; and haemodynamic parameters
Time frame: Change form baseline to 8 weeks
Pulse Wave Analysis
Time frame: Change from baseline at week 8
Lipoprotein levels
Time frame: Change from baseline at week 8
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Time frame: Change from baseline at week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarah C Cottin, PhD principal investigator
Abertay University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional intervention with Fermented Seaweed Enriched English Breakfast Tea in people with Cardiovascular Risk Factor and Vascular Function, run by Abertay University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah C Cottin, PhD (+44(0)1382308780, s.cottin@abertay.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Continuous Non Invasive Arterial Blood Pressure (CNAP) measurements = Continuous Systolic Blood Pressure (time frame: Change from baseline at week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2025.