Ignite Creation Date:
2025-12-24 @ 10:30 PM
Ignite Modification Date:
2026-01-01 @ 8:28 AM
Study NCT ID:
NCT07070635
Status:
RECRUITING
Last Update Posted:
2025-07-17
First Post:
2025-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Abertay Tea for Cardiovascular Health During Menopause
Sponsor:
Abertay University
Organization:
Study Overview
Official Title:
The Effect of the Fermented Seaweed Enriched Abertay Tea on Vascular Function and Markers of Cardiovascular Risk During Menopause
Status:
RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AberTeaM
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: