Abertay Tea for Cardiovascular Health During Menopause

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.

Inclusion criteria

• 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

Exclusion criteria

• 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