Abertay Tea for Cardiovascular Health During Menopause
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age45-74
SponsorAbertay University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Nutritional intervention with Fermented Seaweed Enriched English Breakfast Tea
Other interventionParticipants 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 Tea
Other interventionParticipants 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.
Treatment groups
44 Participants
are divided into 2 treatment groupsGroup A: Fermented Seaweed Enriched English Breakfast TeaExperimental treatment 1 intervention
Group B: Control TeaPlacebo comparator 1 intervention
Trial outcomes
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)
Time frame
Change from baseline at week 8Secondary outcomes
1
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.
Time frame
Change form baseline to 8 weeks2
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)
Time frame
Change from baseline at week 83
Lipoprotein levels
Serum Total Cholesterol, LDL and HDL will be measured by colorimetric assay
Time frame
Change from baseline at week 84
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
Time frame
Change from baseline at week 8Sponsors and contacts
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Source ClinicalTrials.gov