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Trial registered on ANZCTR


Registration number
ACTRN12617000302358
Ethics application status
Approved
Date submitted
23/02/2017
Date registered
27/02/2017
Date last updated
8/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Short-term effects of black tea on vascular function in healthy adults
Scientific title
Short-term effects of black tea on vascular function in healthy adults
Secondary ID [1] 291267 0
None
Universal Trial Number (UTN)
U1111-1193-4680
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
endothelial function 302199 0
high blood pressure 302200 0
Condition category
Condition code
Cardiovascular 301808 301808 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
15 healthy men and women 18 to 75 years old will be recruited from the general population. Volunteers will have no history of major chronic disease.
A randomised, controlled, cross-over designed trial will be performed.
Each participant will complete 3 visits in random order. Prior to each visit participants will be asked to consume a standard meal for dinner (the night before their visit) and a low-fat breakfast (on the morning of their visit). Prior to the first visit, participants will be asked to document the meals so that they are able to repeat them for subsequent visits. For each visit participants will attend the School of Medicine and Pharmacology Research Unit at Royal Perth Hospital in the morning 2.5 hours after breakfast.
Participants will consume for 28 days, 3 cups per day (morning, during the day and afternoon/evening), of the following beverages:
1. Hot water (200 ml)
2. Black tea (2 g tea leaves infused in 200 ml)
3. Black tea with added milk (2 g tea leaves infused in 200 ml plus 20 ml of low fat [1.5%] milk)
The order of beverage consumption will be randomly assigned. There will be no washout between periods.
On the morning of each visit, participants consume 1 cup of their assigned beverage with their breakfast meal, then a second cup 1.5 hours later. One hour after this they will attend the clinic for assessments of outcomes.
All teas will be matched for total polyphenol content.
Adherence will be monitored using participant diaries, tea bag counts and measurement of biomarkers of tea-derived flavonoid exposure in urine.
Intervention code [1] 297277 0
Lifestyle
Comparator / control treatment
Participants will consume for 28 days, 3 cups per day (morning, during the day and afternoon/evening), of the following beverages:
1. Hot water (200 ml)
2. Black tea (2 g tea leaves infused in 200 ml)
3. Black tea with added milk (2 g tea leaves infused in 200 ml plus 20 ml of low fat [1.5%] milk)
The order of beverage consumption will be randomly assigned.
Control group
Active

Outcomes
Primary outcome [1] 301215 0
Primary outcome: endothelial function (flow-mediated dilation)
Flow-mediated dilation (FMD) of the brachial artery will be measured non-invasively using ultrasound. This measurement will be performed 1.5-2.0 hours after the last beverage, and again 3.0-3.5 hours after the last beverage.
A trained ultrasonographer dedicated to the research protocol and blinded to the interventions used will perform all measurements according to a published protocol. Briefly, subjects are studied in a quiet, temperature-controlled room (21 to 25 degrees Celcius) while resting in a supine position. Participants rest for 15 minutes in the supine position before initiation of FMD measurement. The left arm is extended and supported comfortably on a foam mat. ECG is monitored continuously. For the ultrasound, a 12-MHz transducer connected to an Acuson Aspen 128 ultrasound device (Acuson Corp.) is fixed in position with a clamp over the brachial artery 5 to 10 cm proximal to the antecubital crease. After a baseline artery diameter recording of 1 min, a blood pressure cuff is placed around the left forearm and inflated to 200 mm Hg. The cuff is released after 5 min, inducing reactive hyperemia. The brachial artery image is then recorded for 4 min (240 seconds) after cuff deflation to assess flow-mediated dilatation. Images are downloaded for retrospective analysis. Analysis of FMD of the brachial artery is performed with semi-automated edge detection software, which automatically calculates the brachial artery diameter, corresponding to the internal diameter. This is gated to the R wave of ECG, with measurements taken at end diastole. Responses are calculated as the percentage change in brachial artery diameter from baseline. The FMD is measured at 10 second intervals to 240 seconds after cuff deflation.
The primary outcome measure is the mean FMD between 60 seconds and 240 seconds. Analysis will also be performed using peak FMD as a secondary outcome.
Timepoint [1] 301215 0
1.5-2.0 hours after the last beverage, and again 3.0-3.5 hours after the last beverage, at the end of each intervention period (on day 28 of each period).
Secondary outcome [1] 332055 0
Secondary outcome: home blood pressure
Participants will monitor their home blood pressure in the morning, afternoon and evening each day for the last 7 days of each of the 3 intervention periods. During each 7-day home blood pressure measurement period, participants measure their blood pressure: (i) in the morning ~30 minutes after waking and prior to breakfast; (ii) in the afternoon between lunch and dinner; and (iii) in the evening ~1-2 hour after dinner. Blood pressures will be measured using an A&D Medical UA-67PC digital blood pressure monitor (A&D Instruments Ltd.). After a 5-min rest in a seated position, 5 blood pressure measurements are performed with a 1-min interval between measurements. The first reading is discarded.
Timepoint [1] 332055 0
Participants will monitor their home blood pressure in the morning, afternoon and evening each day for the last 7 days of each of the 3 intervention periods.
Secondary outcome [2] 332056 0
Secondary outcome: office blood pressure
Timepoint [2] 332056 0
Office blood pressure will be measured, following a 5 minute rest in the seated position, 5 times at 1 minute intervals, from 1 hour after the last beverage, and then each hour for 4 hours. This will be performed at the end of each 28 day intervention period (day 28).
Secondary outcome [3] 332057 0
Secondary outcome: arterial stiffness
Arterial stiffness will be assessed non-invasively using the SphygomCor pulse wave analysis system. Measurements of pulse wave velocity, central blood pressure and augmentation index will be performed at 2.0-2.5 hours after the last beverage (5 replicates). The carotid–femoral pulse wave velocity is measured after 5 min rest in a supine position by applanation tonometry using the Sphygmo- Cor pulse wave analysis system (AtCor Medical, Sydney, Australia. Model MM3. Software version 9). Before measuring pulse wave velocity, systolic and diastolic blood pressure, measured using the Dinamap PRO 100 oscillometric recorder, are entered. The ECG is recorded throughout the procedure. Pulse waves are recorded at the carotid and then femoral locations. The pulse wave velocity is calculated from measurements of pulse transit time and distance travelled by the pulse wave. The augmentation index is measured from the peripheral pulse pressure curve registered at the radial artery.
Timepoint [3] 332057 0
Measurements of pulse wave velocity, central blood pressure and augmentation index will be performed at 2.0-2.5 hours after the last beverage (5 replicates). Performed at the at the end of each intervention period (day 28).
Secondary outcome [4] 332058 0
Secondary outcome: faecal microflora
Faecal samples will be used to measure faecal microflora and will be frozen until later analysis.
Timepoint [4] 332058 0
Participants will collect a faecal sample at the end of each 28 day period period.
Secondary outcome [5] 332075 0
Secondary outcome: office heart rate
Timepoint [5] 332075 0
Office heart rate will be measured, following a 5 minute rest in the seated position, 5 times at 1 minute intervals, from 1 hour after the last beverage, and then each hour for 4 hours. Performed at the end of each 28 day intervention period.
Secondary outcome [6] 332076 0
Secondary outcome: home heart rate
Participants will monitor their home heart rate in the morning, afternoon and evening each day for the last 7 days of each of the 3 intervention periods. During each 7-day home hear rate measurement period, participants measure their heart rate: (i) in the morning ~30 minutes after waking and prior to breakfast; (ii) in the afternoon between lunch and dinner; and (iii) in the evening ~1-2 hour after dinner. Heart rate will be measured using an A&D Medical UA-67PC digital blood pressure monitor (A&D Instruments Ltd.). After a 5-min rest in a seated position, 5 heart rate measurements are performed with a 1-min interval between measurements. The first reading is discarded.
Timepoint [6] 332076 0
Participants will monitor their heart rate in the morning, afternoon and evening each day for the last 7 days of each of the 3 intervention periods.

Eligibility
Key inclusion criteria
men and women
Aged 18 to 75 years old
No history of major chronic disease.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1 current or recent (<12 months) smoking
2 body mass index < 18 or > 35 kg/m2,
3 history of cardiovascular or peripheral vascular disease,
4 diagnosed diabetes, and non-diabetic individuals with fasting plasma glucose concentrations greater than or equal to 6.5 mmol/L,
5 a psychiatric illness, or other major illnesses such as cancer,
6 current or recent (within previous 6 months) significant weight loss or gain (> 6% of body weight),
7 alcohol intake > 210 g per wk for women and > 280 g per wk for men,
8 inability or unwillingness to follow the study protocol.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size of 15 participants completing the trial has been calculated on the primary endpoint of plasma FMD. With alpha=0.01, 15 participants will provide >90% power to detect a 1% difference (a 10% difference in percentage terms) in the mean FMD between 60 and 240 seconds post ischaemia. This assumes a SD of 3% based on our previous studies, a correlation between post ischaemia measures of 0.6, a correlation between mean (60-240 second) FMD at 1.5-2.0 hours and 3.0-3.5 hours of 0.6, and a minimum of 18 FMD measures at 1.5-2.0 hours and 3.0-3.5 hours. A 1% difference in flow-mediated dilatation is substantial and clinically important.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/03/2017
Actual
2/03/2017
Date of last participant enrolment
Anticipated
3/07/2017
Actual
31/03/2017
Date of last data collection
Anticipated
29/09/2017
Actual
27/09/2017
Sample size
Target
15
Accrual to date
Final
17
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 295724 0
University
Name [1] 295724 0
University of Western Australia
Country [1] 295724 0
Australia
Primary sponsor type
Individual
Name
Jonathan Hodgson
Address
Level 4
Medical Research Foundation Building
Rear 50 Murray Street
Perth, WA 6000
Country
Australia
Secondary sponsor category [1] 294580 0
None
Name [1] 294580 0
Address [1] 294580 0
Country [1] 294580 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297027 0
University of Western Australia Human Ethics Committee
Ethics committee address [1] 297027 0
Ethics committee country [1] 297027 0
Australia
Date submitted for ethics approval [1] 297027 0
12/08/2016
Approval date [1] 297027 0
15/09/2016
Ethics approval number [1] 297027 0
RA/4/1/8566

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72754 0
Prof Jonathan Hodgson
Address 72754 0
Edith Cowan University
Level 4
Medical research Foundation Building
Rear 50 Murray Street
Perth, WA 6000
Country 72754 0
Australia
Phone 72754 0
+61 (0)8 92240267
Fax 72754 0
Email 72754 0
[email protected]
Contact person for public queries
Name 72755 0
Jonathan Hodgson
Address 72755 0
Edith Cowan University
Level 4
Medical research Foundation Building
Rear 50 Murray Street
Perth, WA 6000
Country 72755 0
Australia
Phone 72755 0
+61 (0)8 92240267
Fax 72755 0
Email 72755 0
[email protected]
Contact person for scientific queries
Name 72756 0
Jonathan Hodgson
Address 72756 0
Edith Cowan University
Level 4
Medical research Foundation Building
Rear 50 Murray Street
Perth, WA 6000
Country 72756 0
Australia
Phone 72756 0
+61 (0)8 92240267
Fax 72756 0
Email 72756 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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