Trial from ANZCTR


Trial ID ACTRN12607000543482
Trial Status: Registered
Date Submitted: 19/10/2007
Date Registered: 23/10/2007
Prospectively registered

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Public title Long-term effects of regular consumption of tea-derived flavonoids on endothelial function, blood pressure and cardiovascular disease risk: a randomized controlled trial
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format Long-term effects of regular consumption of tea-derived flavonoids on endothelial function, blood pressure and cardiovascular disease risk: a randomized controlled trial
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UTN
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Trial acronym
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Health condition(s) or problem(s) studied:
Cardiovascular disease 2477 0
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Condition category: Condition code:
Cardiovascular Diseases of the vasculature and circulation including the lymphatic system
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2578 2578 0 0
Diet and nutrition Other diet and nutrition disorders
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2579 2579 0 0

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Descriptions of intervention(s) / exposure This is a randomised double-blind, controlled, parallel-designed study. Participants will be randomly assigned to either increased flavonoid intake (~450 mg/d) from a flavonoid-rich black tea beverage, or to no increase in flavonoid intake using a tea-flavoured control beverage without flavonoids. The study will be performed over an 18 month period, with each participant being involved in a 6 month intervention.
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Intervention Code:
Other interventions 2207 0
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Comparator / control treatment Participants will be randomly assigned to either increased flavonoid intake (~450 mg/d) from a flavonoid-rich black tea beverage, or to no increase in flavonoid intake using a tea-flavoured control beverage without flavonoids.
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Control group Placebo
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Primary Outcome: Endothelial function (Brachial artery flow-mediated dilatation assessed using ultrasound measurement) 3485 0
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Timepoint: At baseline, 3 months and 6 months 3485 0
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Primary Outcome: 24 hour ambulatory blood pressure. 3486 0
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Timepoint: At baseline, 3 months and 6 months 3486 0
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Secondary Outcome: Fasting serum total cholesterol, low density lipoprotein cholesterol, high density lipoprotein cholesterol and triglycerides using routine methods within the core clinical laroratory at Royal Perth Hospital. 5817 0
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Timepoint: At baseline, 3 months and 6 months 5817 0
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Secondary Outcome: Fasting serum glucose and insulin using routine methods within the core clinical laroratory at Royal Perth Hospital 5818 0
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Timepoint: At baseline, 3 months and 6 months 5818 0
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Secondary Outcome: Fasting plasma total homocysteine using an immunoassay within the core clinical laroratory at Royal Perth Hospital 5819 0
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Timepoint: At baseline, 3 months and 6 months 5819 0
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Secondary Outcome: Plasma F2-isoprostanes measured using gas chromatography-mass spectrometry 5820 0
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Timepoint: At baseline, 3 months and 6 months 5820 0
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Secondary Outcome: 24 hour urinary nitrite and nitrate excretion 5821 0
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Timepoint: At baseline, 3 months and 6 months 5821 0
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Secondary Outcome: 24 hour urinary 4-O-methylgallic acid excretion 5822 0
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Timepoint: At baseline, 3 months and 6 months 5822 0
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Key inclusion criteria Age at start of the study > 35 and < 75 years.
Body Mass Index (BMI) >19 and < 35 kg/m2.
4 hour day time ambulatory systolic blood pressure >120 and < 151 mmHg, and ambulatory diastolic blood pressure < 100 mmHg at screening visit.
No use of supplements 4 weeks prior to and during the study.
Haematology within the normal reference range.
Total cholesterol < 6.5 mmol/L, plasma creatinine and liver enzymes within normal reference range.
Fasting blood glucose < 6.5 mmol/L and potassium within normal reference range.
Willing to replace use of aspirin and aspirin-like painkillers (e.g. Ibuprofen) by paracetamol 4 weeks prior to and during the study.
Agreeing to be informed about medically relevant personal test-results.
Having access to a general practitioner (GP).
Informed consent signed.
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Minimum age 35 Years
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Maximum age 75 Years
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Gender Both males and females
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Healthy volunteers? Yes
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Key exclusion criteria Being an employee or student of the University of Western Australia.
A recorded history or current diabetes or a recorded history of metabolic diseases, chronic gastrointestinal disorders, cardiovascular, malignancies, renal disease or psychiatric disorders.
Currently on a medically prescribed diet, or slimming diet or actively trying to lose weight.
Subjects with pulse <50 or >100 beats per minute.
Reported intense sporting activities > 10 hours per week.
Subjects who are taking more than three different classes of antihypertensive medications or who take anti-hypertensive medication that may effect the bioavailability of the test products and not able or willing to stop taking them.
Use of systemic antibiotics in the period of 1 month prior to the study.
Reported intolerance or allergy to test products.
Reported lactating, pregnant or wishing to become pregnant during the study.
Reported weight change ± 10% during a period of 6 months prior to the study.
Alcohol intake > 200 g alcohol/wk for women and > 300 g alcohol/wk for men.
Combined tea and coffee intake < than 2 cups per day.
Reported participation in another biomedical study 3 months before the start or during the study.
The habit of smoking cigarettes during the past year.
Reported participation in night shift work during the study period.
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Study type Interventional
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Purpose of the study Treatment
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Allocation to intervention Randomised controlled trial
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Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures) Eligible individuals will be randomly assigned 1:1 using computer generated random numbers to either the high-flavonoids tea group or the control group. Randomisation will be according to a bolck design and according to gender. Study products will be labelled with 10 different randomly generated numbers of 4 digits (5 linked to placebo and 5 linked to active). This will prevent participants from finding out what product they are consuming by talking to each other. This will also help to keep the people doing the measurements blinded. 100 envelopes, numbered 1-100, will each contain one of those 4 digit numbers (50 linking to placebo, 50 linking to active). These envelopes will be used for randomisation by opening an envelope, in consecutive order, as participants are entered into the study. These envelopes will be held by an independent person within the Univesity of Western Australia. The study coordinator will contact the independent person to obtain the next available envelope once an individual is deemed eligible. The envelope will be opened and code will be recorded.
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Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation) Computer-generated random numbers using Microsoft Excel.
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Masking / blinding Blinded (masking used)
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Who is / are masked / blinded (choose all that apply)


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Assignment Parallel
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Other design features
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Type of endpoint(s) Efficacy
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Statistical Methods/Analysis
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Phase Not Applicable
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Anticipated date of first participant enrolment 1/12/2007
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Date of first participant enrolment
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Anticipated date last participant recruited/enrolled
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Actual date last participant recruited/enrolled
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Target sample size 100
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Recruitment status Recruiting
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Recruitment in Australia

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Recruitment outside Australia

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Funding Source: Commercial sector/Industry 2733 0
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Name: Unilever 2733 0
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Address: Unilever Research and Development
Vlaardingen B.V., Oliver van Noortlaan 120, 3133 AT Vlaardingen
2733 0
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Country: Netherlands 2733 0
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Funding Source: Government body 2734 0
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Name: National Health & Medical Research Council 2734 0
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Address: Canberra 2734 0
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Country: Australia 2734 0
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Primary Sponsor University
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Name: Univeristy of Western Australia
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Address: Stirling Highway
Crawley, WA
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Country: Australia
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Secondary Sponsor: None 2469 0
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Name: 2469 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: University of Western Australia Human Research Ethics Committee 4650 0
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Address: Stirling Highway
Crawley, WA
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Country: Australia 4650 0
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Approval Date: 4650 0
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Submitted Date: 19/09/2007 4650 0
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HREC: RA/4/1/1917 4650 0
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Brief summary The primary objective of this trial is to assess whether long term consumption of black tea results in increased endothelium-dependent flow-mediated dilatation of the brachial artery and a decreased 24-hour ambulatory blood pressure. Efeects on other cardiovascular disease-related measurements will also be assessed.
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Trial website
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Public Notes
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Principal Investigator
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Contact person for public queries
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Name: Dr Jonathan Hodgson
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Address: School of Medicine and Pharmacology GPO Box X2213 Perth 6847
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Tel: 61 (0)8 9224 0267
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Email: Jonathan.Hodgson@uwa.edu.au
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Contact person for scientific queries
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Name: Dr Jonathan Hodgson
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Address: School of Medicine and Pharmacology GPO Box X2213 Perth 6847
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Contact person responsible for updating information
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Name: Dr Jonathan Hodgson
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Address: School of Medicine and Pharmacology GPO Box X2213 Perth 6847
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Country: Australia
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Addition Cancer fields
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