Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001202358
Ethics application status
Approved
Date submitted
9/08/2017
Date registered
16/08/2017
Date last updated
9/10/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of a flavonoid food additive on blood vessel function
Scientific title
Acute effect of EMIQ (Enzymatically Modified IsoQuercetin) on endothelial function, blood pressure stress response and oxidative stress in adults with at least one cardiovascular risk factor.
Secondary ID [1] 292624 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
high blood pressure 304315 0
high cholesterol 304351 0
high blood sugar 304352 0
obesity 304353 0
Condition category
Condition code
Cardiovascular 303670 303670 0 0
Hypertension
Cardiovascular 303691 303691 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
EMIQ at a single dose of 2 mg/ kg body weight or placebo control. Treatment dissolved in water and taken orally. wash out period between treatments is 1 week.
Intervention code [1] 298847 0
Treatment: Other
Comparator / control treatment
The EMIQ treatment will be given with 1 gram of maltodextrin carrier dissolved in 200 ml of water. The control will be 1 gram of maltodextrin alone dissolved in 200 ml of water.
Control group
Placebo

Outcomes
Primary outcome [1] 303035 0
Vascular function assessed by flow mediated dilation of the brachial artery (FMD) using non-invasive ultrasound.
Timepoint [1] 303035 0
2 hours post dose
Secondary outcome [1] 337729 0
Blood pressure response to cognitive stress. BP measured every 2 mins using a Dynamap oscillometric device . Cognitive stress testing uses a computerized Cognitive Demand Battery. The cognitive task will be of a mathematical nature.
Timepoint [1] 337729 0
2 hours post dose
Secondary outcome [2] 337730 0
oxidative stress will be determined by measuring plasma F2-isoprostanes using mass specytrometry
Timepoint [2] 337730 0
+ 2 hours post dose

Eligibility
Key inclusion criteria
Otherwise healthy volunteers with one of the following:
slightly elevated BP (systolic more than 120 but less than 160 mmHg)
Blood sugar (glucose more than 5.6 but less than 6.5 mmol/L)
Blood cholesterol (total cholesterol more than 5 mmol/L but less than 8 mmol/L)
Central obesity ( men, waist circumference greater than 94 cm; women greater than 80 cm)
Minimum age
50 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Taking prescribed medication for high BP, Lipids or diabetes.
Current or recent (< 12 months) smoking
• Body mass index less than 18 or more than 35 kg/m2
• History of cardiovascular or peripheral vascular disease
• A systolic blood pressure less than 100 or more than 160 mmHg.
• A diastolic blood pressure less than 50 or more than 90 mmHg
• Diagnosed diabetes, and non-diabetic individuals with fasting plasma glucose concentrations more than 6.5 mmol/L
• A psychiatric illness
• Other major illnesses such as cancer
• Current or recent (within previous 6 months) significant weight loss or gain (>6% of body weight) or actively trying to lose weight
• Alcohol intake > 210g per week for women and > 280 g per week for men
• Women who are lactating, pregnant or wishing to become pregnant during the study.

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)
numbered containers
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary outcome measure in this study is a measurement of blood vessel function by non-invasive ultrasound (flow-mediated dilation of the brachial artery). Our research team has considerable experience with the use of this technique. Using data from several of our previous trials we expect that the standard deviation for the measurement of flow-mediated dilation of the brachial artery will be approximately 2%. A sample of 25 participants (with paired comparisons) will provide greater than 90% power to detect a 1.5% difference in flow-mediated dilation between control (maltodextrin only) and EMIQ(140 mg quercetin equivalents for a 70 kg person). That is, if the true difference in the mean response is greater than or equal to 1.5%, we will be able to reject the null hypothesis that this response difference is zero with probability (power) greater than 0.9.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
16/10/2017
Actual
Date of last participant enrolment
Anticipated
30/06/2018
Actual
Date of last data collection
Anticipated
31/08/2018
Actual
Sample size
Target
25
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 8749 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 16869 0
6000 - Perth

Funding & Sponsors
Funding source category [1] 297253 0
Commercial sector/Industry
Name [1] 297253 0
San-Ei Gen F.F.I.
Country [1] 297253 0
Japan
Primary sponsor type
University
Name
University of Western Australia
Address
35 Stirling Highway
Crawley, Western Australia , 6009
Country
Australia
Secondary sponsor category [1] 296224 0
Commercial sector/Industry
Name [1] 296224 0
San-Ei Gen F.F.I.
Address [1] 296224 0
1-1-11, Toyonaka
Osaka, 561-8588 Japan
Country [1] 296224 0
Japan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298372 0
University of Western Australia Ethics Committee
Ethics committee address [1] 298372 0
Stirling Highway, Crawley,
Western Australia, 6009
Ethics committee country [1] 298372 0
Australia
Date submitted for ethics approval [1] 298372 0
07/07/2017
Approval date [1] 298372 0
16/08/2017
Ethics approval number [1] 298372 0
RA/4/1/9260

Summary
Brief summary
This study aims to determine if acute ingestion of EMIQ, a dietary flavonoid, can improve blood vessel function and blood pressure stress response in human volunteers. We will investigate the biochemical mechanism of any beneficial effects via the measurement of plasma levels of nitrate, nitrite and biomarkers of vascular function and oxidative stress.
We hypothesize that EMIQ will improve vascular function and moderate the BP response to stress.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76862 0
Prof Kevin Croft
Address 76862 0
School of Biomedical Science
University of WA
GPO Box X2213, Perth, WA 6847
Country 76862 0
Australia
Phone 76862 0
+61 8 92240275
Fax 76862 0
Email 76862 0
kevin.croft@uwa.edu.au
Contact person for public queries
Name 76863 0
Ms Nicky Bondonno
Address 76863 0
University of Western Australia
level 3, Medical Research Foundation Building
50 Murray street, Perth, 6000
WA
Country 76863 0
Australia
Phone 76863 0
+61 8 92240342
Fax 76863 0
Email 76863 0
nicola.bondonno@uwa.edu.au
Contact person for scientific queries
Name 76864 0
Prof Kevin Croft
Address 76864 0
School of Biomedical Science
University of WA
GPO Box X2213, Perth, WA 6847
Country 76864 0
Australia
Phone 76864 0
+61 8 92240275
Fax 76864 0
Email 76864 0
kevin.croft@uwa.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEnzymatically modified isoquercitrin improves endothelial function in volunteers at risk of cardiovascular disease.2020https://dx.doi.org/10.1017/S0007114519002137
N.B. These documents automatically identified may not have been verified by the study sponsor.