The effect of a flavonoid food additive on blood vessel function

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.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12617001202358

Enrollment

Registered

2017-08-16

Start date

2017-10-16

Completion date

2018-06-30

Last updated

2017-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

50 Years to 75 Years

Healthy volunteers

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)

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.

Outcome results