Discovering markers of flavonoid intake: The Flavi-MARKER study

Not Applicable

Completed

• Conditions: Dietary biomarkers; Diet and Nutrition - Other diet and nutrition disorders

• Registration Number: ACTRN12619001553167
• Lead Sponsor: niversity of Western Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-12
• Study Completion: 2021-07-22
• Last Update Posted: 23 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

•Men and women between 18 and 75 years of age
•No prescription medications
•BMI 18.5 – 30 kg/m2
•Previously consumed cocoa, tea and apples with no adverse reactions

Exclusion Criteria

•Adults unable to consent
•Body mass index less than 18.5 or greater than 30 kg/m2
•Systolic blood pressure less than 150 mmHg
•Diastolic BP less than 100 mmHg
•Diagnosed diabetes
•Current or recent (less than 12 months) smoking
•History of cardiovascular or peripheral vascular disease
•Use of blood pressure lowering or cholesterol lowering medication
•Psychiatric illness or other major illnesses such as cancer
•Alcohol intake greater than 210 g per week for women and greater than 280 g per week for men
•Women who are lactating, pregnant or wishing to become pregnant during the study.
•Inability to attend clinic/office visits
•Use of antibiotics (within previous 3 months)
•Inability or unwillingness to follow the study protocol
•Any dietary allergies to cocoa, tea and apples or any ingredients in the standardised
meals
•GI tract disorders, previous GI surgery (except appendectomy)
•Self-reported malabsorption (e.g. difficulty digesting or absorbing nutrients from food, potentially leading to bloating, cramping or gas)
•Diarrhoea within the last 3 months
•Vegetarian, Vegan, food faddists, individuals using non-traditional diets, on a weight loss diet or individuals following diets with significant deviations from the average diet
•Currently participating in another clinical or dietary intervention study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in urinary gamma-valerolactones [24-hour urine samples will be collected, starting the morning of each intervention day. ]

Secondary Outcome Measures

Name	Time	Method
This is an exploratory outcome and a panel of urinary metabolites of phytochemical breakdown will be explored. [24-hour urine samples will be collected, starting the morning of each intervention day. ]