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An Acute Human Intervention With Flavonoid to Investigate Absorption, Metabolism and Excretion

NCT ID: NCT01922869

Last Updated: 2013-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2014-09-30

Brief Summary

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The era of general dietary recommendations for the whole population may be coming to an end, as it is becoming apparent that we are all unique and do not respond in the same way to the same foods. Within a decade it is believed that doctors will be able to take profiles of their patients, identify specific diseases for which they are at risk and create personalised nutrition plans accordingly. At the University of East Anglia, UK the investigators are interested in particular food compounds known as flavonoids which can be found in foods such as chocolate, orange juice and blackberries (COB). The study will determine if factors such as age, gender, genetics and the bacteria present in our guts contribute to variability between individuals in their absorption, metabolism and excretion of flavonoids.

Detailed Description

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The study will recruit men and women who are aged either 18-30 or 65-77 years and are generally healthy.On arriving at the study day we will collect a blood sample. Breakfast will then be supplied in the form of a food or drink that will contain freezedried powder from orange juice, chocolate and blackberry. After breakfast further blood samples will be taken at several time points throughout the day. Urine and faeces samples will also be collected. These biological samples will be tested for flavonoid absorption, metabolism and excretion as well as influence of genetic make-up of individuals and the gut microflora harboured in faecal samples.

Conditions

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Pharmacokinetics of Flavonoids in Humans

Keywords

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Absorption Metabolism Excretion Flavonoids Polyphenols Genes Gut-microflora

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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COB mixture

One time ingestion of flavonoid mixture from chocolate (80 g), orange juice (500 ml)and blackberries (160 g), also known as the 'COB mixture' providing approximately 640 mg of flavan-3-ols, 390 mg of anthocyanins and 342 mg of flavanones respectively.

Group Type EXPERIMENTAL

Flavonoids

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Flavonoids

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Male or Female
* Caucasian of European origin
* Age either between 18-30 years or between 65-77 years

Exclusion Criteria

* BMI \< 18.5 kg/m2 or BMI \> 30 kg/m2
* Smokers or nicotine users
* High (above 140/90 mmHg ) or low (less than 90/60 mmHg) blood pressure
* Having any existing medical conditions or significant past medical history likely to affect study measurements e.g., type 2 diabetes, cardiovascular, renal, liver or gastrointestinal diseases
* Unsatisfactory biochemical, haematological or urinary assessment, indicating abnormalÍž renal or liver function, full blood profile, impaired glucose handling, deranged lipids or measurements considered to be counter indicative of the study by the clinical advisor
* Taking any prescribed medication that could interact with the enzymes involved in the metabolism of flavonoids
* Taking flavonoid containing supplements or other dietary supplements for one month prior to the study (and duration of the study intervention)
* Known allergies to the intervention foods
* Consume more alcoholic beverages on average than 21 units/wk for men, or 14 units/wk for women (The UK Department of Health recommendations)
* Pregnant, breast feeding, or planning a pregnancy (or having fertility treatment)
* Unable to provide informed consent to participate in the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

77 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fred Hutchinson Cancer Center

OTHER

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role collaborator

University of East Anglia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anne-Marie Minihane, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Nutrition, University of East Anglia, Norwich, U.K.

Locations

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Department of Nutrition, University of East Anglia

Norwich, Norfolk, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Sumanto Haldar, PhD

Role: CONTACT

Phone: +44-1603591949

Email: [email protected]

Anne-Marie Minihane, PhD

Role: CONTACT

Phone: +44-1603592389

Email: [email protected]

Facility Contacts

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Ingrid Matthews

Role: primary

References

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Kay CD, Tejera N, Jennings A, Haldar S, Diment BC, Bevan D, Crossman LC, Li S, Cassidy A, Minihane AM. Effect of age and sex on the urinary elimination of a single dose of mixed flavonoids: results from a single-arm intervention in healthy United Kingdom adults. Am J Clin Nutr. 2025 Jul;122(1):101-111. doi: 10.1016/j.ajcnut.2025.05.006. Epub 2025 May 12.

Reference Type DERIVED
PMID: 40368267 (View on PubMed)

Other Identifiers

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R21072

Identifier Type: -

Identifier Source: org_study_id