Clinical trial NCT01922869: An Acute Human Intervention With Flavonoid to Investigate Absorption, Metabolism and Excretion
Official title: An Acute Flavonoid Intervention Study to Examine Influences of Genotype and Phenotype on Flavonoid Absorption, Metabolism and Excretion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pharmacokinetics of Flavonoids in Humans
Keywords: Absorption
Metabolism
Excretion
Flavonoids
Polyphenols
Genes
Gut-microflora
Lead sponsor: University of East Anglia
Sponsor class: OTHER
Collaborators: name: Fred Hutchinson Cancer Center
name: University of Washington
First posted: 2013-08-14
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 77
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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: 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.

Eligibility criteria: 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 abnormal; 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

Primary outcomes:
measure: Flavanoid metabolites
timeFrame: 12 months
measure: Genes involved in flavonoid metabolism
timeFrame: 12 months
Secondary outcomes:
measure: Effect of gut microbiota on flavonoid metabolism
timeFrame: 18 months
Other outcomes:
Locations:
city: Norwich
country: United Kingdom
facility: Department of Nutrition, University of East Anglia
state: Norfolk
Study officials:
affiliation: Department of Nutrition, University of East Anglia, Norwich, U.K.
name: Anne-Marie Minihane, PhD
role: PRINCIPAL_INVESTIGATOR
References: