Pharmacokinetics of Flavonoids in HumansCOBNCT01922869
An Acute Human Intervention With Flavonoid to Investigate Absorption, Metabolism and Excretion
A study testing Flavonoids in people with Pharmacokinetics of Flavonoids in Humans, run by University of East Anglia at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 77 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics of Flavonoids in Humans
- What is being tested?
- Flavonoids
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2013to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 77 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or Female
- Caucasian of European origin
- Age either between 18-30 years or between 65-77 years
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Department of Nutrition, University of East Anglia
Norwich, Norfolk, NR4 7TJ
Ingrid Matthews, +44-1603593746, i.matthews@uea.ac.uk
Anne-Marie Minihane, PhD
About this study
Official title: An Acute Flavonoid Intervention Study to Examine Influences of Genotype and Phenotype on Flavonoid Absorption, Metabolism and Excretion
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.
Read the 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.
- Conditions
- Pharmacokinetics of Flavonoids in Humans
- Being tested
- Flavonoids
- Keywords
- Absorption, Metabolism, Excretion, Flavonoids, Polyphenols, Genes, Gut-microflora
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlavonoidsDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| COB mixture | Experimental | 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. Receives: Dietary Supplement: Flavonoids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flavanoid metabolites
Concentrations of flavonoid metabolites will be assessed using state-of-the-art liquid chromatography-tandem mass spectrometry (LC-MS/MS) and quantified against commercially available standards. Serum and urine will be acidified and then extracted by solid phase extraction (SPE). Metabolite identification will be performed using a QTrap 4000 linear ion trap mass spectrometer (ABSciex, Canada) by multi-reaction monitoring (MRM) optimized for the detection of pure standards. Metabolites will be confirmed on the basis of retention time and parent-daughter ion fragmentation transitions.
Measured: 12 months
Genes involved in flavonoid metabolism
Candidate genes encoding proteins involved in the flavonoid metabolism pathway will be identified from the literature and available pathway databases such as gene ontology, gene network, KEGG. Putative functional SNPs within these genes will be identified from the literature and/or online tools such genepipe and polyphen. In addition tag SNPs will be identified across the selected genes. This approach will involve the genotyping of approximately 200 single nucleotide polymorphisms (SNPs). Genotyping of these SNPs will be performed with the MassARRAY and iPlex systems of the Sequenom genotyping platform (Sequenom, San Diego, CA), which uses the MALDITOF primer extension assay. The associations of these SNPs and flavonoid metabolism will them be investigated.
Measured: 12 months
Secondary outcomes (1)
Effect of gut microbiota on flavonoid metabolism
We will determine the effects of gut-microbiota variation on flavonoid metabolism. To do this, we will collect faecal samples and determine gut-microflora using faecal bacterial phylogenetic analysis using PCR to amplify 16S rDNA genes.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionMay 2014 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pharmacokinetics of Flavonoids in HumansStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of East Anglia
- Sponsor type
- University, hospital or other
- Collaborators
- Fred Hutchinson Cancer Center, University of Washington
- Responsible party
- Sponsor
- Investigators
- Anne-Marie Minihane, PhD, Principal investigator, Department of Nutrition, University of East Anglia, Norwich, U.K.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01922869
- Sponsor's protocol ID
- R21072
- Acronym
- COB
- Status last verified
- Aug 2013
- First submitted
- 20 Jun 2013
- Last updated
- 14 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 40368267
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Acute Flavonoid Intervention Study to Examine Influences of Genotype and Phenotype on Flavonoid Absorption, Metabolism and Excretion
- ClinicalTrials.gov ID
- NCT01922869
- Acronym / sponsor ID
- COB / R21072
- Conditions
- Pharmacokinetics of Flavonoids in Humans
- Keywords
- Absorption, Metabolism, Excretion, Flavonoids, Polyphenols, Genes, Gut-microflora
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University of East AngliaUniversity, hospital or other
- Collaborators
- Fred Hutchinson Cancer Center, University of Washington
- Study start
- Jul 2013
- Primary completion
- May 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 14 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COB mixture | Experimental | Dietary Supplement: FlavonoidsOne 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. |
Who may qualify
- Ages
- 18 to 77 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or Female
- Caucasian of European origin
- Age either between 18-30 years or between 65-77 years
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flavonoids | Dietary supplement | COB mixture |
Primary outcome
Flavanoid metabolites
Time frame: 12 months
Concentrations of flavonoid metabolites will be assessed using state-of-the-art liquid chromatography-tandem mass spectrometry (LC-MS/MS) and quantified against commercially available standards. Serum and urine will be acidified and then extracted by solid phase extraction (SPE). Metabolite identification will be performed using a QTrap 4000 linear ion trap mass spectrometer (ABSciex, Canada) by multi-reaction monitoring (MRM) optimized for the detection of pure standards. Metabolites will be confirmed on the basis of retention time and parent-daughter ion fragmentation transitions.
Genes involved in flavonoid metabolism
Time frame: 12 months
Candidate genes encoding proteins involved in the flavonoid metabolism pathway will be identified from the literature and available pathway databases such as gene ontology, gene network, KEGG. Putative functional SNPs within these genes will be identified from the literature and/or online tools such genepipe and polyphen. In addition tag SNPs will be identified across the selected genes. This approach will involve the genotyping of approximately 200 single nucleotide polymorphisms (SNPs). Genotyping of these SNPs will be performed with the MassARRAY and iPlex systems of the Sequenom genotyping platform (Sequenom, San Diego, CA), which uses the MALDITOF primer extension assay. The associations of these SNPs and flavonoid metabolism will them be investigated.
1 secondary outcome
Effect of gut microbiota on flavonoid metabolism
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2013.
- Derived from this study: PubMed 40368267Kay 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne-Marie Minihane, PhD principal investigator
Department of Nutrition, University of East Anglia, Norwich, U.K.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flavonoids in people with Pharmacokinetics of Flavonoids in Humans, run by University of East Anglia at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sumanto Haldar, PhD (+44-1603591949, S.Haldar@uea.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flavanoid metabolites (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01922869, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2013.