- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01922869
An Acute Human Intervention With Flavonoid to Investigate Absorption, Metabolism and Excretion (COB)
August 12, 2013 updated by: University of East Anglia
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
240
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sumanto Haldar, PhD
- Phone Number: +44-1603591949
- Email: S.Haldar@uea.ac.uk
Study Contact Backup
- Name: Anne-Marie Minihane, PhD
- Phone Number: +44-1603592389
- Email: A.Minihane@uea.ac.uk
Study Locations
-
-
Norfolk
-
Norwich, Norfolk, United Kingdom, NR4 7TJ
- Recruiting
- Department of Nutrition, University of East Anglia
-
Contact:
- Ingrid Matthews
- Phone Number: +44-1603593746
- Email: i.matthews@uea.ac.uk
-
Principal Investigator:
- Anne-Marie Minihane, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 77 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
12 months
|
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.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effect of gut microbiota on flavonoid metabolism
Time Frame: 18 months
|
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.
|
18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Anne-Marie Minihane, PhD, Department of Nutrition, University of East Anglia, Norwich, U.K.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2013
Primary Completion (ANTICIPATED)
May 1, 2014
Study Completion (ANTICIPATED)
September 1, 2014
Study Registration Dates
First Submitted
June 20, 2013
First Submitted That Met QC Criteria
August 12, 2013
First Posted (ESTIMATE)
August 14, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
August 14, 2013
Last Update Submitted That Met QC Criteria
August 12, 2013
Last Verified
August 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- R21072
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pharmacokinetics of Flavonoids in Humans
-
University of Texas Southwestern Medical CenterNational Center for Complementary and Integrative Health (NCCIH)Completedthe Pharmacokinetic Profile of Icariin in HumansUnited States
-
Mentis CuraThe Icelandic Center for ResearchCompletedStability of EEG Features in Humans
-
University of ZurichCompletedAltered Waking States of Consciousness in Healthy HumansSwitzerland
-
Catabasis PharmaceuticalsCompletedAssessment of Mechanistic Blood Biomarkers in Healthy HumansUnited States
-
Boston University Charles River CampusRecruitingLarge-scale Physiological Foundations of Memory Decline in Aging HumansUnited States
-
Loma Linda UniversityCompletedFocus: Effect of Muscle Activation on CMAP in Normal HumansUnited States
-
University of ZurichCompleted
-
Children's Hospital of Eastern OntarioRecruitingPharmacokinetics of Celecoxib in ChildrenCanada
-
Jazz PharmaceuticalsCompletedEvaluation of Pharmacokinetics of Sativex in the Absence and Presence of a Known Inducer of CYP3A4 | Evaluation of Pharmacokinetics of Sativex in the Absence and Presence of a Potent Inhibitor of CYP3A4 | Evaluation of Pharmacokinetics of Sativex in the Absence and Presence of a CYP2C19...United Kingdom
-
National Council of Scientific and Technical Research...Medical School HamburgRecruitingBrain Response Evoked by Radiofrequency Stimuli in Humans | Brain Response Evoked by Pinprick Stimuli in HumansArgentina
Clinical Trials on Flavonoids
-
National Polytechnic Institute, MexicoCompletedFrail Elderly Syndrome | Sarcopenia
-
Instituto Nacional de Perinatologia Isidro Espinosa...National Polytechnic Institute, MexicoNot yet recruitingMetabolic SyndromeMexico
-
Texas Tech University Health Sciences CenterWithdrawnDiabetic Nephropathy | Endothelial DysfunctionUnited States
-
Utah State UniversityCompletedInflammation | Metabolic Syndrome XUnited States
-
Guillermo Ceballos ReyesInstituto de Seguridad y Servicios Sociales de los Trabajadores del EstadoRecruitingFatigue Syndrome, Chronic | Long Covid19Mexico
-
Capital Medical UniversityXinjiang Uygur Pharmaceutical Co., Ltd.RecruitingAlzheimer DiseaseChina
-
PharmanexUtah State UniversityCompletedHealthyUnited States
-
Xinjiang Uygur Pharmaceutical Co., Ltd.Chinese Academy of SciencesUnknown
-
Quadram Institute BioscienceEuropean UnionCompleted
-
Giellepi S.p.AOpera CRO, a TIGERMED Group CompanyNot yet recruiting