HealthyPhase 1NCT01790009
Influence of Age on the Absorption and Metabolism of Cocoa Flavanols
A Phase 1 study testing Flavanol rich drink and Acetaminophen in people with Healthy, run by University of Reading at 1 site in United Kingdom.
Trial summary
Accumulating evidence suggests that regular consumption of foods and beverages rich in flavanols, such as cocoa, tea, apples and wine, may have cardiovascular benefits. Several well-controlled randomised human intervention studies have shown that cocoa flavanols have beneficial effects on blood pressure, endothelial… Read more about this study
- Who is it for?
- Ages 18 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Flavanol rich drink and Acetaminophen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2011to Jun 2011
- Phase
- Phase 1
- 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 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- signed consent form
- Caucasian
- Good general health
- No allergy to milk products or sensitivity to alkaloids/caffeine,
- No gastrointestinal disorders (e.g., chronic constipation, diarrhoea, inflammatory bowel disease, irritable bowel syndrome, or other chronic gastrointestinal complaints)
- Not diabetic or suffering from hypertension (140/90 mm Hg),
- No anaemia or gall bladder problems.
Who cannot join
- those on a weight reducing dietary regimen
- Taking any dietary supplements
- Consuming more than 15 units (120g) of alcohol per week
- Taking anti-inflammatory medication
- Smokers
- Those with sensitivities to chocolate, reduced calorie sweeteners, dairy, nuts or gluten,
- Vegetarians or vegans.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Food and Nutritional Sciences
Reading, Berkshire, RG6 6AP
About this study
Accumulating evidence suggests that regular consumption of foods and beverages rich in flavanols, such as cocoa, tea, apples and wine, may have cardiovascular benefits. Several well-controlled randomised human intervention studies have shown that cocoa flavanols have beneficial effects on blood pressure, endothelial function and other biomarkers of cardiovascular health. These vascular improvements have been correlated in time with changes in plasma flavanol metabolites. The health benefits of flavanol consumption are therefore likely dependent on changes in their absorption, distribution, metabolism and excretion (ADME). Recent studies have provided detailed information regarding the absorption and metabolism of cocoa flavanols. However, there is a lack of information on whether there are changes in flavanol absorption and metabolism with increasing age.
- Conditions
- Healthy
- Being tested
- Flavanol rich drink, Acetaminophen
- Keywords
- ADME, Flavanols, Age, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flavanol rich drinkDietary supplement
Also called Comparison of two different doses of a flavanol rich drink
AcetaminophenDrug
Also called Paracetamol
2x500 mg Acetaminophen
| Study group | Role | What they receive |
|---|---|---|
| Flavanol Rich drink | Active comparator | Flavanol-rich drink containing 800 mg/75 Kg of Body Weight (BW) Receives: Dietary Supplement: Flavanol rich drink |
| Flavanol rich drink | Active comparator | Flavanol Intervention drink 400 mg/75 Kg BW Receives: Dietary Supplement: Flavanol rich drink |
| Acetaminophen | Active comparator | 2 tabletsx500 mg Receives: Drug: Acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma and urine flavanol metabolites
Measured: 24 hours
Secondary outcomes (1)
Paracetamol and methylxanthine plasma and urine levels
Measured: 24 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2013 (estimated)
- Study startFeb 2011
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeremy Paul Edward Spencer, University of Reading
- Investigators
- Jeremy Spencer, PhD, Study director, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01790009
- Sponsor's protocol ID
- FLAV-AGE01
- Status last verified
- Feb 2013
- First submitted
- 8 Feb 2013
- Last updated
- 12 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Age on the Absorption and Metabolism of Cocoa Flavanols
- ClinicalTrials.gov ID
- NCT01790009
- Acronym / sponsor ID
- FLAV-AGE01
- Conditions
- Healthy
- Keywords
- ADME, Flavanols, Age, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 12 Feb 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.
Accumulating evidence suggests that regular consumption of foods and beverages rich in flavanols, such as cocoa, tea, apples and wine, may have cardiovascular benefits. Several well-controlled randomised human intervention studies have shown that cocoa flavanols have beneficial effects on blood pressure, endothelial function and other biomarkers of cardiovascular health. These vascular improvements have been correlated in time with changes in plasma flavanol metabolites. The health benefits of flavanol consumption are therefore likely dependent on changes in their absorption, distribution, metabolism and excretion (ADME). Recent studies have provided detailed information regarding the absorption and metabolism of cocoa flavanols. However, there is a lack of information on whether there are changes in flavanol absorption and metabolism with increasing age.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Flavanol Rich drink | Active comparator | Dietary Supplement: Flavanol rich drinkFlavanol-rich drink containing 800 mg/75 Kg of Body Weight (BW) |
| Flavanol rich drink | Active comparator | Dietary Supplement: Flavanol rich drinkFlavanol Intervention drink 400 mg/75 Kg BW |
| Acetaminophen | Active comparator | Drug: Acetaminophen2 tabletsx500 mg |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- signed consent form
- Caucasian
- Good general health
- No allergy to milk products or sensitivity to alkaloids/caffeine,
- No gastrointestinal disorders (e.g., chronic constipation, diarrhoea, inflammatory bowel disease, irritable bowel syndrome, or other chronic gastrointestinal complaints)
Key exclusion criteria (7 listed)
- those on a weight reducing dietary regimen
- Taking any dietary supplements
- Consuming more than 15 units (120g) of alcohol per week
- Taking anti-inflammatory medication
- Smokers
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 |
|---|---|---|
| Flavanol rich drinkAlso: Comparison of two different doses of a flavanol rich drink | Dietary supplement | Flavanol Rich drink, Flavanol rich drink |
| AcetaminophenAlso: Paracetamol2x500 mg Acetaminophen | Drug | Acetaminophen |
Primary outcome
Plasma and urine flavanol metabolites
Time frame: 24 hours
1 secondary outcome
Paracetamol and methylxanthine plasma and urine levels
Time frame: 24 h
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2013.
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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.
Jeremy Spencer, PhD study director
University of Reading
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Flavanol rich drink and Acetaminophen in people with Healthy, run by University of Reading 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 7 inclusion and 7 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: finished, as of the sponsor's last update on 12 Feb 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma and urine flavanol metabolites (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Feb 2013.