HealthyNCT02789761
The Vascular and Cognitive Effects of Chronic High-flavanol Intake in Healthy Males
A study testing High-flavanol milk choocolate and Low-flavanol milk chocolate in people with Healthy, run by University of Reading.
Trial summary
A randomised, placebo-controlled, parallel human dietary intervention trial conducted in 33 healthy males to investigate the vascular and cognitive effects of bi-daily consumption of high-flavanol (epicatechin-rich) milk chocolate over a 2-week intervention period. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- High-flavanol milk choocolate and Low-flavanol milk chocolate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Jun 2016
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body Mass Index 18.5-27.5 kg/m2
- Normal Blood pressure (< 150/90)
- Non-smoker
- Regular exercise routine
- Signed consent form
Who cannot join
- Haemoglobin (anaemia marker) < 125 g/l
- Gamma GT (liver enzymes) > 80 IU/l
- Total Cholesterol > 6.5 mmol/l
- Suffered a myocardial infarction or stroke in the last 12 months
- Suffers from any cardiovascular or metabolic disorders
- Suffers from any blood-clotting disorder, and/or takes supporting medication
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- Any dietary restrictions or on a weight reducing diet
- On any lipid-modifying or blood pressure lowering medication
- Consuming any specific vitamin/ herbal supplements or fish oils
About this study
A randomised, placebo-controlled, parallel human dietary intervention trial conducted in 33 healthy males to investigate the vascular and cognitive effects of bi-daily consumption of high-flavanol (epicatechin-rich) milk chocolate over a 2-week intervention period. Subjects visited the Hugh Sinclair Unit of Human Nutrition on 3 separate occasions; at the beginning, end and post-intervention.
- Conditions
- Healthy
- Being tested
- High-flavanol milk choocolate, Low-flavanol milk chocolate
- Keywords
- Flow-mediated dilatation (FMD), Vascular function, cognitive function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-flavanol milk choocolateDietary supplement
Also called Epicatechin-rich milk chocolate
Low-flavanol milk chocolateDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| High-flavanol milk chocolate | Active comparator | Bi-daily consumption of 12 g portion of a high-flavanol milk chocolate containing approximately 35 mg of (-)-epicatechin for 2-weeks (14 days) Receives: Dietary Supplement: High-flavanol milk choocolate |
| Low-flavanol milk chocolate | Placebo comparator | Bi-daily consumption of 12 g portion of a low-flavanol milk chocolate containing approximately <1 mg of (-)-epicatechin for 2-weeks (14 days) Receives: Dietary Supplement: Low-flavanol milk chocolate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow-mediated Dilation (FMD)
Ultrasound-based assessment of brachial artery reactivity following induced reactive hyperemia
Measured: Change from baseline at 14 days
Secondary outcomes (7)
Blood pressure (BP)
Acute assessment of systolic and diastolic BP (3 repeats)
Measured: Change from baseline at 14 days
Executive Function
Assessed by cognitive test battery
Measured: Change from baseline at 14 days
Endothelial progenitor cells and Microparticles
Flow cytometric analysis using whole blood
Measured: Change from baseline at 14 days
Plasma flavanol metabolite analysis
HPLC-MS assessment of metabolite profile and content of plasma
Measured: Change from baseline at 14 days
Plasma Nitrite & Nitrate analysis
HPLC-based system with inbuilt colorimetric Griess reaction assay for the assessment of Nitrite \& Nitrate in plasma
Measured: Change from baseline at 14 days
Serum analysis of cardivascular-related blood marker(s) concentration
ILAB assessment of serum content of glucose, Triglycerides, total cholesterol, HDL-cholesterol, C-reactive protein and Non-esterified fatty acids
Measured: Change from baseline at 14 days
Serum analysis of insulin
ELIZA kits for determination of insulin concentration in serum
Measured: Change from baseline at 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2016 (estimated)
- Study startJan 2016
- Primary completionJun 2016 (estimated)
- Study completionJun 2016 (estimated)
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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 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 P Spencer, PhD, Principal investigator, Univerisity of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02789761
- Sponsor's protocol ID
- MCStudy
- Status last verified
- May 2016
- First submitted
- 25 Apr 2016
- Last updated
- 3 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Vascular and Cognitive Effects of Chronic High-flavanol Intake in Healthy Males
- ClinicalTrials.gov ID
- NCT02789761
- Acronym / sponsor ID
- MCStudy
- Conditions
- Healthy
- Keywords
- Flow-mediated dilatation (FMD), Vascular function, cognitive function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 3 Jun 2016 (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.
A randomised, placebo-controlled, parallel human dietary intervention trial conducted in 33 healthy males to investigate the vascular and cognitive effects of bi-daily consumption of high-flavanol (epicatechin-rich) milk chocolate over a 2-week intervention period. Subjects visited the Hugh Sinclair Unit of Human Nutrition on 3 separate occasions; at the beginning, end and post-intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-flavanol milk chocolate | Active comparator | Dietary Supplement: High-flavanol milk choocolateBi-daily consumption of 12 g portion of a high-flavanol milk chocolate containing approximately 35 mg of (-)-epicatechin for 2-weeks (14 days) |
| Low-flavanol milk chocolate | Placebo comparator | Dietary Supplement: Low-flavanol milk chocolateBi-daily consumption of 12 g portion of a low-flavanol milk chocolate containing approximately <1 mg of (-)-epicatechin for 2-weeks (14 days) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Body Mass Index 18.5-27.5 kg/m2
- Normal Blood pressure (< 150/90)
- Non-smoker
- Regular exercise routine
- Signed consent form
Key exclusion criteria (9 listed)
- Haemoglobin (anaemia marker) < 125 g/l
- Gamma GT (liver enzymes) > 80 IU/l
- Total Cholesterol > 6.5 mmol/l
- Suffered a myocardial infarction or stroke in the last 12 months
- Suffers from any cardiovascular or metabolic disorders
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 |
|---|---|---|
| High-flavanol milk choocolateAlso: Epicatechin-rich milk chocolate | Dietary supplement | High-flavanol milk chocolate |
| Low-flavanol milk chocolate | Dietary supplement | Low-flavanol milk chocolate |
Primary outcome
Flow-mediated Dilation (FMD)
Time frame: Change from baseline at 14 days
Ultrasound-based assessment of brachial artery reactivity following induced reactive hyperemia
7 secondary outcomes
Blood pressure (BP)
Time frame: Change from baseline at 14 days
Executive Function
Time frame: Change from baseline at 14 days
Endothelial progenitor cells and Microparticles
Time frame: Change from baseline at 14 days
Plasma flavanol metabolite analysis
Time frame: Change from baseline at 14 days
Plasma Nitrite & Nitrate analysis
Time frame: Change from baseline at 14 days
Serum analysis of cardivascular-related blood marker(s) concentration
Time frame: Change from baseline at 14 days
Serum analysis of insulin
Time frame: Change from baseline at 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2016.
- Individual participant dataSharing planned: No
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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 P Spencer, PhD principal investigator
Univerisity of Reading
Questions about this trial
What is this clinical trial studying?
A study testing High-flavanol milk choocolate and Low-flavanol milk chocolate in people with Healthy, run by University of Reading.
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 5 inclusion and 9 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 3 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
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?
Flow-mediated Dilation (FMD) (time frame: Change from baseline at 14 days). 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 3 Jun 2016.