Neural DegenerationNCT01344551
Effects of Cocoa Flavanols on Human Cognitive Function
A study testing Cocoa Drink in people with Neural Degeneration, run by University of Reading at 1 site in United Kingdom.
Trial summary
To determine the acute and chronic effects of cocoa derived flavonoids on cognitive function in healthy older adults. Read more about this study
- Who is it for?
- Ages 60 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Neural Degeneration
- What is being tested?
- Cocoa Drink
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2009to Jan 2013
- 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 60 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 62 - 75 years
- A signed consent form
Who cannot join
- Blood pressure > 160/90 mmHg
- Haemoglobin (anaemia marker) < 125 g/l
- Gamma GT (liver enzymes) > 80 IU/l
- Had suffered a myocardial infarction or stroke in the previous 12 months
- Suffers from any gastrointestinal/stomach disorder
- Suffers from any blood-clotting disorder
Show all 14Show fewer
- On medication for hypertension
- Suffers from any metabolic disorders (e.g. diabetes or any other endocrine or liver diseases)
- Depression or major mental illness
- Any dietary restrictions or on a weight reducing diet
- Drinking more than 21 units per week
- On any medication affecting blood clotting
- Smoking
- Vegans
Trial locations and contacts
1 site in 1 country.
About this study
To determine the acute and chronic effects of cocoa derived flavonoids on cognitive function in healthy older adults.
Read the detailed description
This is a randomised controlled double blind cross over study investigating the acute effects of high flavanol (495mg) compared to low flavanol (23mg)cocoa drink on cognitive function in a healthy older adult population (n=60). The primary outcome measure of this study is to determine the effects of the flavanol intervention on cognitive measures of executive function and attention and the secondary measures of blood pressure and to determine whether any observed effects are paralleled by plasma flavanol levels.
- Conditions
- Neural Degeneration
- Being tested
- Cocoa Drink
- Medical subject headings
- Nerve Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cocoa DrinkDietary supplement
High Flavanol (495mg) Low Flavanol (23mg) Matched for macro and micro nutrients
| Study group | Role | What they receive |
|---|---|---|
| High Flavanol | Active comparator | High Flavanol cocoa drink containing 495mg cocoa Receives: Dietary Supplement: Cocoa Drink |
| Low Flavanol | Placebo comparator | Low Flavanol cocoa drink (23mg) Receives: Dietary Supplement: Cocoa Drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Executive function - attention
Measured: change from baseline to 2 hours
Secondary outcomes (2)
Blood pressure
Measured: change from baseline to 2 hours
Plasma flavanols
Measured: change from baseline to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2011 (estimated)
- Study startFeb 2009
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neural DegenerationStudies 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 63 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, Principal investigator, University of ReadingLaurie Butler, PhD, Principal investigator, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01344551
- Sponsor's protocol ID
- UReading-2011-02
- Status last verified
- Feb 2013
- First submitted
- 27 Apr 2011
- Last updated
- 21 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cocoa Flavanols on Human Cognitive Function
- ClinicalTrials.gov ID
- NCT01344551
- Acronym / sponsor ID
- UReading-2011-02
- Conditions
- Neural Degeneration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 29 Apr 2011 (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.
To determine the acute and chronic effects of cocoa derived flavonoids on cognitive function in healthy older adults.
Detailed description
This is a randomised controlled double blind cross over study investigating the acute effects of high flavanol (495mg) compared to low flavanol (23mg)cocoa drink on cognitive function in a healthy older adult population (n=60). The primary outcome measure of this study is to determine the effects of the flavanol intervention on cognitive measures of executive function and attention and the secondary measures of blood pressure and to determine whether any observed effects are paralleled by plasma flavanol levels.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Flavanol | Active comparator | Dietary Supplement: Cocoa DrinkHigh Flavanol cocoa drink containing 495mg cocoa |
| Low Flavanol | Placebo comparator | Dietary Supplement: Cocoa DrinkLow Flavanol cocoa drink (23mg) |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged 62 - 75 years
- A signed consent form
Key exclusion criteria (14 listed)
- Blood pressure > 160/90 mmHg
- Haemoglobin (anaemia marker) < 125 g/l
- Gamma GT (liver enzymes) > 80 IU/l
- Had suffered a myocardial infarction or stroke in the previous 12 months
- Suffers from any gastrointestinal/stomach disorder
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 |
|---|---|---|
| Cocoa DrinkHigh Flavanol (495mg) Low Flavanol (23mg) Matched for macro and micro nutrients | Dietary supplement | High Flavanol, Low Flavanol |
Primary outcome
Executive function - attention
Time frame: change from baseline to 2 hours
2 secondary outcomes
Blood pressure
Time frame: change from baseline to 2 hours
Plasma flavanols
Time frame: change from baseline to 2 hours
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 21 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 principal investigator
University of Reading
Laurie Butler, PhD principal investigator
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 study testing Cocoa Drink in people with Neural Degeneration, 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 2 inclusion and 14 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 21 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. 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?
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?
Executive function - attention (time frame: change from baseline to 2 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 21 Feb 2013.