Mental ProcessesCoCo_ChronicNCT03030053
The Effects of Flavonoid Supplementation on Cognition and Neural Mechanisms in Healthy Older Adults
A study testing Cocoa-Flavanol Supplements in people with Mental Processes, run by University of Reading at 1 site in United Kingdom.
Trial summary
A double-blind, randomised, controlled, parallel arm chronic intervention trial with healthy older adults will be conducted to determine the effect of a flavonoid-rich supplement on cognitive function, peripheral arterial health and brain mechanisms. Read more about this study
- Who is it for?
- Ages 60 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Processes
- What is being tested?
- Cocoa-Flavanol Supplements
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2016to Dec 2018
- 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
- Males and females aged 60-75 years
- English as primary language, able to understand the study information sheet, follow instructions in English and give informed consent
- Non-smokers
- Alcohol consumption should be within the current National Health Service (NHS) recommendation - women: ≤21 units per week (max 3 per day), 1 large 250mL glass of wine (Alcohol By Volume 12%) is 3 units; men: ≤ 28 units per week (max 4 per day), 1 pint of strong lager/beer/cider (Alcohol By Volume 5.2%) is 3 units
- BP <150/90 (determined at screening)
- BMI <30 (determined at screening)
Show all 27Show fewer
- Full blood count parameters within the normal range, specifically:
- Haemoglobin to check for anaemia (>12.5 g/dL for males and >11.5 g/dL for females)
- Total white cell count (3.6-11.0 x109/L)
- Differential count:
- Neutrophils (1.8 - 7.5 x109/L)
- Lymphocytes (1.0 - 4.0 x109/L)
- Monocytes (0.2 - 0.8 x109/L)
- Eosinophils (0.1 - 0.4 x109/L)
- Basophils (0.02 - 0.1 x109/L)
- Normal platelet function (platelet count 140-400 x109/L)
- Red cell count (4.50-6.50 x1012/L for males; 3.80-5.80 x1012/L for females)
- Haematocrit (0.40-0.54 L/L for males; 0.37-0.47 L/L for females)
- Mean Cell Volume (80-100 fL)
- Mean Cell Haemoglobin (27-32 pg)
- Reticulocyte Count (0.2-2.0 %)
- The following blood parameters within the normal range:
- Liver function (gamma-glutamyl transpeptidase [GGT] level < 80 IU/L, alanine transaminase [ALT] < 30 U/L, alkaline phosphatase [ALP] < 320 U/L),
- Kidney function (total bilirubin ≤ 22 μmol/L, creatinine ≤ 106 μmol/L, uric acid < 506 μmol/L),
- Fasting blood glucose level (< 7 mmol/L),
- Triglycerides (< 2.2 mmol/L)
- Plasma cholesterol (< 8 mmol/L)
Who cannot join
- General global cognitive impairment (Mini Mental State Examination score < 24)
- Un-corrected vision or hearing problems
- Speech or communication difficulties
- Currently suffering from depression (Brief Symptom Inventory score of ≥ 11)
- Diagnosed with any learning difficulty such as Dyslexia or Dyspraxia
- Sensitive/allergic to the intervention or any of the study foods
Show all 23Show fewer
- Suffering from any form of clinically diagnosed disease, including:
- Major mental illness (current or previous episode with hospitalization)
- Chronic fatigue syndrome
- Liver disease
- Diabetes mellitus
- Heart disease or myocardial infarction
- Taking blood pressure medication, anticoagulants, anti-platelet medication or antidepressants
- On a weight reducing dietary regimen or taking any dietary supplements (including dietary fatty acids), unless willing to temporarily refrain from taking dietary supplements for the duration of the study
- Subjects consuming more than seven portions of fruit and vegetables a day
- Subjects consuming more than five cups of tea a day
- Men taking part in more than 10.5 hours of moderate to vigorous exercise per week and women taking part in more than 7 hours of moderate to vigorous exercise per week (assessed on an individual basis to avoid recruitment of people who exercise too vigorously)
- Taking illegal substances
- MRI part:
- Has a heart pacemaker or metal implants (including any non-removable ferro-magnetic dental items)
- Any body piercing items that cannot be removed
- Is claustrophobic
- Note: Participation in other research trials within the last month will need to be declared and may affect the start date for participation in the current trial.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Hugh Sinclair Unit of Human Nutrition, University of Reading
Reading, Berkshire, RG6 5SG
About this study
Official title: Mechanistic Assessment of the Acute and Chronic Cognitive Effects of Flavanol/Anthocyanin Intervention in Humans - Chronic Trial
A double-blind, randomised, controlled, parallel arm chronic intervention trial with healthy older adults will be conducted to determine the effect of a flavonoid-rich supplement on cognitive function, peripheral arterial health and brain mechanisms. It is predicted that chronic flavonoid supplementation will result in cognitive benefits and that these may be due to beneficial effects of flavonoids on vascular and brain function.
Read the detailed description
There has recently been an increasing interest in the potential of flavonoids, plant derived compounds found in foods such as fruit and vegetables, to improve cognitive function. Research suggests that flavonoids improve memory and learning, possibly as a result of their anti-inflammatory and neuroprotective effects, for example by increasing cerebral blood flow (CBF), protecting vulnerable neurons, or by stimulating neuronal function and growth. The proposed research will involve a parallel design chronic dietary supplementation trial using a flavonoid-supplement and a matched control containing no flavonoids, to investigate long-term changes in cognitive performance. To understand the neural mechanisms behind potential changes in cognitive performance, resting cerebral blood flow (CBF), blood-oxygen level dependent (BOLD) response during two sensitive tests of cognitive performance, and structural brain changes will be measured in a group of healthy elderly adults (N=70, age range 60-75 years) using magnetic resonance imaging (MRI). Additionally, peripheral vascular health will be measured using flow mediated dilatation (FMD), and bioavailability of flavonoid monomers and metabolites will be determined through analysis of plasma and urine samples. Biomarkers in the blood associated with vascular health and neural functioning as well as markers of interest in relation to the possible mechanisms of action of flavonoids will also be measured. All endpoints will be acquired before and after a 24-week chronic supplementation of either a high flavonoid supplementation or a control product, consumed in addition to participants' normal diet. Measures will also be taken following a 12-week post-intervention washout period in order to investigate whether any beneficial effects are sustained following cessation of supplementation.
- Conditions
- Mental Processes
- Being tested
- Cocoa-Flavanol Supplements, Control Supplements
- Keywords
- Flavanols, Flavonoids, Polyphenols, Cognition, Aging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cocoa-Flavanol SupplementsDietary supplement
3 capsules each containing 300mg cocoa flavanols (total daily dose of 900mg cocoa-flavanols).
Control SupplementsDietary supplement
3 capsules each containing 0mg cocoa-flavanols
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Cocoa-Flavanol Supplements: 3 capsules per day each containing 300mg (total dose of 900mg daily) for 24 weeks Receives: Dietary Supplement: Cocoa-Flavanol Supplements |
| Control | Placebo comparator | Control Supplements: 0mg cocoa-flavanols per day for 24 weeks Receives: Dietary Supplement: Control Supplements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cognitive Performance (0-24 weeks)
Composite measure of global cognitive function (scores from different cognitive tasks will be standardised to allow an overall score of global cognitive function to be calculated)
Measured: Change from baseline (pre intervention) to week 24 (post intervention)
Change in Cognitive Performance (0-36 weeks)
Composite measure of global cognitive function (scores from different cognitive tasks will be standardised to allow an overall score of global cognitive function to be calculated)
Measured: Change from baseline (pre intervention) to week 36 (follow-up)
Secondary outcomes (18)
Change in Flow Mediated Dilatation (0-24 weeks)
Technique to measure the flexibility of the endothelium in larger peripheral blood vessels
Measured: Change from baseline (pre intervention) to week 24 (post intervention)
Change in Flow Mediated Dilatation (0-36 weeks)
Technique to measure the flexibility of the endothelium in larger peripheral blood vessels
Measured: Change from baseline (pre intervention) to week 36 (follow-up)
Change in cerebral blood flow (0-24 weeks)
Use of arterial spin labelling to determine cerebral blood flow at rest
Measured: Change from baseline (pre intervention) to week 24 (post intervention)
Change in cerebral blood flow (0-36 weeks)
Use of arterial spin labelling to determine cerebral blood flow at rest
Measured: Change from baseline (pre intervention) to week 36 (post intervention)
Change in brain activity (0-24 weeks)
Use of functional MRI to determine BOLD response (indicative of brain activation) during cognitive activity
Measured: Change from baseline (pre intervention) to week 24 (post intervention)
Change in brain activity (0-36 weeks)
Use of functional MRI to determine BOLD response (indicative of brain activation) during cognitive activity
Measured: Change from baseline (pre intervention) to week 36 (post intervention)
Change in brain structure (0-24 weeks)
Use of high resolution images to determine changes to brain structure such as grey and white matter
Measured: Change from baseline (pre intervention) to week 24 (follow-up)
Change in brain structure (0-36 weeks)
Use of high resolution images to determine changes to brain structure such as white and grey matter
Measured: Change from baseline (pre intervention) to week 36 (follow-up)
Change in flavanol monomer levels
Concentrations of epicatechin and catechin in plasma and urine samples
Measured: Change from baseline (pre intervention) to week 24 (post intervention)
Change in procyanidin levels
Concentrations of procyanidin dimers through to decamers in plasma and urine samples
Measured: Change from baseline (pre intervention) to week 24 (post intervention)
Change in levels of flavanol monomer metabolites/derivatives
Concentrations of epicatechin and catechin metabolites/derivatives in plasma and urine samples
Measured: Change from baseline (pre intervention) to week 24 (post intervention)
Change in levels of procyanidin metabolites/derivatives
Concentrations of procyanidin metabolites/derivatives in plasma and urine samples
Measured: Change from baseline (pre intervention) to week 24 (post intervention)
Change in levels of nitroso compounds
Concentrations of nitric oxide, nitrate and nitrite levels in plasma/serum \&/ urine
Measured: Change from baseline (pre intervention) to week 24 (post intervention)
Change in levels of markers of inflammation
Concentrations of pro and anti-inflammatory cytokines and C-reactive protein (CRP) levels in plasma/serum
Measured: Change from baseline (pre intervention) to week 24 (post intervention)
Change in levels of markers of neuronal function
Concentrations of brain-derived neurotrophic factor (BDNF) and lactate in plasma/serum
Measured: Change from baseline (pre intervention) to week 24 (post intervention)
Change in levels of a marker of stress/anxiety
Concentrations of cortisol in plasma/serum
Measured: Change from baseline (pre intervention) to week 24 (post intervention)
Change in levels of a marker of oxidative stress
Concentrations of uric acid in plasma/serum
Measured: Change from baseline (pre intervention) to week 24 (post intervention)
Change in levels of markers of vascular function/cardiovascular disease (CVD) risk
Concentrations of glucose, insulin, cholesterol (total, high density lipoprotein [HDL], low density lipoprotein [LDL]), non-esterified fatty acids [NEFA], triglycerides [TAG] in plasma/serum
Measured: Change from baseline (pre intervention) to week 24 (post intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2017 (estimated)
- Study startFeb 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental ProcessesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Collaborators
- Mars, Inc., Biotechnology and Biological Sciences Research Council
- Responsible party
- Principal investigator, Jeremy Paul Edward Spencer, University of Reading
- Investigators
- Jeremy PE Spencer, PhD, Principal investigator, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03030053
- Sponsor's protocol ID
- UREC1548_CoCo_ChronicTrial
- Acronym
- CoCo_Chronic
- Status last verified
- May 2018
- First submitted
- 7 May 2016
- Last updated
- 24 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: To achieve the aim of data sharing with the wider community data will be submitted for inclusion in the Biotechnology and Biological Sciences Research Council (BBSRC)-funded Code Analysis, Repository \& Modelling for E-Neuroscience (CARMEN) depository for neurophysiological datasets (http://www.carmen.org.uk). Data will also be accessible by making a direct request to the PI, and will be transferred to the recipient. Publications will be in open access journals where possible. If not possible, due to the need to reach the widest possible audience, pre-publication manuscripts arising from the project will be deposited in the free and publicly searchable University of Reading research database (CentAUR: http://centaur.reading.ac.uk). All data will be made available in an anonymised format upon request following publication of main findings. It is envisaged that the entire datasets will be available 6 months following the end of the project and maintained for a period of at least 10 years.
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanistic Assessment of the Acute and Chronic Cognitive Effects of Flavanol/Anthocyanin Intervention in Humans - Chronic Trial
- ClinicalTrials.gov ID
- NCT03030053
- Acronym / sponsor ID
- CoCo_Chronic / UREC1548_CoCo_ChronicTrial
- Conditions
- Mental Processes
- Keywords
- Flavanols, Flavonoids, Polyphenols, Cognition, Aging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Collaborators
- Mars, Inc., Biotechnology and Biological Sciences Research Council
- Study start
- Feb 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 24 Jan 2017 (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 double-blind, randomised, controlled, parallel arm chronic intervention trial with healthy older adults will be conducted to determine the effect of a flavonoid-rich supplement on cognitive function, peripheral arterial health and brain mechanisms. It is predicted that chronic flavonoid supplementation will result in cognitive benefits and that these may be due to beneficial effects of flavonoids on vascular and brain function.
Detailed description
There has recently been an increasing interest in the potential of flavonoids, plant derived compounds found in foods such as fruit and vegetables, to improve cognitive function. Research suggests that flavonoids improve memory and learning, possibly as a result of their anti-inflammatory and neuroprotective effects, for example by increasing cerebral blood flow (CBF), protecting vulnerable neurons, or by stimulating neuronal function and growth. The proposed research will involve a parallel design chronic dietary supplementation trial using a flavonoid-supplement and a matched control containing no flavonoids, to investigate long-term changes in cognitive performance. To understand the neural mechanisms behind potential changes in cognitive performance, resting cerebral blood flow (CBF), blood-oxygen level dependent (BOLD) response during two sensitive tests of cognitive performance, and structural brain changes will be measured in a group of healthy elderly adults (N=70, age range 60-75 years) using magnetic resonance imaging (MRI). Additionally, peripheral vascular health will be measured using flow mediated dilatation (FMD), and bioavailability of flavonoid monomers and metabolites will be determined through analysis of plasma and urine samples. Biomarkers in the blood associated with vascular health and neural functioning as well as markers of interest in relation to the possible mechanisms of action of flavonoids will also be measured. All endpoints will be acquired before and after a 24-week chronic supplementation of either a high flavonoid supplementation or a control product, consumed in addition to participants' normal diet. Measures will also be taken following a 12-week post-intervention washout period in order to investigate whether any beneficial effects are sustained following cessation of supplementation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Dietary Supplement: Cocoa-Flavanol SupplementsCocoa-Flavanol Supplements: 3 capsules per day each containing 300mg (total dose of 900mg daily) for 24 weeks |
| Control | Placebo comparator | Dietary Supplement: Control SupplementsControl Supplements: 0mg cocoa-flavanols per day for 24 weeks |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Males and females aged 60-75 years
- English as primary language, able to understand the study information sheet, follow instructions in English and give informed consent
- Non-smokers
- Alcohol consumption should be within the current National Health Service (NHS) recommendation - women: ≤21 units per week (max 3 per day), 1 large 250mL glass of wine (Alcohol By Volume 12%) is 3 units; men: ≤ 28 units per week (max 4 per day), 1 pint of strong lager/beer/cider (Alcohol By Volume 5.2%) is 3 units
- BP <150/90 (determined at screening)
Key exclusion criteria (23 listed)
- General global cognitive impairment (Mini Mental State Examination score < 24)
- Un-corrected vision or hearing problems
- Speech or communication difficulties
- Currently suffering from depression (Brief Symptom Inventory score of ≥ 11)
- Diagnosed with any learning difficulty such as Dyslexia or Dyspraxia
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-Flavanol Supplements3 capsules each containing 300mg cocoa flavanols (total daily dose of 900mg cocoa-flavanols). | Dietary supplement | Active |
| Control Supplements3 capsules each containing 0mg cocoa-flavanols | Dietary supplement | Control |
Primary outcome
Change in Cognitive Performance (0-24 weeks)
Time frame: Change from baseline (pre intervention) to week 24 (post intervention)
Composite measure of global cognitive function (scores from different cognitive tasks will be standardised to allow an overall score of global cognitive function to be calculated)
Change in Cognitive Performance (0-36 weeks)
Time frame: Change from baseline (pre intervention) to week 36 (follow-up)
Composite measure of global cognitive function (scores from different cognitive tasks will be standardised to allow an overall score of global cognitive function to be calculated)
18 secondary outcomes
Change in Flow Mediated Dilatation (0-24 weeks)
Time frame: Change from baseline (pre intervention) to week 24 (post intervention)
Change in Flow Mediated Dilatation (0-36 weeks)
Time frame: Change from baseline (pre intervention) to week 36 (follow-up)
Change in cerebral blood flow (0-24 weeks)
Time frame: Change from baseline (pre intervention) to week 24 (post intervention)
Change in cerebral blood flow (0-36 weeks)
Time frame: Change from baseline (pre intervention) to week 36 (post intervention)
Change in brain activity (0-24 weeks)
Time frame: Change from baseline (pre intervention) to week 24 (post intervention)
Change in brain activity (0-36 weeks)
Time frame: Change from baseline (pre intervention) to week 36 (post intervention)
Change in brain structure (0-24 weeks)
Time frame: Change from baseline (pre intervention) to week 24 (follow-up)
Change in brain structure (0-36 weeks)
Time frame: Change from baseline (pre intervention) to week 36 (follow-up)
Change in flavanol monomer levels
Time frame: Change from baseline (pre intervention) to week 24 (post intervention)
Change in procyanidin levels
Time frame: Change from baseline (pre intervention) to week 24 (post intervention)
Change in levels of flavanol monomer metabolites/derivatives
Time frame: Change from baseline (pre intervention) to week 24 (post intervention)
Change in levels of procyanidin metabolites/derivatives
Time frame: Change from baseline (pre intervention) to week 24 (post intervention)
Change in levels of nitroso compounds
Time frame: Change from baseline (pre intervention) to week 24 (post intervention)
Change in levels of markers of inflammation
Time frame: Change from baseline (pre intervention) to week 24 (post intervention)
Change in levels of markers of neuronal function
Time frame: Change from baseline (pre intervention) to week 24 (post intervention)
Change in levels of a marker of stress/anxiety
Time frame: Change from baseline (pre intervention) to week 24 (post intervention)
Change in levels of a marker of oxidative stress
Time frame: Change from baseline (pre intervention) to week 24 (post intervention)
Change in levels of markers of vascular function/cardiovascular disease (CVD) risk
Time frame: Change from baseline (pre intervention) to week 24 (post intervention)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2018.
- Individual participant dataSharing planned: Yes. To achieve the aim of data sharing with the wider community data will be submitted for inclusion in the Biotechnology and Biological Sciences Research Council (BBSRC)-funded Code Analysis, Repository \& Modelling for E-Neuroscience (CARMEN) depository for neurophysiological datasets (http://www.carmen.org.uk). Data will also be accessible by making a direct request to the PI, and will be transferred to the recipient. Publications will be in open access journals where possible. If not possible, due to the need to reach the widest possible audience, pre-publication manuscripts arising from the project will be deposited in the free and publicly searchable University of Reading research database (CentAUR: http://centaur.reading.ac.uk). All data will be made available in an anonymised format upon request following publication of main findings. It is envisaged that the entire datasets will be available 6 months following the end of the project and maintained for a period of at least 10 years.
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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 PE Spencer, 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-Flavanol Supplements in people with Mental Processes, 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 27 inclusion and 23 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 24 May 2018. 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?
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?
Change in Cognitive Performance (0-24 weeks) (time frame: Change from baseline (pre intervention) to week 24 (post intervention)). 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?
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 24 May 2018.