Healthy AgingPOLYAGENCT04348162
Food Anthocyanins and Flavanols as a Strategy for a Healthy Ageing: Cardiovascular Health and Cognitive Performance
A study testing Cocoa flavanols and berries anthocyanins in people with Healthy Aging, run by National Research Council, Spain at 1 site in Spain.
Trial summary
The study examines the effect of cocoa flavanols, red-berries anthocyanins or a combination of both on markers of cardiovascular health and cognition. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging
- What is being tested?
- Cocoa flavanols and berries anthocyanins
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSpain
- Study dates
- 15 Sep 2017to 15 May 2021
- 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 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 50-85
- BMI 20-32 Kg/m2
Who cannot join
- Mini-mental state examination (MMSE) < 28
- Systolic blood pressure (SBP) >139 mmHg
- Diastolic blood pressure (DBP) > 89 mmHg
- Total cholesterol > 6.5 mmol/L
Trial locations and contacts
1 site in 1 country.
Spain1 site
Institute of Food Science, Technology and Nutrition (ICTAN), Spanish National Research Council (CISC)
Madrid, 28040
About this study
The study examines the effect of cocoa flavanols, red-berries anthocyanins or a combination of both on markers of cardiovascular health and cognition.
Read the detailed description
The study examines the effect of cocoa flavanols, red-berries anthocyanins or a combination of both on markers of cardiovascular health and cognition.
Healthy volunteers are recruited to participate in a parallel study (n 30 per group) for 10 to 12 weeks. Markers of cardiovascular health (FMD, markers of inflammation and fatty acid metabolism) and cognition (neuropsychological tests and plasma neurotrophins) are being measured before and after intervention.
- Conditions
- Healthy Aging
- Being tested
- Cocoa flavanols and berries anthocyanins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cocoa flavanols and berries anthocyaninsOther
Effect of cocoa flavanols and berries anthocyanins on cardiovascular and cognitive health
| Study group | Role | What they receive |
|---|---|---|
| Cocoa Flavanols | Active comparator | Cocoa is taken every day for 10-12 weeks. Receives: Other: Cocoa flavanols and berries anthocyanins |
| Berries anthocyanins | Active comparator | Red-berries are taken every day for 10-12 weeks. Receives: Other: Cocoa flavanols and berries anthocyanins |
| Cocoa flavanols plus berries anthocyanins | Active comparator | Cooa and red-berries are taken every day for 10-12 weeks. Receives: Other: Cocoa flavanols and berries anthocyanins |
| Control | No intervention | Normal diet for 10-12 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of flow-mediated vasodilatation (FMD) of the brachial artery
The FMD of the brachial artery will be measured using an ultrasound collected at baseline and continuously for 60 seconds post-arm occlusion for 5 minutes. FMD will be expressed as percentage of variation between pre-and postischemic diameters
Measured: Over 6 minutes on day 0 and after10 weeks
Secondary outcomes (2)
Change from baseline STROOP score after 10 weeks intervention
STROOP tests attention and executive function. This test aims to evaluate the inhibition of an automated process such as reading by asking participants to name the color of color names written in a different color ink.
For each participant SROOP results at inclusion will be compared with results after 10 weeks intervention
Measured: at inclusion and 10 weeks after intervention
Change from baseline Tower of London score after 10 weeks intervention
Tower of London test consist of a three color game board that allows executive functioning evaluation by total time, time to first move and optimal moves change from participants inclusion to week 11.
Measured: at inclusion and 10 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start15 Sep 2017
- Primary completion1 Jan 2021
- Study completion15 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AgingStudies 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
- Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Research Council, Spain
- Sponsor type
- Other government
- Collaborators
- Hospital Universitario 12 de Octubre
- Responsible party
- Principal investigator, Spanish National Research Council, National Research Council, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04348162
- Sponsor's protocol ID
- AGL2016-76832-R
- Acronym
- POLYAGE
- Status last verified
- Apr 2020
- First submitted
- 26 Mar 2020
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food Anthocyanins and Flavanols as a Strategy for a Healthy Ageing: Cardiovascular Health and Cognitive Performance
- ClinicalTrials.gov ID
- NCT04348162
- Acronym / sponsor ID
- POLYAGE / AGL2016-76832-R
- Conditions
- Healthy Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- National Research Council, SpainOther government
- Collaborators
- Hospital Universitario 12 de Octubre
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 15 May 2021 (actual)
- First posted
- 16 Apr 2020 (actual)
- 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.
The study examines the effect of cocoa flavanols, red-berries anthocyanins or a combination of both on markers of cardiovascular health and cognition.
Detailed description
The study examines the effect of cocoa flavanols, red-berries anthocyanins or a combination of both on markers of cardiovascular health and cognition.
Healthy volunteers are recruited to participate in a parallel study (n 30 per group) for 10 to 12 weeks. Markers of cardiovascular health (FMD, markers of inflammation and fatty acid metabolism) and cognition (neuropsychological tests and plasma neurotrophins) are being measured before and after intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cocoa Flavanols | Active comparator | Other: Cocoa flavanols and berries anthocyaninsCocoa is taken every day for 10-12 weeks. |
| Berries anthocyanins | Active comparator | Other: Cocoa flavanols and berries anthocyaninsRed-berries are taken every day for 10-12 weeks. |
| Cocoa flavanols plus berries anthocyanins | Active comparator | Other: Cocoa flavanols and berries anthocyaninsCooa and red-berries are taken every day for 10-12 weeks. |
| Control | No intervention | –Normal diet for 10-12 weeks |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 50-85
- BMI 20-32 Kg/m2
Key exclusion criteria (4 listed)
- Mini-mental state examination (MMSE) < 28
- Systolic blood pressure (SBP) >139 mmHg
- Diastolic blood pressure (DBP) > 89 mmHg
- Total cholesterol > 6.5 mmol/L
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 flavanols and berries anthocyaninsEffect of cocoa flavanols and berries anthocyanins on cardiovascular and cognitive health | Other | Berries anthocyanins, Cocoa Flavanols, Cocoa flavanols plus berries anthocyanins |
Primary outcome
Change from baseline of flow-mediated vasodilatation (FMD) of the brachial artery
Time frame: Over 6 minutes on day 0 and after10 weeks
The FMD of the brachial artery will be measured using an ultrasound collected at baseline and continuously for 60 seconds post-arm occlusion for 5 minutes. FMD will be expressed as percentage of variation between pre-and postischemic diameters
2 secondary outcomes
Change from baseline STROOP score after 10 weeks intervention
Time frame: at inclusion and 10 weeks after intervention
Change from baseline Tower of London score after 10 weeks intervention
Time frame: at inclusion and 10 weeks after intervention
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 16 Sep 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 flavanols and berries anthocyanins in people with Healthy Aging, run by National Research Council, Spain at 1 site in Spain.
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 4 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 16 Sep 2021. 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 Spain. 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.
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?
Change from baseline of flow-mediated vasodilatation (FMD) of the brachial artery (time frame: Over 6 minutes on day 0 and after10 weeks). 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 16 Sep 2021.