Healthy ElderlyNeurophenolNCT02063646
Effect of a Polyphenol-rich Food Supplement on Cognitive Function in Healthy Aging Adults
A study testing Polyphenol-rich extract in people with Healthy Elderly, run by Neurophenols Consortium at 2 sites in 2 countries.
Trial summary
Several preliminary studies have shown that diet can have beneficial effects on cognitive decline. Among food shown to have such effects are some polyphenols from selected botanicals. Read more about this study
- Who is it for?
- Ages 60 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Elderly
- What is being tested?
- Polyphenol-rich extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 204 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Feb 2014to Mar 2015
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Independent subjects, living at home;
- Body Mass Index (BMI) 20-30 kg/m2 (limits included);
- 26 < MMSE score ≤ 29
- Logical memory subtest of the Wechsler Memory Scale (16-69 years battery) sub-scores complying with the following:
- Immediate recall score < 29;
- Delayed recall score < 16;
Who cannot join
- Evidence of actual major depressive disorder according to the module A of the Mini International Neuropsychiatric Interview (MINI);
- Subject consuming food supplements likely to have an effect on memory;
- High physical activity practice;
- Restrictive or unbalanced diet (hypocaloric, vegetarian, vegan, …) self-declared at V0;
- Diabetes;
- Cardiovascular disease diagnosed within less than 2 years, with the following exceptions: subjects with controlled (medicated) high blood pressure and/ or controlled (medicated) can be included;
Show all 17Show fewer
- Personal history of Cerebrovascular Accident (CVA);
- Unbalanced thyroid disease;
- Anti-depressant treatment stopped since less than 3 months or still ongoing;
- Personal history of schizophrenia or other psychiatric disorders;
- Ongoing neuroleptic treatment;
- Uncorrected visual or auditory dysfunction (according to the volunteer's self-declaration);
- History of moderate to severe traumatic brain injury and / or intracranial surgery;
- Life threatening pathology (such as cancer) in remission for less than 1 year or still ongoing;
- General anesthesia in the last 6 months or planned in the next 6 months;
- Documented food allergy(ies), namely to one of the components of the study product;
- Psychological or linguistic incapability to sign the informed consent.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Canada1 site
INAF (Institute of nutrition and functionnal foods)
Québec, Quebec, G1V 0A6
About this study
Official title: Effect of a Polyphenol-rich Food Supplement on Cognitive Function in Healthy Aging Adults: Randomized, Placebo-controlled, Double-blind Clinical Trial
Several preliminary studies have shown that diet can have beneficial effects on cognitive decline. Among food shown to have such effects are some polyphenols from selected botanicals.
Preclinical studies have concluded that polyphenols play a role in moderation of oxidative stress and inflammation, increased neuronal signaling, and improved metabolic function among other effects. Noteworthy, a positive and statistically significant association between the midlife level of polyphenol intake and cognitive function assessed 13 years later was found in a cohort of 2574 adults.
Read more
Several mechanisms may be involved in these positive effects of food polyphenols on cognitive function in older adults: experimental studies suggest that polyphenols display neuroprotective effects, enhancement of the neuronal function, stimulation of brain flow and inducing neurogenesis, and might prevent age-related damage to the central nervous system through their antioxidant and anti-inflammatory activities.
Based on these promising results, a food supplement from botanicals offering complementary polyphenol profile was developed. This food supplement is aimed to aid at maintenance of cognitive function in older adults.
Read the detailed description
This project aims to investigate the effects of 6 months supplementation with a polyphenol-rich supplement vs. placebo to consume daily on human cognitive function. Polyphenol-rich supplement and placebo will be provided as capsules matched for appearance.
The study will be conducted as a randomized, double-blind, parallel-groups (2 arms) placebo-controlled, multicentre interventional design. Two groups, each of 102 volunteers, are studied. One group of volunteers will consume the polyphenol-rich product while the other one will consume the placebo product.
Each volunteer will be seen for 3 visits at the investigational site, will have 2 follow-up calls and mid-term dietary survey. Baseline and follow-up visit will include cognitive assessment with the CANTAB battery. CANTAB tests will cover several aspects of memory: visio-spatial learning and episodic memory, verbal recognition memory and visio-spatial working memory. Moreover, psychological and mood components will be evaluated (mnesic complaint, depression, fatigue). Physical activity and food habits will also be recorded. Finally, biological parameters will be assessed (lipid profile, glycemia, insulinemia, CRPus, thyroid stimulating hormone, transthyretin, plasma level of phenolic compounds).
- Conditions
- Healthy Elderly
- Being tested
- Polyphenol-rich extract, Placebo
- Keywords
- polyphenols, memory, elderly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyphenol-rich extractDietary supplement
Two groups, each of 102 volunteers, are studied. For 24 weeks, one group of volunteers will consume the active product (polyphenol-rich extract) while the other one will consume the placebo product.
PlaceboDietary supplement
The placebo is a capsule with same appearance and organoleptic properties as the active product, containing no active component.
Two groups, each of 102 volunteers, are studied. For 24 weeks, one group of volunteers will consume the active product (polyphenol-rich extract) while the other one will consume the placebo product.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | The placebo is a capsule with same appearance and organoleptic properties as the active product, containing no active component.
Dose: 2 capsules per day, one capsule at least 1 hour after breakfast and one capsule at least one hour after dinner, with a glass of water. Receives: Dietary Supplement: Placebo |
| Polyphenol-rich extract | Experimental | The test product is a food supplement named Neurophenol. It is presented as a hard-shell capsule containing polyphenol-rich extracts.
Dose: 2 capsules per day, one capsule at least 1 hour after breakfast and one capsule at least one hour after dinner, with a glass of water. Receives: Dietary Supplement: Polyphenol-rich extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
CANTAB - Paired Associate Learning test (PAL)
Measured: 24 weeks
Secondary outcomes (8)
CANTAB - Verbal Recognition Memory (VRM)
Measured: 24 weeks
CANTAB - Spatial Span test (SSP)
Measured: 24 weeks
CANTAB - Reverse Spatial Span test (Reverse SSP)
Measured: 24 weeks
Wechsler Memory Scale - Logical memory subtest
Measured: 24 weeks
McNair scale
Measured: 24 weeks
Geriatric Depression Scale
Measured: 24 weeks
Mini-Mental State Examination
Measured: 24 weeks
Multidimensional Fatigue Inventory (MFI-20)
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Healthy ElderlyStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neurophenols Consortium
- Sponsor type
- University, hospital or other
- Collaborators
- Activ'inside, Atrium Innovations, Fruit d'Or, Laboratoire NutriNeuro Université de Bordeaux/INRA, NutraCanada, Laval University
- Responsible party
- Sponsor
- Investigators
- Carol Hudon, Ph.D., Principal investigator, Laval UniversityVéronique Pallet, Ph.D., Principal investigator, Laboratoire NutriNeuro Université de Bordeaux/INRACatherine Bégin, Ph.D., Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02063646
- Sponsor's protocol ID
- INAF-2012-242
- Acronym
- Neurophenol
- Status last verified
- Oct 2014
- First submitted
- 12 Feb 2014
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Krikorian R, Boespflug EL, Fleck DE, Stein AL, Wightman JD, Shidler MD, Sadat-Hossieny S. Concord grape juice supplementation and neurocognitive function in human aging. J Agric Food Chem. 2012 Jun 13;60(23):5736-42. doi: 10.1021/jf300277g. Epub 2012 Apr 9.
PubMed 22468945Kesse-Guyot E, Fezeu L, Andreeva VA, Touvier M, Scalbert A, Hercberg S, Galan P. Total and specific polyphenol intakes in midlife are associated with cognitive function measured 13 years later. J Nutr. 2012 Jan;142(1):76-83. doi: 10.3945/jn.111.144428. Epub 2011 Nov 16.
PubMed 22090468Rossi L, Mazzitelli S, Arciello M, Capo CR, Rotilio G. Benefits from dietary polyphenols for brain aging and Alzheimer's disease. Neurochem Res. 2008 Dec;33(12):2390-400. doi: 10.1007/s11064-008-9696-7. Epub 2008 Apr 16.
PubMed 18415677Spencer JP, Vauzour D, Rendeiro C. Flavonoids and cognition: the molecular mechanisms underlying their behavioural effects. Arch Biochem Biophys. 2009 Dec;492(1-2):1-9. doi: 10.1016/j.abb.2009.10.003. Epub 2009 Oct 12.
PubMed 19822127Vauzour D, Vafeiadou K, Rodriguez-Mateos A, Rendeiro C, Spencer JP. The neuroprotective potential of flavonoids: a multiplicity of effects. Genes Nutr. 2008 Dec;3(3-4):115-26. doi: 10.1007/s12263-008-0091-4.
PubMed 18937002
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Polyphenol-rich Food Supplement on Cognitive Function in Healthy Aging Adults: Randomized, Placebo-controlled, Double-blind Clinical Trial
- ClinicalTrials.gov ID
- NCT02063646
- Acronym / sponsor ID
- Neurophenol / INAF-2012-242
- Conditions
- Healthy Elderly
- Keywords
- polyphenols, memory, elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Neurophenols ConsortiumUniversity, hospital or other
- Collaborators
- Activ'inside, Atrium Innovations, Fruit d'Or, Laboratoire NutriNeuro Université de Bordeaux/INRA, NutraCanada, Laval University
- Study start
- Feb 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 14 Feb 2014 (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.
Several preliminary studies have shown that diet can have beneficial effects on cognitive decline. Among food shown to have such effects are some polyphenols from selected botanicals.
Preclinical studies have concluded that polyphenols play a role in moderation of oxidative stress and inflammation, increased neuronal signaling, and improved metabolic function among other effects. Noteworthy, a positive and statistically significant association between the midlife level of polyphenol intake and cognitive function assessed 13 years later was found in a cohort of 2574 adults.
Several mechanisms may be involved in these positive effects of food polyphenols on cognitive function in older adults: experimental studies suggest that polyphenols display neuroprotective effects, enhancement of the neuronal function, stimulation of brain flow and inducing neurogenesis, and might prevent age-related damage to the central nervous system through their antioxidant and anti-inflammatory activities.
Based on these promising results, a food supplement from botanicals offering complementary polyphenol profile was developed. This food supplement is aimed to aid at maintenance of cognitive function in older adults.
Detailed description
This project aims to investigate the effects of 6 months supplementation with a polyphenol-rich supplement vs. placebo to consume daily on human cognitive function. Polyphenol-rich supplement and placebo will be provided as capsules matched for appearance.
The study will be conducted as a randomized, double-blind, parallel-groups (2 arms) placebo-controlled, multicentre interventional design. Two groups, each of 102 volunteers, are studied. One group of volunteers will consume the polyphenol-rich product while the other one will consume the placebo product.
Each volunteer will be seen for 3 visits at the investigational site, will have 2 follow-up calls and mid-term dietary survey. Baseline and follow-up visit will include cognitive assessment with the CANTAB battery. CANTAB tests will cover several aspects of memory: visio-spatial learning and episodic memory, verbal recognition memory and visio-spatial working memory. Moreover, psychological and mood components will be evaluated (mnesic complaint, depression, fatigue). Physical activity and food habits will also be recorded. Finally, biological parameters will be assessed (lipid profile, glycemia, insulinemia, CRPus, thyroid stimulating hormone, transthyretin, plasma level of phenolic compounds).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboThe placebo is a capsule with same appearance and organoleptic properties as the active product, containing no active component. Dose: 2 capsules per day, one capsule at least 1 hour after breakfast and one capsule at least one hour after dinner, with a glass of water. |
| Polyphenol-rich extract | Experimental | Dietary Supplement: Polyphenol-rich extractThe test product is a food supplement named Neurophenol. It is presented as a hard-shell capsule containing polyphenol-rich extracts. Dose: 2 capsules per day, one capsule at least 1 hour after breakfast and one capsule at least one hour after dinner, with a glass of water. |
Who may qualify
- Ages
- 60 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Independent subjects, living at home;
- Body Mass Index (BMI) 20-30 kg/m2 (limits included);
- 26 < MMSE score ≤ 29
- Logical memory subtest of the Wechsler Memory Scale (16-69 years battery) sub-scores complying with the following:
Key exclusion criteria (17 listed)
- Evidence of actual major depressive disorder according to the module A of the Mini International Neuropsychiatric Interview (MINI);
- Subject consuming food supplements likely to have an effect on memory;
- High physical activity practice;
- Restrictive or unbalanced diet (hypocaloric, vegetarian, vegan, …) self-declared at V0;
- Diabetes;
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 |
|---|---|---|
| Polyphenol-rich extractTwo groups, each of 102 volunteers, are studied. For 24 weeks, one group of volunteers will consume the active product (polyphenol-rich extract) while the other one will consume the placebo product. | Dietary supplement | Polyphenol-rich extract |
| PlaceboThe placebo is a capsule with same appearance and organoleptic properties as the active product, containing no active component. Two groups, each of 102 volunteers, are studied. For 24 weeks, one group of volunteers will consume the active product (polyphenol-rich extract) while the other one will consume the placebo product. | Dietary supplement | Placebo |
Primary outcome
CANTAB - Paired Associate Learning test (PAL)
Time frame: 24 weeks
8 secondary outcomes
CANTAB - Verbal Recognition Memory (VRM)
Time frame: 24 weeks
CANTAB - Spatial Span test (SSP)
Time frame: 24 weeks
CANTAB - Reverse Spatial Span test (Reverse SSP)
Time frame: 24 weeks
Wechsler Memory Scale - Logical memory subtest
Time frame: 24 weeks
McNair scale
Time frame: 24 weeks
Geriatric Depression Scale
Time frame: 24 weeks
Mini-Mental State Examination
Time frame: 24 weeks
Multidimensional Fatigue Inventory (MFI-20)
Time frame: 24 weeks
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 27 May 2015.
- Background: PubMed 22468945Krikorian R, Boespflug EL, Fleck DE, Stein AL, Wightman JD, Shidler MD, Sadat-Hossieny S. Concord grape juice supplementation and neurocognitive function in human aging. J Agric Food Chem. 2012 Jun 13;60(23):5736-42. doi: 10.1021/jf300277g. Epub 2012 Apr 9.
- Background: PubMed 22090468Kesse-Guyot E, Fezeu L, Andreeva VA, Touvier M, Scalbert A, Hercberg S, Galan P. Total and specific polyphenol intakes in midlife are associated with cognitive function measured 13 years later. J Nutr. 2012 Jan;142(1):76-83. doi: 10.3945/jn.111.144428. Epub 2011 Nov 16.
- Background: PubMed 18415677Rossi L, Mazzitelli S, Arciello M, Capo CR, Rotilio G. Benefits from dietary polyphenols for brain aging and Alzheimer's disease. Neurochem Res. 2008 Dec;33(12):2390-400. doi: 10.1007/s11064-008-9696-7. Epub 2008 Apr 16.
- Background: PubMed 19822127Spencer JP, Vauzour D, Rendeiro C. Flavonoids and cognition: the molecular mechanisms underlying their behavioural effects. Arch Biochem Biophys. 2009 Dec;492(1-2):1-9. doi: 10.1016/j.abb.2009.10.003. Epub 2009 Oct 12.
- Background: PubMed 18937002Vauzour D, Vafeiadou K, Rodriguez-Mateos A, Rendeiro C, Spencer JP. The neuroprotective potential of flavonoids: a multiplicity of effects. Genes Nutr. 2008 Dec;3(3-4):115-26. doi: 10.1007/s12263-008-0091-4.
- Click this link for more information about this studyLink provided by the sponsor.
Related trials for Healthy Elderly
Not yet recruiting
Effects of Cannabidiol on Memory and Attention in Adults Aged 60-70: A Pilot Study
Healthy Aging, Cognition
Recruiting
Intervention Program for Psychological Well-Being in Institutionalized Older Adults Through Virtual Reality
Healthy Volunteers, Aging, Healthy
Active, not recruiting
An Effectiveness Evaluation for Pathway to Healthy Aging (Path-HA) Care on Health Status of Older Adults
Ageing Well
Not yet recruiting
Effectiveness of a Smartphone Chatbot to Improve Exercise Adherence in Older Adults
Exercise Adherence, Healthy Aging
Not yet recruitingPhase 1
A Study to Learn How Different Amounts of the Study Medicine Called PF-08161842 Are Tolerated and Act in the Body in Healthy and Older Adults
Alzheimer Disease
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.
Carol Hudon, Ph.D. principal investigator
Laval University
Véronique Pallet, Ph.D. principal investigator
Laboratoire NutriNeuro Université de Bordeaux/INRA
Catherine Bégin, Ph.D. principal investigator
Laval University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polyphenol-rich extract in people with Healthy Elderly, run by Neurophenols Consortium at 2 sites in 2 countries.
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 6 inclusion and 17 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 27 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada, France. 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?
CANTAB - Paired Associate Learning test (PAL) (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02063646, which also lists 5 linked publications.
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 27 May 2015.