Memory ImpairmentCCIRF-IINCT01766180
Cerebrovascular and Cognitive Improvement by Resveratrol (resVida) and Fruitflow-II (CCIRF-II)
A study testing Fruitflow-II and resVida in people with Memory Impairment, run by Neurolgy Institute for Brain Health and Fitness at 1 site in United States.
Trial summary
The purpose of this study is to determine whether Fruitflow-II, Resveratrol (resVida), alone or in combination, are effective in the treatment of memory problems in adult patients with memory impairment. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Memory Impairment
- What is being tested?
- Fruitflow-II and resVida
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Feb 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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between the ages of 50 and 80;
- Having a primary care physician;
- Ability to speak, read, and write English;
- Logical Memory subtest (of the Wechsler Memory Scale - IV [WMS-IV]) raw score one standard deviation or greater below the mean of a younger population;
- Be in stable overall health based on medical history and physical examination;
- Sedentary or moderately active (< 2 aerobic session / week);
- Suspend, for at least one month before participating in the study, the use of dietary supplements (fish oil, seed oils, ginkgo biloba, ginseng, resveratrol, fruit powder extracts and DHA; subjects who have high intake of these products are asked to take off these products for 4 weeks and after this washout period they will be recruited in the study). No more than one multivitamins per day is acceptable;
- Wine intake not more than 2 glasses per day
Who cannot join
- Patients reporting severe depression with or without suicidal ideation [Beck Depression Inventory (BDI) > 30 and BDI item #9 >1];
- Patients with a severe language or hearing and/or vision impairment;
- Pregnancy;
- Patients presenting with delirium, dementia, or cognitive impairment (Mini-Mental Status Examination score < 26);
- Current alcohol or substance abuse/dependence;
- Major neurological and psychiatric diseases including Parkinson's disease, Alzheimer's disease, epilepsy, multiple sclerosis, concussion/traumatic brain injury, schizophrenia, bipolar disorder, psychosis, eating disorders;
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- Uncontrolled high blood pressure (> 180/100 mmHg) or a documented record of uncontrolled high blood pressure-related complications such as cerebral vascular disease (CVD), and/or large strokes with disability, uncontrolled diabetes mellitus (medical report of blood HbA1c > 7 during the last three months; in diabetic patients without this record HbA1c will be measured in the first blood testing), or history of major cardiopulmonary disease such as congestive heart failure, pulmonary disorders (COPD [emphysema or chronic bronchitis] and pulmonary embolism);
- Documented evidence of the following findings in the current medical history of subjects:
- 8-1- Low platelet number (< 170 x 10^9/ L); 8-2- Hematocrit below 40% for males or 30% for females; 8-3- Haemoglobin below 120 g/L for males or 110 g/L for females; 8-4- Prothrombin time (PT) values outside normal range of approximately 10-16 s;
- Current hepatic failure, renal failure, bleeding disorders (hemophilia, Von Willebrand disease, esophageal varicoses);
- Subjects who have given 500 ml of blood or more for transfusion purposes in the past month before entry into the study
- Patients who take aspirin more than 325 mg/day
- Current medications for cognition such as acetylcholine esterase inhibitors (e.g., tacrine, donepezil, galantamine, rivastigmin) and memantine;
- Known history of allergies to tomatoes or tomato-based products;
- High habitual intake of tomatoes, grapes, and tomato-based products confirmed by food frequency questionnaire (>5 times per day). Subjects who have high intake of these products are asked to take off these products for 4 weeks and after this washout period they will be reconsidered to participate in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Memosyn Neurology Institute, 1205 York Road, Suite 11
Lutherville, Maryland, 21093
Majid Fotuhi, MD, PhD, 443-275-1687, mfotuhi@jhu.edu
Mehrnoosh Hadadi, MD, MPH, (443) 275-1687, Mehr_Hadadi@yahoo.com
About this study
Official title: Association Between Fruitflow-II Treatment (Alone or in Combination With Resveratrol) and Changes in Cerebral Blood Flow, Fitness and Cognitive Function in Adults With Memory Complaints
The purpose of this study is to determine whether Fruitflow-II, Resveratrol (resVida), alone or in combination, are effective in the treatment of memory problems in adult patients with memory impairment. We also evaluate effects of these medications on blood flow to the brain and fitness, to find whether the possible improvement in memory is associated with the alterations in these parameters.
Read the detailed description
Accumulating evidence suggests that tomato consumption has cardiovascular benefits, primarily through increasing blood flow in vivo; the active ingredient in tomato, or its extract (Fruitflow) have been shown to inhibit glycoprotein IIb/IIIa, similar to aspirin (which has antiplatelet activity and is used for secondary prevention of cardiovascular and cerebrovascular events in patients). Considering the fact that Fruitflow can improve the platelet function and peripheral blood flow, we hypothesized that Fruitflow can also increase the blood flow in the brain and thereby possibly enhance memory and cognitive function in middle-aged or elderly people who have memory complaints. Therefore, the initial goal of our study is to evaluate the effects of Fruitflow on brain blood and cardiovascular function by using Transcranial Doppler ultrasound (to check for changes in cerebral blood flow), cardiovascular fitness testing (to check for changes in VO2-max and stroke volume), and neurocognitive evaluation (to check for changes in memory and executive function).
Many pathways such as inflammation and oxidative stress are involved in the pathophysiology of memory loss with ageing. Recent studies have shown that a natural compound found in the skin of red grapes and also in wine, called "Resveratrol", have beneficial effects for prevention of cognitive decline by reducing inflammation and improving cardiovascular function. Therefore, our next goal is to evaluate whether administration of Resveratrol, by itself or in combination with Fruitflow, can improve brain blood flow, VO2-max, and cognitive performance.
Thus our clinical trial will have the following 4 arms: Fruitflow, Resveratrol, Fruitflow/Resveratrol combination, and placebo for each supplement.
The results of the study will potentially provide evidence that these natural supplements can have significant cardioprotective and neuroprotective properties in middle-aged and elderly adults.
Subjects (between 50 and 80 years old) complaining of memory problem who have MMSE (Mini-Mental State Examination) above 27 will be recruited from patients of Dr. Majid Fotuhi (PI at the Neurology Institute for Brain Health and Fitness). Flyers at the institute and advertisement in Baltimore will provide information about the opportunity to enroll in an observational study for 3 months, along with eligibility criteria. Participants will continue to receive routine and standard care, while data on outcome (i.e., dependent) variables and mediators will be collected over three study visits:
Day 1: at the onset of their participation: Assessment of memory and Cardiovascular Fitness Testing (CFT)
Day 2: Blood Test and Transcranial Doppler (TCD) Ultrasound at time 0 and 3 hours after taking the first dose of the supplements;
Month 3: Assessment of memory, Cardiovascular Fitness Testing, and Transcranial Doppler Ultrasound 3 months after daily treatment with supplements in each group.
- Conditions
- Memory Impairment
- Being tested
- Fruitflow-II, resVida
- Keywords
- Memory, Fruitflow, Resveratrol (resVida), Cerebral blood flow, Cardiopulmonary exercise test, Maximal VO2
- Medical subject headings
- Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fruitflow-IIDrug
150 mg/day for 3 months, orally
resVidaDrug
Also called "resVida" is other name for Resveratrol.
150 mg/day for 3 months, orally
| Study group | Role | What they receive |
|---|---|---|
| Placebo / Placebo | No intervention | In this control group, subjects receives placebo supplement pills without Fruitflow or ResVida ingredients. |
| Fruitflow-II / Placebo | Active comparator | In this group subjects receive Fruitflow-II daily supplied in capsules which contain 150 mg active ingredient. They also receive placebo capsules for resVida. Receives: Drug: Fruitflow-II |
| Placebo / resVida | Active comparator | In this group subjects receive resVida daily supplied in capsules which contain 150 mg active ingredient. They also receive placebo capsules for Fruitflow-II. Receives: Drug: resVida |
| Fruitflow-II / resVida | Active comparator | In this group subjects receive resVida and Fruitflow-II daily supplied in capsules which contain 150 mg active ingredient. Receives: Drug: Fruitflow-II; Drug: resVida |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of improvement in memory after treatment with Fruitflow-II, resVida (Resveratrol), alone or in combination
The following tests will be used for evaluating cognitive function:
- Cambridge Neuropsychological Test Automated Battery (CANTAB). We use 5 tests which are mostly related to memory functioning including following:
- Visual memory tests incuding (A) Paired Associates Learning (PAL) and (B) Pattern Recognition Memory (PRM)
- Executive function, working memory and planning tests including (A) Stockings of Cambridge (SOC) and (B) Spatial Working Memory (SWM)
- Semantic/verbal memory tests including (A) Verbal Recognition Memory (VRM)
- Trail-Making Test (TMT)
- Verbal Fluency Test
Measured: 3 months
Secondary outcomes (2)
Maximal VO2 (VO2 max)
Aerobic fitness (VO2 max) will be assessed by graded maximal exercise testing on a stationary bicycle. Oxygen uptake (VO2) will be measured from expired air samples to be taken at 30-s intervals until a maximal VO2 (VO2 max) is attained or to the point of test termination secondary to symptom limitation and/or volitional exhaustion. VO2 max will be defined as the highest recorded VO2 value when two of three criteria are satisfied: (1) a plateau in VO2 peak between two or more workloads; (2) a respiratory exchange ratio >1.00; and (3) a heart rate equivalent to their age-predicted maximum.
Measured: 3 months
Blood Flow to the Brain
Cerebral blood flow velocity will be measured in the middle cerebral artery (MCA) and basilar artery (BA) using Transcranial Doppler ultrasonography.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionJan 2016 (estimated)
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Memory ImpairmentStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neurolgy Institute for Brain Health and Fitness
- Sponsor type
- University, hospital or other
- Collaborators
- dsm-firmenich Switzerland AG
- Responsible party
- Principal investigator, Majid Fotuhi, MD, PhD, Neurolgy Institute for Brain Health and Fitness
- Investigators
- Majid Fotuhi, MD, PhD, Principal investigator, Memosyn Neurology InstituteMehrnoosh Hadadi, MD, MPH, Study director, Memosyn Neurology Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01766180
- Sponsor's protocol ID
- 2012-1048
- Acronym
- CCIRF-II
- Status last verified
- Apr 2015
- First submitted
- 8 Jan 2013
- Last updated
- 21 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Fruitflow-II Treatment (Alone or in Combination With Resveratrol) and Changes in Cerebral Blood Flow, Fitness and Cognitive Function in Adults With Memory Complaints
- ClinicalTrials.gov ID
- NCT01766180
- Acronym / sponsor ID
- CCIRF-II / 2012-1048
- Conditions
- Memory Impairment
- Keywords
- Memory, Fruitflow, Resveratrol (resVida), Cerebral blood flow, Cardiopulmonary exercise test, Maximal VO2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Neurolgy Institute for Brain Health and FitnessUniversity, hospital or other
- Collaborators
- dsm-firmenich Switzerland AG
- Study start
- Jan 2013
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 11 Jan 2013 (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.
The purpose of this study is to determine whether Fruitflow-II, Resveratrol (resVida), alone or in combination, are effective in the treatment of memory problems in adult patients with memory impairment. We also evaluate effects of these medications on blood flow to the brain and fitness, to find whether the possible improvement in memory is associated with the alterations in these parameters.
Detailed description
Accumulating evidence suggests that tomato consumption has cardiovascular benefits, primarily through increasing blood flow in vivo; the active ingredient in tomato, or its extract (Fruitflow) have been shown to inhibit glycoprotein IIb/IIIa, similar to aspirin (which has antiplatelet activity and is used for secondary prevention of cardiovascular and cerebrovascular events in patients). Considering the fact that Fruitflow can improve the platelet function and peripheral blood flow, we hypothesized that Fruitflow can also increase the blood flow in the brain and thereby possibly enhance memory and cognitive function in middle-aged or elderly people who have memory complaints. Therefore, the initial goal of our study is to evaluate the effects of Fruitflow on brain blood and cardiovascular function by using Transcranial Doppler ultrasound (to check for changes in cerebral blood flow), cardiovascular fitness testing (to check for changes in VO2-max and stroke volume), and neurocognitive evaluation (to check for changes in memory and executive function).
Many pathways such as inflammation and oxidative stress are involved in the pathophysiology of memory loss with ageing. Recent studies have shown that a natural compound found in the skin of red grapes and also in wine, called "Resveratrol", have beneficial effects for prevention of cognitive decline by reducing inflammation and improving cardiovascular function. Therefore, our next goal is to evaluate whether administration of Resveratrol, by itself or in combination with Fruitflow, can improve brain blood flow, VO2-max, and cognitive performance.
Thus our clinical trial will have the following 4 arms: Fruitflow, Resveratrol, Fruitflow/Resveratrol combination, and placebo for each supplement.
The results of the study will potentially provide evidence that these natural supplements can have significant cardioprotective and neuroprotective properties in middle-aged and elderly adults.
Subjects (between 50 and 80 years old) complaining of memory problem who have MMSE (Mini-Mental State Examination) above 27 will be recruited from patients of Dr. Majid Fotuhi (PI at the Neurology Institute for Brain Health and Fitness). Flyers at the institute and advertisement in Baltimore will provide information about the opportunity to enroll in an observational study for 3 months, along with eligibility criteria. Participants will continue to receive routine and standard care, while data on outcome (i.e., dependent) variables and mediators will be collected over three study visits:
Day 1: at the onset of their participation: Assessment of memory and Cardiovascular Fitness Testing (CFT)
Day 2: Blood Test and Transcranial Doppler (TCD) Ultrasound at time 0 and 3 hours after taking the first dose of the supplements;
Month 3: Assessment of memory, Cardiovascular Fitness Testing, and Transcranial Doppler Ultrasound 3 months after daily treatment with supplements in each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo / Placebo | No intervention | –In this control group, subjects receives placebo supplement pills without Fruitflow or ResVida ingredients. |
| Fruitflow-II / Placebo | Active comparator | Drug: Fruitflow-IIIn this group subjects receive Fruitflow-II daily supplied in capsules which contain 150 mg active ingredient. They also receive placebo capsules for resVida. |
| Placebo / resVida | Active comparator | Drug: resVidaIn this group subjects receive resVida daily supplied in capsules which contain 150 mg active ingredient. They also receive placebo capsules for Fruitflow-II. |
| Fruitflow-II / resVida | Active comparator | Drug: Fruitflow-II, Drug: resVidaIn this group subjects receive resVida and Fruitflow-II daily supplied in capsules which contain 150 mg active ingredient. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Between the ages of 50 and 80;
- Having a primary care physician;
- Ability to speak, read, and write English;
- Logical Memory subtest (of the Wechsler Memory Scale - IV [WMS-IV]) raw score one standard deviation or greater below the mean of a younger population;
- Be in stable overall health based on medical history and physical examination;
Key exclusion criteria (15 listed)
- Patients reporting severe depression with or without suicidal ideation [Beck Depression Inventory (BDI) > 30 and BDI item #9 >1];
- Patients with a severe language or hearing and/or vision impairment;
- Pregnancy;
- Patients presenting with delirium, dementia, or cognitive impairment (Mini-Mental Status Examination score < 26);
- Current alcohol or substance abuse/dependence;
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 |
|---|---|---|
| Fruitflow-II150 mg/day for 3 months, orally | Drug | Fruitflow-II / Placebo, Fruitflow-II / resVida |
| resVidaAlso: "resVida" is other name for Resveratrol.150 mg/day for 3 months, orally | Drug | Fruitflow-II / resVida, Placebo / resVida |
Primary outcome
Evidence of improvement in memory after treatment with Fruitflow-II, resVida (Resveratrol), alone or in combination
Time frame: 3 months
The following tests will be used for evaluating cognitive function: 1. Cambridge Neuropsychological Test Automated Battery (CANTAB). We use 5 tests which are mostly related to memory functioning including following: * Visual memory tests incuding (A) Paired Associates Learning (PAL) and (B) Pattern Recognition Memory (PRM) * Executive function, working memory and planning tests including (A) Stockings of Cambridge (SOC) and (B) Spatial Working Memory (SWM) * Semantic/verbal memory tests including (A) Verbal Recognition Memory (VRM) 2. Trail-Making Test (TMT) 3. Verbal Fluency Test
2 secondary outcomes
Maximal VO2 (VO2 max)
Time frame: 3 months
Blood Flow to the Brain
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2015.
- Memosyn Neurology InstituteLink provided by the sponsor.
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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.
Majid Fotuhi, MD, PhD principal investigator
Memosyn Neurology Institute
Mehrnoosh Hadadi, MD, MPH study director
Memosyn Neurology Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fruitflow-II and resVida in people with Memory Impairment, run by Neurolgy Institute for Brain Health and Fitness at 1 site in United States.
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 8 inclusion and 15 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 21 Apr 2015. 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 States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Majid Fotuhi, MD, PhD ((443) 275-1687, mfotuhi@jhu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of improvement in memory after treatment with Fruitflow-II, resVida (Resveratrol), alone or in combination (time frame: 3 months). 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 Apr 2015.