Cerebrovascular and Cognitive Improvement by Resveratrol (resVida) and Fruitflow-II (CCIRF-II)

NCT01766180 | Unknown DMC

• 1 other identifier: 2012-1048
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Memory Impairment

Keywords

Memory; Fruitflow; Resveratrol (resVida); Cerebral blood flow; Cardiopulmonary exercise test; Maximal VO2

Outcome Measures

Primary Outcomes (1)

• 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: 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

  3 months

Secondary Outcomes (2)

• Maximal VO2 (VO2 max)

  3 months

• Blood Flow to the Brain

  3 months

Study Arms (4)

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.

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.

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.

Drug: Fruitflow-II; Drug: resVida

Interventions

Fruitflow-II DRUG

150 mg/day for 3 months, orally

Fruitflow-II / Placebo; Fruitflow-II / resVida

resVida DRUG

150 mg/day for 3 months, orally

Also known as: "resVida" is other name for Resveratrol.

Fruitflow-II / resVida; Placebo / resVida

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;
• 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:
• 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.

Sponsors & Collaborators

• Neurolgy Institute for Brain Health and Fitness: lead
• DSM Nutritional Products, Inc.: collaborator

Study Sites (1)

Memosyn Neurology Institute, 1205 York Road, Suite 11

Lutherville, Maryland, 21093, United States

RECRUITING

Related Links

• Memosyn Neurology Institute

MeSH Terms

Conditions

Memory Disorders

Interventions

Resveratrol

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Stilbestrols; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polyphenols; Phenols

Study Officials

• Majid Fotuhi, MD, PhD

  Memosyn Neurology Institute

  PRINCIPAL INVESTIGATOR

• Mehrnoosh Hadadi, MD, MPH

  Memosyn Neurology Institute

  STUDY DIRECTOR

Central Study Contacts

Majid Fotuhi, MD, PhD

CONTACT

(443) 275-1687; mfotuhi@jhu.edu

Mehrnoosh Hadadi, MD, MPH

CONTACT

(443) 275-1687; Mehr_Hadadi@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Founder and Medical Chief Officer

Study Record Dates

• First Submitted: January 8, 2013
• First Posted: January 11, 2013
• Study Start: January 1, 2013
• Primary Completion: January 1, 2016
• Study Completion: February 1, 2016
• Last Updated: April 21, 2015

Record last verified: 2015-04

Locations

US (1)