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

• Status: Unknown status
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Neurolgy Institute for Brain Health and Fitness
• Collaborator: DSM Nutritional Products, Inc.
• Treatments: Resveratrol

Criteria

Inclusion Criteria:

1. Between the ages of 50 and 80;

2. Having a primary care physician;

3. Ability to speak, read, and write English;

4. 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;

5. Be in stable overall health based on medical history and physical examination;

6. Sedentary or moderately active (< 2 aerobic session / week);

7. 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;

8. Wine intake not more than 2 glasses per day

Exclusion Criteria:

1. Patients reporting severe depression with or without suicidal ideation [Beck Depression Inventory (BDI) > 30 and BDI item #9 >1];

2. Patients with a severe language or hearing and/or vision impairment;

3. Pregnancy;

4. Patients presenting with delirium, dementia, or cognitive impairment (Mini-Mental Status Examination score < 26);

5. Current alcohol or substance abuse/dependence;

6. 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;

7. 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);

8. 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;

9. Current hepatic failure, renal failure, bleeding disorders (hemophilia, Von Willebrand disease, esophageal varicoses);

10. Subjects who have given 500 ml of blood or more for transfusion purposes in the past month before entry into the study

11. Patients who take aspirin more than 325 mg/day

12. Current medications for cognition such as acetylcholine esterase inhibitors (e.g., tacrine, donepezil, galantamine, rivastigmin) and memantine;

13. Known history of allergies to tomatoes or tomato-based products;

14. 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.