Start: January 2013
End: February 2016
What Is This Study About?
The purpose of this study is to determine whether Fruitflow-II (a tomato extract), resveratrol (a compound found in the skin of red grapes and wine), alone or in combination, can effectively treat memory problems in older adult patients with memory impairment. Researchers will also evaluate their effects on blood flow to the brain and fitness.
Do I Qualify To Participate in This Study?
- Participant has a primary care physician.
- Ability to speak, read, and write English
- Raw score on the Logical Memory subtest of the Wechsler Memory Scale IV is one standard deviation or greater below the mean of a younger population
- Stable overall health based on medical history and physical examination
- Sedentary or moderately active (fewer than two aerobic exercise sessions per week)
- Willingness to suspend, for at least 1 month before participating in the study, the use of dietary supplements such as fish oil, seed oils, ginkgo biloba, ginseng, resveratrol, fruit powder extracts and DHA. Subjects who have high intake of these products may be recruited into the study after stopping them for 4 weeks. No more than one multivitamin per day.
- Wine intake of no more than two glasses per day
Must NOT have:
- Severe depression, with or without suicidal ideation
- Severe language, hearing, and/or vision impairment
- Delirium, dementia, or cognitive impairment (Mini-Mental Status Examination score of less than 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 (more than 180/100 mmHg) or documented record of related, uncontrolled complications such as cerebral vascular disease and/or large strokes with disability, uncontrolled diabetes mellitus, or history of major cardiopulmonary disease such as congestive heart failure, chronic obstructive pulmonary disease, pulmonary embolism
- Documented evidence of low levels of platelets, hematocrit, or hemoglobin; prothrombin time (PT) values outside normal range of approximately 10-16 seconds
- Current hepatic failure, renal failure, bleeding disorders (hemophilia, Von Willebrand disease, esophageal varicoses)
- Gave 500 ml of blood or more for transfusion purposes in the month before study entry
- Take more than 325 mg/day of aspirin; take Alzheimer's medications such as acetylcholinesterase inhibitors or 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 (more than five times per day)
If I Qualify, Who Do I Contact?
Contact study personnel listed either under the general study contact or the location nearest you.
Majid Fotuhi, MD, PhD
Mehrnoosh Hadadi, MD, MPH
Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.
Where Is This Study Located?
Memosyn Neurology Institute, 1205 York Road, Suite 11
Lutherville, MD 21093
Majid Fotuhi, MD, PhD
Lead: Memosyn Neurology Institute
DSM Nutritional Products, Inc.
Source: ClinicalTrials.gov ID: NCT01766180