Effects of Fruitflow-II and Resveratrol on Memory, Fitness, and Cerebral Blood Flow
Effects of Fruitflow-II and Resveratrol on Memory, Fitness, and Cerebral Blood Flow
Overall Status:
Recruiting
Brief Description:
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.
Patient Qualifications:
| Min Age | Max Age | Gender | Healthy Volunteers |
|---|---|---|---|
50 Years | 80 Years | Both | Yes |
Inclusion Criteria:
- 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
Exclusion Criteria:
- Severe depression, with or without suicidal ideation
- Severe language, hearing, and/or vision impairment
- Pregnancy
- 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)
Detailed Description:
This study will evaluate the effects of taking Fruitflow-II, the powder form of a tomato extract, and resveratrol, a compound found in the skin of red grapes, to determine their effects on cognitive function, fitness level, and blood flow in the brain of people with memory complaints. Participants will take capsules every day for 3 months. Participants will take Fruitflow-II, either alone or in combination with resveratrol, or a placebo.
Accumulating evidence suggests that tomato consumption has cardiovascular benefits, primarily by increasing blood flow in the body. The researchers hypothesize that Fruitflow-II may increase blood flow in the brain and thus enhance memory and cognitive function in people with memory complaints. Resveratrol is thought to benefit cognition by reducing inflammation and improving cardiovascular function.
The results of the study could provide evidence that these natural supplements have significant cardioprotective and neuroprotective properties in middle-aged and elderly adults.
Subjects with memory problems will be recruited from the Neurology Institute for Brain Health and Fitness. Participants will undergo tests of cognitive function and cardiovascular fitness, blood tests, and ultrasound.
Locations:
| Map Marker | City | State | Zip Code | Status | Primary Contact | |
|---|---|---|---|---|---|---|
Geolocation is 39.4212175, -76.6260805 | Neurology Institute for Brain Health and Fitness | Lutherville | Maryland | 21093 | Recruiting |
Lead Sponsor:
| Agency |
|---|
Neurology Institute for Brain Health and Fitness |
Collaborator Sponsor:
| Agency |
|---|
DSM Nutritional Products, Inc. |
Facility Investigators:
| Name | Role | Affiliation |
|---|---|---|
Majid Fotuhi, MD, PhD | Principal Investigator | Neurology Institute for Brain Health and Fitness |
Mehdi Ghasemi, MD | Study Director | Neurology Institute for Brain Health and Fitness |
Study Contact:
| Name | Phone | |
|---|---|---|
Majid Fotuhi, MD, PhD | 410-494-0191 |
Locations
ClinicalTrials.gov ID
NCT01766180 (follow link to view full record on ct.gov in new window)
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
Study Start Date:
January 2013
Study End Date:
February 2015
Disease Stage:
Early
Enrollment:
80
