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

Memory Impairment Clinical Trial

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

Status Recruiting

Clinical 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. 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.

Clinical Trial 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Memory Impairment

• NCT number: NCT01766180
• Study type: Interventional
• Source: Neurolgy Institute for Brain Health and Fitness
• Contact: Majid Fotuhi, MD, PhD
• Phone: (443) 275-1687
• Email: mfotuhi@jhu.edu
• Status: Recruiting
• Phase: N/A
• Start date: January 2013
• Completion date: February 2016