Recruiting

Resveratrol & Fruitflow-II

Sponsor:

Neurolgy Institute for Brain Health and Fitness

Code:

NCT01766180

Conditions

Memory Impairment

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Accepted

Interventions

Fruitflow-II

resVida

Study Details

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

Study ID

NCT01766180

Start date

Jan, 2013

Status verified date

Apr, 2015

Completion date

Feb, 2016

Anticipated

Primary completion date

Jan, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Placebo / Placebo

In this control group, subjects receives placebo supplement pills without Fruitflow or ResVida ingredients.

active comparator: Fruitflow-II / Placebo

In this group subjects receive Fruitflow-II daily supplied in capsules which contain 150 mg active ingredient. They also receive placebo capsules for resVida.

active comparator: Placebo / resVida

In this group subjects receive resVida daily supplied in capsules which contain 150 mg active ingredient. They also receive placebo capsules for Fruitflow-II.

active comparator: Fruitflow-II / resVida

In this group subjects receive resVida and Fruitflow-II daily supplied in capsules which contain 150 mg active ingredient.

Interventions

Fruitflow-II

150 mg/day for 3 months, orally

resVida

150 mg/day for 3 months, orally

Primary outcome measure

  • Evidence of improvement in memory after treatment with Fruitflow-II, resVida (Resveratrol), alone or in combination [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Majid Fotuhi, MD, PhD

(443) 275-1687mfotuhi@jhu.edu

Mehrnoosh Hadadi, MD, MPH

(443) 275-1687Mehr_Hadadi@yahoo.com

Locations

Memosyn Neurology Institute, 1205 York Road, Suite 11

Recruiting

Lutherville, Maryland, United States, 21093

Contacts

Majid Fotuhi, MD, PhD

443-275-1687mfotuhi@jhu.edu

Mehrnoosh Hadadi, MD, MPH

(443) 275-1687Mehr_Hadadi@yahoo.com

Principal Investigator:

Majid Fotuhi, MD, PhD

More Information

Sponsor

Neurolgy Institute for Brain Health and Fitness

Last update posted

Apr 21, 2015

Last verified

Apr, 2015

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Neurolgy Institute for Brain Health and Fitness on 2015-04-21.