- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01573611
Impact of Grape Consumption on Brain Metabolism and Cognitive Function
December 2, 2014 updated by: Daniel H. Silverman, University of California, Los Angeles
Examining the Impact of Grape Consumption on Brain Metabolism and Cognitive Function in Patients With Mild Cognitive Impairment
Constituents of grapes have been studied for their antioxidant, anti-inflammatory, and anticarcinogenic properties.
In the past decade, there has been emerging evidence regarding a potential role for grapes in slowing cognitive decline and other effects of aging.
Furthermore, evidence has been obtained in vivo that supplementation of aged rats with grape seed extract improves cognitive performance.
Despite the promising accumulating data supporting the use of grapes as a safe and effective strategy for delaying the incidence of dementia, it remains unclear how grape intake would be useful with respect to factors such as dose schedule or stage of dementing illness.
In general, well-controlled experimental data obtained in human subjects is in need of much further development.
The investigators aim to measure effects of grape intake on cerebral metabolism and cognitive function, and to determine whether initial patterns, and magnitude of change, of cerebral metabolism assessed by positron emission tomography (PET) can serve respectively as a predictor of, and biomarker for, the magnitude of cognitive changes resulting from intake of grapes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
People experiencing mild cognitive changes represent an epidemiologically major segment of the geriatric patient population.
Numerous studies have been carried out to study the benefits of grapes associated with dementia and Alzheimer's disease (AD).
In the present proposal, the investigators aim to determine 1) whether cognitive and regional cerebral metabolic changes associated with grape powder use can be identified, 2) if the presence and magnitude of therapeutic responses to grape in patients having mild cognitive decline can be predicted by particular patterns of regional brain metabolism, and 3) for any changes identified, the magnitude of those changes that correlate with the magnitude of the changes noted in the neuropsychologic parameters will be examined, which might be useful as an objective biomarker for therapeutic effect.
A total of 12 patients suffering from documented decline of cognitive function (in the absence of overt dementia) will be studied.
In this placebo-controlled, double-blinded study, the 12 recruited subjects who have met the screening criteria will be randomized to receive 72 g of grape powder per day or placebo.
The subjects will undergo a baseline brain PET study with the radiotracer [F - 18] fluorodeoxyglucose (FDG).
In addition, neuropsychological assessments will be performed at baseline and six months after initiation of therapy.
Follow-up PET scans will also be obtained at six months to assess the changes in metabolism occurring with each therapy regimen.
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Los Angeles, California, United States, 90095-6942
- UCLA Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Cognitive deficit and/or personality change is present, as observable by physician and/or close contact(s) of the patient; or in the absence of this, the patient provides a clear history of decline which the patient's physician deems to be reliable.
- If history or neurologic exam reveals findings suspicious for stroke, tumor, bleed, ictal activity, or hydrocephalus, then CT/MRI and appropriate neurological or neurosurgical consultation must have been obtained.
- Standard history, physical, and laboratory screen have been performed to identify possible presence of depression, substance abuse, malnourishment, medication effects and interactions, cardiopulmonary compromise, electrolyte/calcium imbalance, anemia, hypoxemia, infection, thyroid dysfunction, renal dysfunction, hepatic dysfunction, or glucose dysregulation.
- Any positive findings revealed in 2) or 3) above have been appropriately treated, wherever possible, but cognitive/behavioral deficit persists post-therapy.
Exclusion Criteria:
- Subjects under age 65 will not be recruited, in order to enhance the clinical relevance of the project by focusing on the age groups in whom serious concerns about early signs and symptoms of senile onset dementia are most typically emerging.
- Already diagnosed with Alzheimer's disease or other cause of dementia
- Cognitive dysfunction has impaired subject's ability to perform activities of daily living.
- Present or past history of thyroid disease (due to effects of both the disease and thyroid hormone replacement therapy on brain metabolism that we and others have begun to identify, but which remain incompletely characterized.)
- Claustrophobia or metal in body or other condition that would preclude PET or MRI from being acquired, or visual, auditory or motor deficits that would preclude accurate neuropsychological testing.
- Currently receiving medication used specifically to treat Alzheimer's disease or other dementia-related disorder
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Grape Powder
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36 g of grape powder to be taken twice/day (total of 72 g/day) for 6 months
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PLACEBO_COMPARATOR: Placebo Powder
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36 g of placebo powder to be taken twice/day (total of 72 g/day) for 6 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in neuropsychological (cognitive, functional) test results
Time Frame: baseline and 6 months
|
baseline and 6 months
|
Change from baseline in regional cerebral metabolism
Time Frame: baseline and 6 months
|
baseline and 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Daniel H. Silverman, MD, Ph.D., University of California, Los Angeles
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2012
Primary Completion (ACTUAL)
April 1, 2013
Study Completion (ACTUAL)
November 1, 2014
Study Registration Dates
First Submitted
April 5, 2012
First Submitted That Met QC Criteria
April 5, 2012
First Posted (ESTIMATE)
April 9, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
December 4, 2014
Last Update Submitted That Met QC Criteria
December 2, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11002966
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Mild Cognitive Impairment
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University of California, San FranciscoNational Institute on Aging (NIA)RecruitingMild Cognitive Impairment | Cognitive Decline | Cognitive Deterioration | Cognitive Impairment, Mild | Cognitive Deficits, MildUnited States
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BaycrestCentre for Aging and Brain Health InnovationUnknownNeurocognitive Disorders | Cognitive Dysfunction | Mental Disorder | Cognitive Impairment, Mild | Cognitive Disorder | Nonamnestic Mild Cognitive ImpairmentCanada
-
Mackay Memorial HospitalBened Biomedical Co., Ltd.RecruitingMild Cognitive Impairment (MCI)Taiwan
-
Thomas Jefferson UniversityJohns Hopkins University; University of Pennsylvania; National Institute on Aging... and other collaboratorsCompletedMild Cognitive Impairment (MCI)United States
-
Palo Alto Veterans Institute for ResearchU.S. Army Medical Research and Development CommandCompletedAmnestic Mild Cognitive ImpairmentUnited States
-
Assaf-Harofeh Medical CenterNeurim Pharmaceuticals Ltd.UnknownMild Cognitive Impairment (MCI)Israel
-
Centre for Addiction and Mental HealthRecruitingAmnestic Mild Cognitive ImpairmentCanada
-
University of FloridaNational Institute on Aging (NIA)RecruitingAmnestic Mild Cognitive ImpairmentUnited States
-
Charite University, Berlin, GermanyCompletedMild Cognitive Impairment (MCI)Germany
-
Johns Hopkins UniversityNational Institute on Aging (NIA)CompletedMild Cognitive Impairment (MCI)United States
Clinical Trials on Grape Powder
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University of Alabama at BirminghamCompleted
-
University of California, DavisCompletedInflammation | Obesity | Cardiovascular Disease | Oxidative StressUnited States
-
USDA, Western Human Nutrition Research CenterCompletedInflammation | ObesityUnited States
-
National University of SingaporeCalifornia Table Grape CommissionNot yet recruitingAging | Macula; Degeneration | Advanced Glycation End Products
-
University of ConnecticutCalifornia Table Grape CommissionCompletedMetabolic Syndrome XUnited States
-
National University of SingaporeNational University Hospital, Singapore; Ministry of Education, SingaporeActive, not recruitingAge-related Macular Degeneration | Eye HealthSingapore
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University of ArizonaTerminatedCardiovascular Risk FactorUnited States
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University of California, Los AngelesCalifornia Table Grape CommissionCompletedMild Cognitive ImpairmentUnited States
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University of CincinnatiU.S. Highbush Blueberry Council; Welch Foods IncorporatedCompleted
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California State Polytechnic University, PomonaNot yet recruitingHealthy PeopleUnited States