Impact of Grape Consumption on Brain Metabolism and Cognitive Function
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ClinicalTrials.gov Identifier: NCT01573611 |
Recruitment Status :
Completed
First Posted : April 9, 2012
Last Update Posted : December 4, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Mild Cognitive Impairment | Dietary Supplement: Grape Powder Dietary Supplement: Placebo Powder | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 12 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Official Title: | Examining the Impact of Grape Consumption on Brain Metabolism and Cognitive Function in Patients With Mild Cognitive Impairment |
Study Start Date : | April 2012 |
Actual Primary Completion Date : | April 2013 |
Actual Study Completion Date : | November 2014 |
Arm | Intervention/treatment |
---|---|
Experimental: Grape Powder |
Dietary Supplement: Grape Powder
36 g of grape powder to be taken twice/day (total of 72 g/day) for 6 months |
Placebo Comparator: Placebo Powder |
Dietary Supplement: Placebo Powder
36 g of placebo powder to be taken twice/day (total of 72 g/day) for 6 months |
- Change from baseline in neuropsychological (cognitive, functional) test results [ Time Frame: baseline and 6 months ]
- Change from baseline in regional cerebral metabolism [ Time Frame: baseline and 6 months ]

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Ages Eligible for Study: | 65 Years and older (Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01573611
United States, California | |
UCLA Medical Center | |
Los Angeles, California, United States, 90095-6942 |
Principal Investigator: | Daniel H. Silverman, MD, Ph.D. | University of California, Los Angeles |
Responsible Party: | Daniel H. Silverman, Professor, Molecular and Medical Pharmacology, University of California, Los Angeles |
ClinicalTrials.gov Identifier: | NCT01573611 |
Other Study ID Numbers: |
11002966 |
First Posted: | April 9, 2012 Key Record Dates |
Last Update Posted: | December 4, 2014 |
Last Verified: | December 2014 |
mild cognitive impairment dementia positron emission tomography (PET) |
F-18 Fluorodeoxyglucose (FDG) cerebral metabolism dietary supplement |
Cognitive Dysfunction Cognition Disorders Neurocognitive Disorders Mental Disorders |