Impact of Grape Consumption on Brain Metabolism and Cognitive Function - Full Text View

Purpose

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.

Condition	Intervention	Phase
Mild Cognitive Impairment	Dietary Supplement: Grape Powder Dietary Supplement: Placebo Powder	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title:	Examining the Impact of Grape Consumption on Brain Metabolism and Cognitive Function in Patients With Mild Cognitive Impairment

Resource links provided by NLM:

MedlinePlus related topics: Mild Cognitive Impairment

U.S. FDA Resources

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:

Change from baseline in neuropsychological (cognitive, functional) test results [ Time Frame: baseline and 6 months ] [ Designated as safety issue: Yes ]
Change from baseline in regional cerebral metabolism [ Time Frame: baseline and 6 months ] [ Designated as safety issue: Yes ]


Enrollment:	12
Study Start Date:	April 2012
Study Completion Date:	November 2014
Primary Completion Date:	April 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


Ages Eligible for Study:	65 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01573611

Locations


United States, California
UCLA Medical Center
Los Angeles, California, United States, 90095-6942

Sponsors and Collaborators

University of California, Los Angeles

Investigators


Principal Investigator:	Daniel H. Silverman, MD, Ph.D.	University of California, Los Angeles

More Information


Responsible Party:	Daniel H. Silverman, Professor, Molecular and Medical Pharmacology, University of California, Los Angeles
ClinicalTrials.gov Identifier:	NCT01573611 History of Changes
Other Study ID Numbers:	11002966
Study First Received:	April 5, 2012
Last Updated:	December 2, 2014
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:


mild cognitive impairment dementia positron emission tomography (PET)	F-18 Fluorodeoxyglucose (FDG) cerebral metabolism dietary supplement

Additional relevant MeSH terms:


Cognition Disorders Mild Cognitive Impairment Neurocognitive Disorders Mental Disorders

ClinicalTrials.gov processed this record on September 29, 2016