Impact of Grape Consumption on Brain Metabolism and Cognitive Function

NCT01573611 | Completed Phase 1 DMC

• 1 other identifier: 11002966
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mild Cognitive Impairment

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Change from baseline in neuropsychological (cognitive, functional) test results

  baseline and 6 months

• Change from baseline in regional cerebral metabolism

  baseline and 6 months

Study Arms (2)

Grape Powder

EXPERIMENTAL

Dietary Supplement: Grape Powder

Placebo Powder

PLACEBO COMPARATOR

Dietary Supplement: Placebo Powder

Interventions

Grape Powder DIETARY_SUPPLEMENT

36 g of grape powder to be taken twice/day (total of 72 g/day) for 6 months

Grape Powder

Placebo Powder DIETARY_SUPPLEMENT

36 g of placebo powder to be taken twice/day (total of 72 g/day) for 6 months

Placebo Powder

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA Medical Center

Los Angeles, California, 90095-6942, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Dementia

Interventions

whole grape extract

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Daniel H. Silverman, MD, Ph.D.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Molecular and Medical Pharmacology

Study Record Dates

• First Submitted: April 5, 2012
• First Posted: April 9, 2012
• Study Start: April 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: November 1, 2014
• Last Updated: December 4, 2014

Record last verified: 2014-12

Locations

US (1)