Impact of Grape Consumption on Brain Metabolism and Neuropsychological Performance Over 1 Year

NCT ID: NCT03361410

Last Updated: 2023-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-18
• Study Completion Date: 2022-10-15

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 with grape seed extract in aged rats improves cognitive performance, and that supplementation with grapes in people having decline in cognition leads to preservation of metabolism in brain regions important to cognitive function over a period of six months. The investigator aims to measure effects of grape intake on cerebral metabolism and neuropsychological performance, 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 over a period of at least one year.

Detailed Description

As the number of people age 65 years old or older continues to increase, population aging has a profound impact on healthcare systems, and specifically the emergence of dementia in literally epidemic proportions. Numerous studies on the associations between grape consumption and dementia and Alzheimer's disease have found evidence to support the use of grapes and grape products as a safe and effective way to treat and delay the onset of dementia. For the present study, the Investigator aims (1) to identify regional cerebral metabolic changes associated with grape intake, (2) to determine whether the presence and magnitude of therapeutic responses to grape in patients undergoing neuroimaging evaluation for cognitive decline can be predicted by particular patterns of regional brain metabolism, and (3) to statistically assess the relationships between brain metabolism assessed by PET and cognitive function in randomized experimental arms. A total of 32 patients from a community sample of patients referred to UCLA NeuroPET Clinics by their neurologists for further evaluation by brain imaging will be studied in this placebo-controlled, double-blinded study. Subjects who have met the screening criteria will be randomized to receive 72 g of grape powder or placebo, reconstituted in water, per day. Regional brain metabolism will be measured with a PET scanner, and cognitive function will be measured by a neuropsychologic test battery assessed at baseline, 6 months following initiation of consumption, and 1 year following initiation of consumption of the grapes of placebo formulation.

Conditions

Mild Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Grape Powder

Group Type: EXPERIMENTAL

Grape Powder

Intervention Type: DIETARY_SUPPLEMENT

36 g of grape powder to be taken twice/day (total of 72 g/day) for 12 months

Placebo Powder

Group Type: PLACEBO_COMPARATOR

Placebo Powder

Intervention Type: DIETARY_SUPPLEMENT

36 g of placebo powder to be taken twice/day (total of 72 g/day) for 12 months

Interventions

Grape Powder

36 g of grape powder to be taken twice/day (total of 72 g/day) for 12 months

Intervention Type: DIETARY_SUPPLEMENT

Placebo Powder

36 g of placebo powder to be taken twice/day (total of 72 g/day) for 12 months

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Referred to the UCLA NeuroPET Clinics for concern of cognitive decline and/or behavioral changes.
• Standard history, physical, and laboratory screen performed to identify possible presence of depression, substance abuse, malnourishment, medical effects and interactions, cardiopulmonary compromise, electrolyte/calcium imbalance, anemia, hypoxemia, infection, thyroid dysfunction, renal dysfunction, hepatic dysfunction, or glucose dysregulation, and appropriate therapies administered (if any).
• Appropriate neurological consultation has been obtained, as well as CT/MRI and/or neurosurgical consultation if history or neurologic exam reveal findings suspicious for stroke, tumor, bleed, ictal activity, or hydrocephalus.

Exclusion Criteria

• Subjects under age 65 and over age 85, 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.
• Have begun cholinesterase inhibitors or memantine in the last 6 months.
• Patient lacks adequate functional status and/or caregiver support to reliably follow grape consumption regimen.
• Claustrophobia or other condition that would preclude PET from being acquired, or visual, auditory, language, or motor deficits that would preclude accurate neuropsychological testing.
• Non-English speaking subjects, due to lack of neuropsychologic testing or equivalent instruments in non-English languages.
• Subjects with a history of allergy to grapes or grape products.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

California Table Grape Commission

OTHER

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Daniel H. Silverman

Professor, Department of Molecular and Medical Pharmacology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel H Silverman, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

University of California, Los Angeles

Los Angeles, California, United States

Countries

United States

Other Identifiers

17-001290

Identifier Type: -

Identifier Source: org_study_id