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

February 17, 2023 updated by: Daniel H. Silverman, University of California, Los Angeles

Examining the Impact of Grape Consumption on Brain Metabolism and Neuropsychological Performance in Patients Undergoing Neuroimaging Evaluation for Cognitive Decline: A Double-blinded Placebo Controlled Expansion Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 2

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

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • University of California, Los Angeles

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 to 85 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 12 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 12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Regional Cerebral Metabolism
Time Frame: Baseline and 12 months
Changes from baseline in regional cerebral metabolism
Baseline and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in neuropsychological performance measures
Time Frame: Baseline, 6 months, and 12 months
Changes in cognitive performance over time within each group will be measured through the neuropsychological assessments listed below, as administered by trained psychometrists under direct supervision of a licensed neuropsychologist, and will be correlated with changes in regional cerebral metabolism.
Baseline, 6 months, and 12 months
Changes in neuropsychological performance measures: Mini-Mental State Examination
Time Frame: Baseline, 6 months, and 12 months
Mini-Mental State Examination (Folstein, 1975)
Baseline, 6 months, and 12 months
Changes in neuropsychological performance measures: Wechsler Adult Intelligence Scale (WAIS-III) Digit Span
Time Frame: Baseline, 6 months, and 12 months
Wechsler Adult Intelligence Scale (WAIS-III) Digit Span (Wechsler, 1997)
Baseline, 6 months, and 12 months
Changes in neuropsychological performance measures: Trail Making Test Part B
Time Frame: Baseline, 6 months, and 12 months
Trail Making Test Part B (Reitan, 1958)
Baseline, 6 months, and 12 months
Changes in neuropsychological performance measures: Functional Activities Questionnaire
Time Frame: Baseline, 6 months, and 12 months
Functional Activities Questionnaire (Pfeffer et al., 1982)
Baseline, 6 months, and 12 months
Changes in neuropsychological performance measures: Verbal Memory
Time Frame: Baseline, 6 months, and 12 months
NeuroTrax BrainCare, a cloud-based computer application that includes a series of tests and associated reports, will be used to measure Verbal Memory.
Baseline, 6 months, and 12 months
Changes in neuropsychological performance measures: Non-Verbal Memory
Time Frame: Baseline, 6 months, and 12 months
Non-Verbal Memory (measured using the NeuroTrax BrainCare application)
Baseline, 6 months, and 12 months
Changes in neuropsychological performance measures: Verbal Function
Time Frame: Baseline, 6 months, and 12 months
Verbal Function (measured using the NeuroTrax BrainCare application)
Baseline, 6 months, and 12 months
Changes in neuropsychological performance measures: Stroop Interference
Time Frame: Baseline, 6 months, and 12 months
Stroop Interference (measured using the NeuroTrax BrainCare application)
Baseline, 6 months, and 12 months
Changes in neuropsychological performance measures: Problem Solving
Time Frame: Baseline, 6 months, and 12 months
Problem Solving (measured using the NeuroTrax BrainCare application)
Baseline, 6 months, and 12 months
Changes in neuropsychological performance measures: Visual Spatial Processing
Time Frame: Baseline, 6 months, and 12 months
Visual Spatial Processing (measured using the NeuroTrax BrainCare application)
Baseline, 6 months, and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Collaborators

California Table Grape Commission

Investigators

  • Principal Investigator: Daniel H Silverman, MD, PhD, 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 (Actual)

November 18, 2017

Primary Completion (Actual)

October 15, 2022

Study Completion (Actual)

October 15, 2022

Study Registration Dates

First Submitted

October 27, 2017

First Submitted That Met QC Criteria

November 28, 2017

First Posted (Actual)

December 4, 2017

Study Record Updates

Last Update Posted (Estimate)

February 21, 2023

Last Update Submitted That Met QC Criteria

February 17, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-001290

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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