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

Primary Purpose

Mild Cognitive Impairment

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Grape Powder

Placebo Powder

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring Mild Decline in Cognition, Mild Cognitive Decline, Mild Cognitive Impairment, Dementia, Positron Emission Tomography (PET), F-18 Fluorodeoxyglucose (FDG), Cerebral Metabolism, Dietary Supplement, MCI, MDC, Grape, Memory, Randomized, Non-Drug, Supplement, Non-Pharmacologic, Natural, Red Wine, Free, UCLA, Brain Scan, Alzheimer's Disease, Brain Diseases, Central Nervous System Diseases, Cognition, Cognitive, Neurocognitive, Neurodegenerative

Eligibility Criteria

65 Years - 85 Years (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of California, Los Angeles

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Grape Powder

Placebo Powder

Arm Description

Outcomes

Primary Outcome Measures

Regional Cerebral Metabolism

Changes from baseline in regional cerebral metabolism

Secondary Outcome Measures

Changes in neuropsychological performance measures

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.

Changes in neuropsychological performance measures: Mini-Mental State Examination

Mini-Mental State Examination (Folstein, 1975)

Changes in neuropsychological performance measures: Wechsler Adult Intelligence Scale (WAIS-III) Digit Span

Wechsler Adult Intelligence Scale (WAIS-III) Digit Span (Wechsler, 1997)

Changes in neuropsychological performance measures: Trail Making Test Part B

Trail Making Test Part B (Reitan, 1958)

Changes in neuropsychological performance measures: Functional Activities Questionnaire

Functional Activities Questionnaire (Pfeffer et al., 1982)

Changes in neuropsychological performance measures: Verbal Memory

NeuroTrax BrainCare, a cloud-based computer application that includes a series of tests and associated reports, will be used to measure Verbal Memory.

Changes in neuropsychological performance measures: Non-Verbal Memory

Non-Verbal Memory (measured using the NeuroTrax BrainCare application)

Changes in neuropsychological performance measures: Verbal Function

Verbal Function (measured using the NeuroTrax BrainCare application)

Changes in neuropsychological performance measures: Stroop Interference

Stroop Interference (measured using the NeuroTrax BrainCare application)

Changes in neuropsychological performance measures: Problem Solving

Problem Solving (measured using the NeuroTrax BrainCare application)

Changes in neuropsychological performance measures: Visual Spatial Processing

Visual Spatial Processing (measured using the NeuroTrax BrainCare application)

Full Information

NCT ID

NCT03361410

First Posted

October 27, 2017

Last Updated

February 17, 2023

Sponsor

University of California, Los Angeles

Collaborators

California Table Grape Commission

1. Study Identification

Unique Protocol Identification Number

NCT03361410

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Completed

Study Start Date

November 18, 2017 (Actual)

Primary Completion Date

October 15, 2022 (Actual)

Study Completion Date

October 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, Los Angeles

Collaborators

California Table Grape Commission

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mild Cognitive Impairment

Keywords

Mild Decline in Cognition, Mild Cognitive Decline, Mild Cognitive Impairment, Dementia, Positron Emission Tomography (PET), F-18 Fluorodeoxyglucose (FDG), Cerebral Metabolism, Dietary Supplement, MCI, MDC, Grape, Memory, Randomized, Non-Drug, Supplement, Non-Pharmacologic, Natural, Red Wine, Free, UCLA, Brain Scan, Alzheimer's Disease, Brain Diseases, Central Nervous System Diseases, Cognition, Cognitive, Neurocognitive, Neurodegenerative

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Grape Powder

Arm Type

Experimental

Arm Title

Placebo Powder

Arm Type

Placebo Comparator

Intervention Type

Dietary Supplement

Intervention Name(s)

Grape Powder

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo Powder

Intervention Description

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

Primary Outcome Measure Information:

Title

Regional Cerebral Metabolism

Description

Changes from baseline in regional cerebral metabolism

Time Frame

Baseline and 12 months

Secondary Outcome Measure Information:

Title

Changes in neuropsychological performance measures

Description

Time Frame