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

NCT03361410 | Completed Phase 2

• 1 other identifier: 17-001290
• Study Type: interventional
• Target: 32
• 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 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Regional Cerebral Metabolism

  Changes from baseline in regional cerebral metabolism

  Baseline and 12 months

Secondary Outcomes (11)

• Changes in neuropsychological performance measures

  Baseline, 6 months, and 12 months

• Changes in neuropsychological performance measures: Mini-Mental State Examination

  Baseline, 6 months, and 12 months

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

  Baseline, 6 months, and 12 months

• Changes in neuropsychological performance measures: Trail Making Test Part B

  Baseline, 6 months, and 12 months

• Changes in neuropsychological performance measures: Functional Activities Questionnaire

  Baseline, 6 months, and 12 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 12 months

Grape Powder

Placebo Powder DIETARY_SUPPLEMENT

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

Placebo Powder

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• California Table Grape Commission: collaborator

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Dementia; Alzheimer Disease; Brain Diseases; Central Nervous System Diseases

Interventions

whole grape extract

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Study Officials

• Daniel H Silverman, MD, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Molecular and Medical Pharmacology

Study Record Dates

• First Submitted: October 27, 2017
• First Posted: December 4, 2017
• Study Start: November 18, 2017
• Primary Completion: October 15, 2022
• Study Completion: October 15, 2022
• Last Updated: February 21, 2023

Record last verified: 2023-02

Locations

US (1)