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

Mild Cognitive Impairment Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03361410
• Other study ID #: 17-001290
• Status: Completed
• Phase: Phase 2
• Start date: November 18, 2017
• Est. completion date: October 15, 2022

Study information

• Verified date: February 2023
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: October 15, 2022
• Est. primary completion date: October 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Dietary Supplement:
• Grape Powder
36 g of grape powder to be taken twice/day (total of 72 g/day) for 12 months
• Placebo Powder
36 g of placebo powder to be taken twice/day (total of 72 g/day) for 12 months

Locations

Country	Name	City	State
United States	University of California, Los Angeles	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	California Table Grape Commission

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Regional Cerebral Metabolism	Changes from baseline in regional cerebral metabolism	Baseline and 12 months
Secondary	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.	Baseline, 6 months, and 12 months
Secondary	Changes in neuropsychological performance measures: Mini-Mental State Examination	Mini-Mental State Examination (Folstein, 1975)	Baseline, 6 months, and 12 months
Secondary	Changes in neuropsychological performance measures: Wechsler Adult Intelligence Scale (WAIS-III) Digit Span	Wechsler Adult Intelligence Scale (WAIS-III) Digit Span (Wechsler, 1997)	Baseline, 6 months, and 12 months
Secondary	Changes in neuropsychological performance measures: Trail Making Test Part B	Trail Making Test Part B (Reitan, 1958)	Baseline, 6 months, and 12 months
Secondary	Changes in neuropsychological performance measures: Functional Activities Questionnaire	Functional Activities Questionnaire (Pfeffer et al., 1982)	Baseline, 6 months, and 12 months
Secondary	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.	Baseline, 6 months, and 12 months
Secondary	Changes in neuropsychological performance measures: Non-Verbal Memory	Non-Verbal Memory (measured using the NeuroTrax BrainCare application)	Baseline, 6 months, and 12 months
Secondary	Changes in neuropsychological performance measures: Verbal Function	Verbal Function (measured using the NeuroTrax BrainCare application)	Baseline, 6 months, and 12 months
Secondary	Changes in neuropsychological performance measures: Stroop Interference	Stroop Interference (measured using the NeuroTrax BrainCare application)	Baseline, 6 months, and 12 months
Secondary	Changes in neuropsychological performance measures: Problem Solving	Problem Solving (measured using the NeuroTrax BrainCare application)	Baseline, 6 months, and 12 months
Secondary	Changes in neuropsychological performance measures: Visual Spatial Processing	Visual Spatial Processing (measured using the NeuroTrax BrainCare application)	Baseline, 6 months, and 12 months