Impact of Grape Consumption on Brain Metabolism and Neuropsychological Performance Over 1 Year
Condition: Mild Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): Grape Powder; Placebo Powder
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 36 g of grape powder to be taken twice/day (total of 72 g/day) for 12 months; 36 g of placebo powder to be taken twice/day (total of 72 g/day) for 12 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
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