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CompletedNCT01573611Updated Dec 4, 2014

Impact of Grape Consumption on Brain Metabolism and Cognitive Function

A Phase 1 interventional study of Grape Powder and Placebo Powder in Mild Cognitive Impairment, sponsored by University of California, Los Angeles. Completed at 1 site in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2014-12-04.

Sponsored by University of California, Los Angeles · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
65 Years and older
Sex
All
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Study 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 of aged rats with grape seed extract improves cognitive performance. Despite the promising accumulating data supporting the use of grapes as a safe and effective strategy for delaying the incidence of dementia, it remains unclear how grape intake would be useful with respect to factors such as dose schedule or stage of dementing illness. In general, well-controlled experimental data obtained in human subjects is in need of much further development. The investigators aim to measure effects of grape intake on cerebral metabolism and cognitive function, 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.

Read the detailed description

People experiencing mild cognitive changes represent an epidemiologically major segment of the geriatric patient population. Numerous studies have been carried out to study the benefits of grapes associated with dementia and Alzheimer's disease (AD). In the present proposal, the investigators aim to determine 1) whether cognitive and regional cerebral metabolic changes associated with grape powder use can be identified, 2) if the presence and magnitude of therapeutic responses to grape in patients having mild cognitive decline can be predicted by particular patterns of regional brain metabolism, and 3) for any changes identified, the magnitude of those changes that correlate with the magnitude of the changes noted in the neuropsychologic parameters will be examined, which might be useful as an objective biomarker for therapeutic effect. A total of 12 patients suffering from documented decline of cognitive function (in the absence of overt dementia) will be studied. In this placebo-controlled, double-blinded study, the 12 recruited subjects who have met the screening criteria will be randomized to receive 72 g of grape powder per day or placebo. The subjects will undergo a baseline brain PET study with the radiotracer [F - 18] fluorodeoxyglucose (FDG). In addition, neuropsychological assessments will be performed at baseline and six months after initiation of therapy. Follow-up PET scans will also be obtained at six months to assess the changes in metabolism occurring with each therapy regimen.

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Conditions studied

  • Mild Cognitive Impairment

Keywords

  • mild cognitive impairment
  • dementia
  • positron emission tomography (PET)
  • F-18 Fluorodeoxyglucose (FDG)
  • cerebral metabolism
  • dietary supplement
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In context

Cognitive Dysfunction

3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.

This study's enrollment of 12 is below the median of 65 across 2,808 interventional studies indexed under Cognitive Dysfunction.

Browse Cognitive Dysfunction studies →

Lead sponsor

University of California, Los Angeles is the lead sponsor of 1,142 studies on the registry; 192 are open to participants now.

Of its 91 completed or terminated interventional studies of FDA-regulated products, 66 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Cognitive deficit and/or personality change is present, as observable by physician and/or close contact(s) of the patient; or in the absence of this, the patient provides a clear history of decline which the patient's physician deems to be reliable.
  • If history or neurologic exam reveals findings suspicious for stroke, tumor, bleed, ictal activity, or hydrocephalus, then CT/MRI and appropriate neurological or neurosurgical consultation must have been obtained.
  • Standard history, physical, and laboratory screen have been performed to identify possible presence of depression, substance abuse, malnourishment, medication effects and interactions, cardiopulmonary compromise, electrolyte/calcium imbalance, anemia, hypoxemia, infection, thyroid dysfunction, renal dysfunction, hepatic dysfunction, or glucose dysregulation.
  • Any positive findings revealed in 2) or 3) above have been appropriately treated, wherever possible, but cognitive/behavioral deficit persists post-therapy.

Exclusion criteria

Exclusion Criteria:

  • Subjects under age 65 will not be recruited, 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.
  • Already diagnosed with Alzheimer's disease or other cause of dementia
  • Cognitive dysfunction has impaired subject's ability to perform activities of daily living.
  • Present or past history of thyroid disease (due to effects of both the disease and thyroid hormone replacement therapy on brain metabolism that we and others have begun to identify, but which remain incompletely characterized.)
  • Claustrophobia or metal in body or other condition that would preclude PET or MRI from being acquired, or visual, auditory or motor deficits that would preclude accurate neuropsychological testing.
  • Currently receiving medication used specifically to treat Alzheimer's disease or other dementia-related disorder
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Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    Grape Powder

    Dietary Supplement: Grape Powder

  • Placebo comparator
    Placebo Powder

    Dietary Supplement: Placebo Powder

Interventions

  • Dietary supplementGrape Powder

    36 g of grape powder to be taken twice/day (total of 72 g/day) for 6 months

  • Dietary supplementPlacebo Powder

    36 g of placebo powder to be taken twice/day (total of 72 g/day) for 6 months

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What researchers measure

Primary outcomes

  1. Change from baseline in neuropsychological (cognitive, functional) test results

    Time frame: baseline and 6 months

  2. Change from baseline in regional cerebral metabolism

    Time frame: baseline and 6 months

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Study locations

1 site
  • UCLA Medical Center
    Los Angeles, California 90095-6942, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 4, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01573611
Lead sponsor
University of California, Los Angeles
Responsible party
Daniel H. Silverman (Professor, Molecular and Medical Pharmacology, University of California, Los Angeles) — Principal investigator
First posted
Apr 9, 2012
Start date
Apr 2012
Primary completion
Apr 2013
Completion
Nov 2014
Last update
Dec 4, 2014

Study contacts

Daniel H. Silverman, MD, Ph.D.
principal investigator · University of California, Los Angeles

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

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