Evaluating Whole Foods Supplementation on Cognition

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01672359
Recruitment Status : Completed
First Posted : August 24, 2012
Last Update Posted : August 6, 2014
Standard Process Inc.
Information provided by (Responsible Party):
John E. Lewis, University of Miami

Brief Summary:
A six-month study which investigated the effect of Ginkgo Synergy® and Choline or OPC Synergy® and Catalyn® on cognitive and immune function markers and quality of life among healthy older adults with no history of significant cognitive deficits

Condition or disease Intervention/treatment Phase
Sub-optimal Cognitive Function Sub-optimal Immune Function Dietary Supplement: Ginkgo Synergy® and Choline Dietary Supplement: OPC Synergy® and Catalyn Dietary Supplement: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Whole-Food Dietary Supplementation on Cognitive and Immune Functioning and Quality of Life in Healthy Older Adults
Study Start Date : May 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Ginkgo Synergy® and Choline
Ginkgo Synergy® (120 mg/day Ginkgo biloba leaf with 80 mg/day Ginkgo biloba whole extract combined with 40 mg/day Grape Seed extract) and Choline (700 mg choline/day)
Dietary Supplement: Ginkgo Synergy® and Choline
3 tablets 2 times per day with breakfast and dinner over 6 months
Experimental: OPC Synergy® and Catalyn
OPC Synergy® (100 mg/day of Grape Seed extract with 50 mg/day Green Tea extract (60% catechins)) and Catalyn® (1,248 IU/day of Vitamin D, 4,800 IU/day of Vitamin A, combined with vitamin C, thiamine, riboflavin, and vitamin B6)
Dietary Supplement: OPC Synergy® and Catalyn
3 tablets 2 times per day with breakfast and dinner over 6 months
Placebo Comparator: Placebo
cellulose pills to simulate actual products
Dietary Supplement: Placebo

Primary Outcome Measures :
  1. Cognitive Measures [ Time Frame: 6 months ]
    The measures included the MMSE, the Stroop Color and Word Test (SCWT), the Trail Making Test Parts A and B (TMT-A, TMT-B), the Controlled Oral Word Association test (COWA), the Digit Symbol subtest of the Wechsler Adult Intelligence Scale, Third Edition (WAIS-III), and the Hopkins Verbal Learning Test-Revised (HVLT-R)

Secondary Outcome Measures :
  1. Quality of Life Measures [ Time Frame: 6 months ]
    Quality of Well-Being Scale (QWBS) Medical Outcomes Study Short Form 36 (SF 36) Beck Depression Inventory (BDI) Beck Anxiety Inventory (BAI)

  2. Immune Function Markers [ Time Frame: 6 months ]
    interleukin [IL]-2, IL-4, IL-6, IL-8, IL-10, IL-1α, IL-1β, interferon [IFN]-γ, tumor necrosis factor [TNF]-α, monocyte chemotactic protein [MCP]-1, vascular endothelial growth factor [VEGF], and epidermal growth factor [EGF]

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 60 years of age and older
  • English speaking
  • Not living in a skilled or intermediate care level nursing facility
  • No use of dietary supplements for cognitive functioning two weeks before enrolling in the study and during the length of the trial
  • A Mini-Mental State Exam (MMSE) score ≥ 23

Exclusion Criteria:

  • A cognitive deficit greater than that indicated according to the MMSE score
  • A clinical diagnosis of AD and/or related disorders
  • A psychiatric diagnosis of schizophrenia, other psychotic disorders, bipolar disorder, major depression with psychotic features, delirium, and alcohol or substance abuse/dependence
  • Bleeding disorders
  • Aphasia or sensory, motor, and/or visual disturbances that would have interfered with psychometric tests
  • Gastrointestinal disorders causing impaired absorption of the study supplements
  • Insulin-dependent diabetes
  • Major conditions such as cardiovascular, pulmonary, renal, thyroid, hepatic, gastrointestinal, or seizure
  • Hematologic or oncologic disorders treated with chemotherapy in the previous two years
  • Active chemotherapy or radiation treatment for cancer
  • Current cigarette smoking
  • More than three major medical or psychiatric hospitalizations in the past year
  • Diagnosis of a terminal illness
  • A T score > 70 on the Global Severity Index of the Brief Symptoms Inventory (BSI)
  • A score ≥ 29 on the Beck Depression Inventory-II (BDI) (15)
  • Prescription and OTC sympathomimetic amines and antihistamines within 2 days of an assessment visit
  • Cognition enhancing drugs consumption such as Donepezil, Rivastigmine, Galantamine, and Tacrine
  • Coumadin, tricyclic antidepressants, antipsychotics, and anticonvulsants
  • Cognition-enhancing supplements, herbs, or antioxidants that could not be stopped during the trial
  • Participating in a concurrent trial for drugs, supplements, or treatment that affects behavior or cognitive function

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01672359

United States, Florida
Clinical Research Building
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Standard Process Inc.
Principal Investigator: John Lewis, PhD University of Miami

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: John E. Lewis, Associate Professor, University of Miami Identifier: NCT01672359     History of Changes
Other Study ID Numbers: 20090985
First Posted: August 24, 2012    Key Record Dates
Last Update Posted: August 6, 2014
Last Verified: August 2014

Keywords provided by John E. Lewis, University of Miami:
cognitive functioning
immune function
growth factors
quality of life
dietary supplementation
Ginkgo biloba
Improvement of cognitive function

Additional relevant MeSH terms:
Grape Seed Extract
Lipotropic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Lipid Regulating Agents
Nootropic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Protective Agents
Physiological Effects of Drugs