Evaluating Whole Foods Supplementation on Cognition

This study has been completed.
Sponsor:
Collaborator:
Standard Process, Inc.
Information provided by (Responsible Party):
John E. Lewis, University of Miami
ClinicalTrials.gov Identifier:
NCT01672359
First received: August 20, 2012
Last updated: August 23, 2012
Last verified: August 2012
  Purpose

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 Intervention
Improvement of Cognitive Functions
Dietary Supplement: Ginkgo Synergy® and Choline
Dietary Supplement: OPC Synergy® and Catalyn
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by University of Miami:

Primary Outcome Measures:
  • Cognitive Measures [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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:
  • Quality of Life Measures [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Quality of Well-Being Scale (QWBS) Medical Outcomes Study Short Form 36 (SF 36) Beck Depression Inventory (BDI) Beck Anxiety Inventory (BAI)

  • Immune Function Markers [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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]


Enrollment: 97
Study Start Date: May 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01672359

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

No publications provided by University of Miami

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: John E. Lewis, Director of Research, University of Miami
ClinicalTrials.gov Identifier: NCT01672359     History of Changes
Other Study ID Numbers: 20090985
Study First Received: August 20, 2012
Last Updated: August 23, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Miami:
cognitive functioning
immune function
cytokines
growth factors
quality of life
dietary supplementation
Ginkgo biloba
Improvement of cognitive functions of healthy older adults with no history of significant cognitive deficits

Additional relevant MeSH terms:
Choline
Lipotropic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Gastrointestinal Agents
Therapeutic Uses
Lipid Regulating Agents
Nootropic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 16, 2014