Evaluating Whole Foods Supplementation on Cognition

August 4, 2014 updated by: John E. Lewis, University of Miami

The Effect of Whole-Food Dietary Supplementation on Cognitive and Immune Functioning and Quality of Life in Healthy Older Adults

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

97

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • Clinical Research Building

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
6 months
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]
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Collaborators

Standard Process Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

August 20, 2012

First Submitted That Met QC Criteria

August 23, 2012

First Posted (Estimate)

August 24, 2012

Study Record Updates

Last Update Posted (Estimate)

August 6, 2014

Last Update Submitted That Met QC Criteria

August 4, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20090985

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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