Evaluating Whole Foods Supplementation on Cognition

Study Overview
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Brief Summary
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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

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

Conditions
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Sub-optimal Cognitive Function, Sub-optimal Immune Function

Intervention / Treatment
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* Dietary Supplement: Ginkgo Synergy® and Choline
* Dietary Supplement: OPC Synergy® and Catalyn
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ginkgo Synergy® and Choline<br>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<br>* 3 tablets 2 times per day with breakfast and dinner over 6 months<br>|
| Experimental: OPC Synergy® and Catalyn<br>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<br>* 3 tablets 2 times per day with breakfast and dinner over 6 months<br>|
| Placebo Comparator: Placebo<br>cellulose pills to simulate actual products | Dietary Supplement: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive Measures | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cognitive functioning, immune function, cytokines, growth factors, quality of life, dietary supplementation, Ginkgo biloba, Improvement of cognitive function