Sub-optimal Cognitive Function, Sub-optimal Immune Function
Conditions
Keywords
cognitive functioning, immune function, cytokines, growth factors, quality of life, dietary supplementation, Ginkgo biloba, Improvement of cognitive function
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
Interventions
DIETARY_SUPPLEMENTGinkgo Synergy® and Choline
3 tablets 2 times per day with breakfast and dinner over 6 months
DIETARY_SUPPLEMENTOPC Synergy® and Catalyn
3 tablets 2 times per day with breakfast and dinner over 6 months
DIETARY_SUPPLEMENTPlacebo
Sponsors
Standard Process Inc.
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive Measures | 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
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life Measures | 6 months | 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 | 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 \[EGF\] |
Countries
United States
Outcome results
None listed