Evaluating Whole Foods Supplementation on Cognition

Not Applicable

Completed

• Conditions: Sub-optimal Cognitive Function; Sub-optimal Immune Function
• Interventions: Dietary Supplement: Ginkgo Synergy® and Choline; Dietary Supplement: Placebo; Dietary Supplement: OPC Synergy® and Catalyn

• Registration Number: NCT01672359
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Study First Submitted: 2012-08-20
• Study First Submitted QC: 2012-08-23
• Study First Posted: 2012-08-24
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-04
• Last Update Posted: 2014-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ginkgo Synergy® and Choline	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)
Placebo	Placebo	cellulose pills to simulate actual products
OPC Synergy® and Catalyn	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)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 \[EGF\]

Trial Locations

Locations (1)

Clinical Research Building; 🇺🇸 Miami, Florida, United States