Evaluating Whole Foods Supplementation on Cognition

University of Miami

Status: Completed

Conditions: Sub-optimal Cognitive Function; Sub-optimal Immune Function

Treatments: Dietary Supplement: OPC Synergy® and Catalyn; Dietary Supplement: Ginkgo Synergy® and Choline; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01672359

20090985

Details and patient eligibility

About

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

Enrollment: 97 patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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97 participants in 3 patient groups, including a placebo group

Ginkgo Synergy® and Choline

Experimental group

Description:

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)

Treatment:

Dietary Supplement: Ginkgo Synergy® and Choline

OPC Synergy® and Catalyn

Experimental group

Description:

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)

Treatment:

Dietary Supplement: OPC Synergy® and Catalyn

Placebo

Placebo Comparator group

Description:

cellulose pills to simulate actual products

Treatment:

Dietary Supplement: Placebo