Evaluating Whole Foods Supplementation on Cognition

Completed · Not applicable · Has a placebo group

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

In brief

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

Key facts

Study ID

NCT01672359

Run by

University of Miami

People needed

97

Starts

2011-05-01

Expected to finish

2011-12-01

Last updated by the study team

2014-08-06

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Clinical Research Building — Miami, Florida, United States

Full record on ClinicalTrials.gov

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