Trial | NCT01672359  Report issue

Title

Evaluating Whole Foods Supplementation on Cognition
The Effect of Whole-Food Dietary Supplementation on Cognitive and Immune Functioning and Quality of Life in Healthy Older Adults

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    yinhsing choline c11 ...

  • Study Participants

    97
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
Study Started
May 31
2011
Primary Completion
Dec 31
2011
Study Completion
Dec 31
2011
Last Update
Aug 06
2014
Estimate

Dietary Supplement Ginkgo Synergy® and Choline

3 tablets 2 times per day with breakfast and dinner over 6 months

Dietary Supplement OPC Synergy® and Catalyn

3 tablets 2 times per day with breakfast and dinner over 6 months

Dietary Supplement Placebo

Ginkgo Synergy® and Choline Experimental

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)

OPC Synergy® and Catalyn Experimental

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)

Placebo Placebo Comparator

cellulose pills to simulate actual products

Criteria 

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
No Results Posted