Completed
The Effect of Whole-Food Dietary Supplementation on Cognitive and Immune Functioning and Quality of Life in Healthy Older Adults
What is being tested
Ginkgo Synergy® and Choline
+ OPC Synergy® and Catalyn
+ Placebo
Dietary Supplement
Who is being recruted
Over 60 Years
+25 Eligibility Criteria
How is the trial designed
Prevention Study
Placebo-Controlled
Interventional
Study Start: May 2011
Summary
Principal SponsorUniversity of Miami
Last updated: August 6, 2014
Sourced from a government-validated database.Claim as a partner
Study start date: May 1, 2011
Actual date on which the first participant was enrolled.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
Principal SponsorUniversity of Miami
Last updated: August 6, 2014
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
97 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 60 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
5 inclusion criteria required to participate
60 years of age and older
A Mini-Mental State Exam (MMSE) score >= 23
English speaking
No use of dietary supplements for cognitive functioning two weeks before enrolling in the study and during the length of the trial
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20 exclusion criteria prevent from participating
A T score > 70 on the Global Severity Index of the Brief Symptoms Inventory (BSI)
A clinical diagnosis of AD and/or related disorders
A cognitive deficit greater than that indicated according to the MMSE score
A psychiatric diagnosis of schizophrenia, other psychotic disorders, bipolar disorder, major depression with psychotic features, delirium, and alcohol or substance abuse/dependence
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Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
3 intervention groups are designated in this study
33.333% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGinkgo 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)
Group II
ExperimentalOPC 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)
Group III
Placebocellulose pills to simulate actual products
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
CompletedOne Study Center