Clinical trial NCT01672359: Evaluating Whole Foods Supplementation on Cognition
Official title: The Effect of Whole-Food Dietary Supplementation on Cognitive and Immune Functioning and Quality of Life in Healthy Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sub-optimal Cognitive Function
Sub-optimal Immune Function
Keywords: cognitive functioning
immune function
cytokines
growth factors
quality of life
dietary supplementation
Ginkgo biloba
Improvement of cognitive function
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Standard Process Inc.
First posted: 2012-08-24
Enrollment: 97
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility 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

Primary outcomes:
measure: Cognitive Measures
timeFrame: 6 months
Secondary outcomes:
measure: Quality of Life Measures
timeFrame: 6 months
measure: Immune Function Markers
timeFrame: 6 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: Clinical Research Building
state: Florida
Study officials:
affiliation: University of Miami
name: John Lewis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lewis JE, Melillo AB, Tiozzo E, Chen L, Leonard S, Howell M, Diaz J, Gonzalez K, Woolger JM, Konefal J, Paterson E, Barnes D. A double-blind, randomized clinical trial of dietary supplementation on cognitive and immune functioning in healthy older adults. BMC Complement Altern Med. 2014 Feb 4;14:43. doi: 10.1186/1472-6882-14-43.