Evaluating Whole Foods Supplementation on Cognition

NCT01672359 | Completed

• 1 other identifier: 20090985
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (1)

• Cognitive Measures

  The measures included the MMSE, the Stroop Color and Word Test (SCWT), the Trail Making Test Parts A and B (TMT-A, TMT-B), the Controlled Oral Word Association test (COWA), the Digit Symbol subtest of the Wechsler Adult Intelligence Scale, Third Edition (WAIS-III), and the Hopkins Verbal Learning Test-Revised (HVLT-R)

  6 months

Secondary Outcomes (2)

• Quality of Life Measures

  6 months

• Immune Function Markers

  6 months

Study Arms (3)

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)

Dietary Supplement: Ginkgo Synergy® and Choline

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)

Dietary Supplement: OPC Synergy® and Catalyn

Placebo

PLACEBO COMPARATOR

cellulose pills to simulate actual products

Dietary Supplement: Placebo

Interventions

Ginkgo Synergy® and Choline DIETARY_SUPPLEMENT

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

Ginkgo Synergy® and Choline

OPC Synergy® and Catalyn DIETARY_SUPPLEMENT

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

OPC Synergy® and Catalyn

Placebo DIETARY_SUPPLEMENT

Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

Sponsors & Collaborators

• University of Miami: lead
• Standard Process Inc.: collaborator

Study Sites (1)

Clinical Research Building

Miami, Florida, 33136, United States

Location

Related Publications (1)

• 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.

  PMID: 24495355 DERIVED

MeSH Terms

Interventions

Choline

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Onium Compounds

Study Officials

• John Lewis, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 20, 2012
• First Posted: August 24, 2012
• Study Start: May 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: August 6, 2014

Record last verified: 2014-08

Locations

US (1)