A double-blind, randomized clinical trial of dietary supplementation on cognitive and immune functioning in healthy older adults.
BACKGROUND
Declining cognitive function is relatively common and increasingly prevalent. Studies have shown that different nutrients (e.g., Ginkgo biloba and vitamin E) appear to be effective at improving memory and concentration, while less is known about their effect on immunity.


METHODS
This study investigated the effect of Ginkgo Synergy(®) plus Choline (n = 33) and OPC Synergy(®) plus Catalyn(®) (n = 31) versus placebo (n = 33) in a 6-month, randomized, double-blind trial on cognitive and immune functioning among English-speaking, non-smoking, healthy older adults. The Stroop Color and Word Test, Trail Making Test A and B, Controlled Oral Word Association, Hopkins Verbal Learning, Mini-Mental State Exam, and Digit Symbol were administered at baseline and 3 and 6 months follow-up to assess cognitive functioning. Cytokines and growth factors were measured at baseline and 6 months to assess inflammation and immune functioning. Data were analyzed with linear mixed modeling.


RESULTS
No serious adverse events were noted in this study. According to time on the Trail Making Test-B, the Ginkgo Synergy(®) plus Choline arm showed improvement from baseline to 3 months follow-up (mean difference = 24.2; SE = 6.4; 95% CI: 8.6, 39.7; p = 0.01). On the Controlled Oral Word Association Trial-S, the scores significantly increased for the Ginkgo Synergy(®) plus Choline arm from baseline to 6 months follow-up (mean difference = 2.1; SE = 0.8; 95% CI: 0.2, 3.9; p < 0.05) and for the OPC Synergy(®) plus Catalyn(®) arm from baseline to 3 months follow-up (mean difference = 2.1; SE = 0.8; 95% CI: 0.2, 4.0; p < 0.05). Epidermal growth factor significantly decreased from baseline to 6 months follow-up for the Ginkgo Synergy(®) plus Choline arm (mean difference = 120.7; SE = 28.4; 95% CI: 62.6, 178.8; p < 0.001).


CONCLUSIONS
Our study showed isolated and modest effects of a Ginkgo biloba plus choline-based formula on cognitive and immune functioning among healthy older adults with no history of significant cognitive deficits. Our trial was registered with clinicaltrials.gov (ID: NCT01672359). This study was supported by a grant from Standard Process, Inc.
Department of Psychiatry & Behavioral Sciences, University of Miami Miller School of Medicine, 1120 NW 14th Street, Miami, FL 33136, USA. jelewis@miami.edu.
John E
JE
Lewis
Angelica B
AB
Melillo
Eduard
E
Tiozzo
Lawrence
L
Chen
Susanna
S
Leonard
Mark
M
Howell
Janelle
J
Diaz
Kathy
K
Gonzalez
Judi M
JM
Woolger
Janet
J
Konefal
Elaine
E
Paterson
David
D
Barnes
D000368:Aged; D000369:Aged, 80 and over; D002794:Choline / Q000494:pharmacology / Q000627:therapeutic use; D003071:Cognition / Q000187:drug effects*; D019587:Dietary Supplements; D004311:Double-Blind Method; D004815:Epidermal Growth Factor / Q000378:metabolism; D005260:Female; D020441:Ginkgo biloba; D006801:Humans; D007109:Immunity / Q000187:drug effects*; D008297:Male; D008568:Memory / Q000187:drug effects*; D008875:Middle Aged; D008517:Phytotherapy; D010936:Plant Extracts / Q000494:pharmacology* / Q000627:therapeutic use; D012016:Reference Values
D010936:Plant Extracts; D004815:Epidermal Growth Factor; D002794:Choline