Ginseng and Ginkgo Biloba Effects on Cognition as Modulated by Cardiovascular Reactivity

There is some evidence to suggest that ginseng and Ginkgo biloba can improve cognitive performance, however, very little is known about the mechanisms associated with such improvement. Here, we tested whether cardiovascular reactivity to a task is associated with cognitive improvement.

Study Overview

• Status: Completed
• Conditions: Blood Pressure; Cognition
• Intervention / Treatment: Drug: Placebo; Drug: Ginseng; Drug: Ginkgo Biloba

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Malaysia
  • Selangor
    • Bandar Sunway, Selangor, Malaysia, 47500
      • Department of Psychology, Sunway University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy volunteers ranging in age between 18 and 30.

Exclusion Criteria:

• Ginseng group: exclude those that regularly consume caffeine or Panax Ginseng, or those that are diabetic, have hormone sensitive conditions, autoimmune diseases, bleeding conditions, heart conditions or take medications that are known to interact with Panax Ginseng. These include anticoagulants, Warfarin, Ibuprofen, MAOIs, medications that are changed by the liver, and stimulant drugs (e.g. pseudoephedrine, epinephrine).
• Ginkgo Biloba group: exclude those that regularly consume caffeine or Ginkgo Biloba, or those that are diabetic, have experienced seizures in the past, have bleeding disorders, or take medications that are known to interact with Ginkgo Biloba. These include Ibuprofen, anticoagulants, Warfarin, Buspirone, Fluoxetine, Trazodone

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Placebo; Study subjects received, in a double blind fashion, placebo pills identical to the drug (ginseng: group 1; ginkgo biloba: group 2).	Drug: Placebo; Study subjects received, in a double blind fashion, placebo pills identical to the drug (drug 1-ginseng, group 1; drug 2-ginkgo biloba-group 2); Drug: Ginseng; The ginseng group received two capsules containing either 1000 mg or 500 mg of Panax Ginseng extract standardized to 3% of ginsenosides (GNC, USA) or similarly looking placebo capsules over a period of three days of testing.; Drug: Ginkgo Biloba; The ginkgo group received two capsules containing either 240 mg or 120 mg of ginkgo biloba extract standardized to 24% ginkgo flavone glycosides and 6% terpene lactones (GBE24/6) or similarly looking placebo capsules over a period of three testing days.
Experimental: Ginseng; Participants in the ginseng group received a medium, and higher dose of ginseng in addition to placebo capsules.	Drug: Placebo; Study subjects received, in a double blind fashion, placebo pills identical to the drug (drug 1-ginseng, group 1; drug 2-ginkgo biloba-group 2); Drug: Ginseng; The ginseng group received two capsules containing either 1000 mg or 500 mg of Panax Ginseng extract standardized to 3% of ginsenosides (GNC, USA) or similarly looking placebo capsules over a period of three days of testing.
Experimental: Ginkgo Biloba; Participants in the ginkgo biloba group received a medium, and higher dose of ginkgo in addition to placebo capsules.	Drug: Placebo; Study subjects received, in a double blind fashion, placebo pills identical to the drug (drug 1-ginseng, group 1; drug 2-ginkgo biloba-group 2); Drug: Ginkgo Biloba; The ginkgo group received two capsules containing either 240 mg or 120 mg of ginkgo biloba extract standardized to 24% ginkgo flavone glycosides and 6% terpene lactones (GBE24/6) or similarly looking placebo capsules over a period of three testing days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive performance as modulated by either ginseng or ginkgo biloba	Cognitive effects on tests of vigilance/attention, behavioural flexibility and executive functioning	Acute effects (3 days of testing)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular reactivity as a result of ginseng or ginkgo biloba intake	Changes in systolic, diastolic and heart rate reading as a result of ginseng or ginkgo biloba intake and dependent upon the type of cognitive domain assessed (i.e. vigilance, behavioural flexibility or executive functioning.	Acute effects (3 days of testing)

Collaborators and Investigators

• Sponsor: Sunway University
• Investigators: Principal Investigator: Luca Aquili, PhD, Sunway University

Publications and helpful links

General Publications

• Ong Lai Teik D, Lee XS, Lim CJ, Low CM, Muslima M, Aquili L. Ginseng and Ginkgo Biloba Effects on Cognition as Modulated by Cardiovascular Reactivity: A Randomised Trial. PLoS One. 2016 Mar 3;11(3):e0150447. doi: 10.1371/journal.pone.0150447. eCollection 2016.

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: March 6, 2015
• First Submitted That Met QC Criteria: March 6, 2015
• First Posted (Estimate): March 12, 2015

Study Record Updates

• Last Update Posted (Estimate): March 13, 2015
• Last Update Submitted That Met QC Criteria: March 11, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: cognition; Ginseng; Ginkgo Biloba; cardiovascular reactivity
• Other Study ID Numbers: Sunway-979