Effects of Ginseng on Stress, Emotional and Cognitive Processing (GNIZEN)

Evaluation of the Effects of Botalys Red Panax Ginseng on Cognitive, Psychological and Emotional Processing in Stressed Adults

This study aims to confirm the positive effect of the Red Panax Ginseng on the cognitive performance and regulation of stress and fatigue in adults with moderate stress level.

Study Overview

• Status: Completed
• Conditions: Stress
• Intervention / Treatment: Dietary supplement: Dietary supplement group; Other: Placebo group

Detailed Description

This study has been designed as a randomized double-blind placebo-controlled interventional study.

One hundred and fifty participants (aged between 18 and 60), presenting a moderate level of perceived stress, were randomly allocated to the control (placebo) or test (ginseng supplement) group. Participants will be supplemented during 3 weeks with those products. Cognitive performance and emotional processing will be measured with tests and questionnaires before (baseline) and at the end (3 weeks) of the intervention. Fasted blood glucose level will be measured in blood before (baseline) and at the end (3 weeks) of the intervention.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Louvain-la-Neuve, Belgium, 1348
    • Center of Investigation in Clinical Nutrition (CICN)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

I.1. Healthy woman or man, aged of 18 to 60 years (inclusive); I.2. With a moderate level of perceived stress (PSS scores ranging from 14 to 26); I.3. Provision of signed and dated informed consent form; I.4. Stated willingness to comply with all study procedures and availability for the duration of the study; I.5. Speaking French.

Exclusion Criteria:

E.1. Subject with severe medical or cognitive problems which, in the opinion of the Principal Investigator, could interfere with the evaluation of the study criteria or with participant safety; E.2. Subject with a coffee consumption of more than 5 cups per day; E.3. Subject consuming drugs and/or with historical drug addiction (<5 years); E.4. Subject with alcohol consumption exceeding 3 glasses of wine per day, or two halves of a beer per day, or one glass of strong alcohol per day; E.5. Subject undergoing medical treatment which, in the opinion of the Principal Investigator, could interfere with cognitive and emotional processing; E.6. Subject with type 1 or type 2 diabetes; E.7. Subject participating in another intervention trial; E.8. Women of childbearing age who are pregnant or breastfeeding or who wish to become pregnant within the next 6 weeks or who are not using an adequate method of contraception (e.g. oral contraception, IUD, abstinence, ...).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dietary supplement group; Participants received orally 1 tablet containing 200mg of Red Panax Ginseng for 4 weeks	Dietary supplement: Dietary supplement group; One tablet per day for 3 weeks consumed for subjects randomized in the Dietary supplementation group. This will lead to an intake of 200mg per day of Red Panax Ginseng (corresponding to 22.4mg of ginsenosides and 20.2mg of rare ginsenosides).
Placebo Comparator: Control group; Participants received orally 1 tablet similar to the test product, containing no active principle for 3 weeks	Other: Placebo group; One tablet per day consumed for 3 weeks for subjects randomized in the Control group. The product is composed of rice flour (50mg) and brown sugar (150mg).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A decrease of stress level	Comparison between groups of the adjusted for baseline stress level assessed by the Perceived Stress Scale (PSS)	3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evolution of depression state	Comparison between groups of the adjusted for baseline of depression state (BDI)	3 weeks
Evolution of anxiety state	Comparison between groups of the adjusted for baseline of anxiety state (STAI-S)	3 weeks
Evolution of emotional processing	Comparison between groups of the adjusted for baseline of emotional processing assessed by the PANAS	3 weeks
Evolution of fatigue level	Comparison between groups of the adjusted for baseline of fatigue level (PIC)	3 weeks
Evolution of attentional performance	Comparison between groups of the adjusted for baseline of attentional performance assessed by the Reaction Time and Rapid Visual Information Processing subtests of CANTAB.	3 weeks
Evolution of memory performance	Comparison between groups of the adjusted for baseline of memory performance assessed by the Verbal Recognition Memory, Paired Associate Learning and Spatial Span subtests of CANTAB.	3 weeks
Evolution of executive functions performance	Comparison between groups of the adjusted for baseline of executive functions performance assessed by the Multitasking Test and One Touch Stockings of Cambridge subtests of CANTAB.	3 weeks
The intervention satisfaction of the volunteer	Comparison between groups of the adjusted for baseline of the intervention satisfaction of the volunteer, evaluated by a Likert scale	3 weeks

Collaborators and Investigators

• Sponsor: Botalys
• Collaborators: Université Catholique de Louvain
• Investigators: Principal Investigator: Sylvie Copine, Dr, Université Catholique de Louvain; Study Director: Louise Deldicque, Prof, Université Catholique de Louvain

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2023
• Primary Completion (Actual): December 7, 2023
• Study Completion (Actual): April 30, 2024

Study Registration Dates

• First Submitted: May 10, 2024
• First Submitted That Met QC Criteria: May 10, 2024
• First Posted (Actual): May 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 10, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Stress; Fatigue; Panax ginseng; Emotion processing
• Other Study ID Numbers: GINZEN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No