Effects of Ginseng on Stress, Emotional and Cognitive Processing

Stress Clinical Trial

— GNIZEN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06414486
• Other study ID #: GINZEN
• Status: Completed
• Phase: N/A
• Start date: May 12, 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: May 2024
• Source: Botalys
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: April 30, 2024
• Est. primary completion date: December 7, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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, ...).

Related Conditions & MeSH terms

• Stress

Intervention

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).

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).

Locations

Country	Name	City	State
Belgium	Center of Investigation in Clinical Nutrition (CICN)	Louvain-la-Neuve

Sponsors (2)

Lead Sponsor	Collaborator
Botalys	Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evolution of depression state	Comparison between groups of the adjusted for baseline of depression state (BDI)	3 weeks
Secondary	Evolution of anxiety state	Comparison between groups of the adjusted for baseline of anxiety state (STAI-S)	3 weeks
Secondary	Evolution of emotional processing	Comparison between groups of the adjusted for baseline of emotional processing assessed by the PANAS	3 weeks
Secondary	Evolution of fatigue level	Comparison between groups of the adjusted for baseline of fatigue level (PIC)	3 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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