Clinical trial NCT06414486: Effects of Ginseng on Stress, Emotional and Cognitive Processing
Official title: Evaluation of the Effects of Botalys Red Panax Ginseng on Cognitive, Psychological and Emotional Processing in Stressed Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Keywords: Panax ginseng
Stress
Fatigue
Emotion processing
Lead sponsor: Botalys
Sponsor class: INDUSTRY
Collaborators: name: Université Catholique de Louvain
First posted: 2024-05-16
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparative, randomized, placebo-controlled, double-blind, monocentric interventional study in parallel groups
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: 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, ...).

Primary outcomes:
measure: A decrease of stress level
timeFrame: 3 weeks
Secondary outcomes:
measure: Evolution of depression state
timeFrame: 3 weeks
measure: Evolution of anxiety state
timeFrame: 3 weeks
measure: Evolution of emotional processing
timeFrame: 3 weeks
measure: Evolution of fatigue level
timeFrame: 3 weeks
measure: Evolution of attentional performance
timeFrame: 3 weeks
measure: Evolution of memory performance
timeFrame: 3 weeks
measure: Evolution of executive functions performance
timeFrame: 3 weeks
measure: The intervention satisfaction of the volunteer
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Louvain-la-Neuve
country: Belgium
facility: Center of Investigation in Clinical Nutrition (CICN)
Study officials:
affiliation: Université Catholique de Louvain
name: Louise Deldicque, Prof
role: STUDY_DIRECTOR
affiliation: Université Catholique de Louvain
name: Sylvie Copine, Dr
role: PRINCIPAL_INVESTIGATOR
References: