Stress
Conditions
Keywords
Panax ginseng, Stress, Fatigue, Emotion processing
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.
Interventions
DIETARY_SUPPLEMENTDietary 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).
OTHERPlacebo 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).
Sponsors
Université Catholique de Louvain
Botalys
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Comparative, randomized, placebo-controlled, double-blind, monocentric interventional study in parallel groups
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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, ...).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| A decrease of stress level | 3 weeks | Comparison between groups of the adjusted for baseline stress level assessed by the Perceived Stress Scale (PSS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evolution of anxiety state | 3 weeks | Comparison between groups of the adjusted for baseline of anxiety state (STAI-S) |
| Evolution of emotional processing | 3 weeks | Comparison between groups of the adjusted for baseline of emotional processing assessed by the PANAS |
| Evolution of fatigue level | 3 weeks | Comparison between groups of the adjusted for baseline of fatigue level (PIC) |
| Evolution of depression state | 3 weeks | Comparison between groups of the adjusted for baseline of depression state (BDI) |
| Evolution of memory performance | 3 weeks | 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. |
| Evolution of executive functions performance | 3 weeks | 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. |
| The intervention satisfaction of the volunteer | 3 weeks | Comparison between groups of the adjusted for baseline of the intervention satisfaction of the volunteer, evaluated by a Likert scale |
| Evolution of attentional performance | 3 weeks | Comparison between groups of the adjusted for baseline of attentional performance assessed by the Reaction Time and Rapid Visual Information Processing subtests of CANTAB. |
Countries
Belgium
Outcome results
None listed