StressGNIZENNCT06414486
Effects of Ginseng on Stress, Emotional and Cognitive Processing
A study testing Dietary supplement group in people with Stress, run by Botalys at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Dietary supplement group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteBelgium
- Study dates
- 12 May 2023to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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, ...).
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Center of Investigation in Clinical Nutrition (CICN)
Louvain-la-Neuve, 1348
About this study
Official title: 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.
Read the 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.
- Conditions
- Stress
- Being tested
- Dietary supplement group, Placebo group
- Keywords
- Panax ginseng, Stress, Fatigue, Emotion processing
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary supplement groupDietary supplement
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 groupOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Dietary supplement group | Experimental | Participants received orally 1 tablet containing 200mg of Red Panax Ginseng for 4 weeks Receives: Dietary Supplement: Dietary supplement group |
| Control group | Placebo comparator | Participants received orally 1 tablet similar to the test product, containing no active principle for 3 weeks Receives: Other: Placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
A decrease of stress level
Comparison between groups of the adjusted for baseline stress level assessed by the Perceived Stress Scale (PSS)
Measured: 3 weeks
Secondary outcomes (8)
Evolution of depression state
Comparison between groups of the adjusted for baseline of depression state (BDI)
Measured: 3 weeks
Evolution of anxiety state
Comparison between groups of the adjusted for baseline of anxiety state (STAI-S)
Measured: 3 weeks
Evolution of emotional processing
Comparison between groups of the adjusted for baseline of emotional processing assessed by the PANAS
Measured: 3 weeks
Evolution of fatigue level
Comparison between groups of the adjusted for baseline of fatigue level (PIC)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start12 May 2023
- Primary completion7 Dec 2023
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparative, randomized, placebo-controlled, double-blind, monocentric interventional study in parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Botalys
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Université Catholique de Louvain
- Responsible party
- Sponsor
- Investigators
- Louise Deldicque, Prof, Study director, Université Catholique de LouvainSylvie Copine, Dr, Principal investigator, Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06414486
- Sponsor's protocol ID
- GINZEN
- Acronym
- GNIZEN
- Status last verified
- May 2024
- First submitted
- 10 May 2024
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Botalys Red Panax Ginseng on Cognitive, Psychological and Emotional Processing in Stressed Adults
- ClinicalTrials.gov ID
- NCT06414486
- Acronym / sponsor ID
- GNIZEN / GINZEN
- Conditions
- Stress
- Keywords
- Panax ginseng, Stress, Fatigue, Emotion processing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- BotalysIndustry (pharma, biotech, devices)
- Collaborators
- Université Catholique de Louvain
- Study start
- 12 May 2023 (actual)
- Primary completion
- 7 Dec 2023 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Comparative, randomized, placebo-controlled, double-blind, monocentric interventional study in parallel groups
| Arm | Type | Receives |
|---|---|---|
| Dietary supplement group | Experimental | Dietary Supplement: Dietary supplement groupParticipants received orally 1 tablet containing 200mg of Red Panax Ginseng for 4 weeks |
| Control group | Placebo comparator | Other: Placebo groupParticipants received orally 1 tablet similar to the test product, containing no active principle for 3 weeks |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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, ...).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary supplement groupOne 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). | Dietary supplement | Dietary supplement group |
| Placebo groupOne 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). | Other | Control group |
Primary outcome
A decrease of stress level
Time frame: 3 weeks
Comparison between groups of the adjusted for baseline stress level assessed by the Perceived Stress Scale (PSS)
8 secondary outcomes
Evolution of depression state
Time frame: 3 weeks
Evolution of anxiety state
Time frame: 3 weeks
Evolution of emotional processing
Time frame: 3 weeks
Evolution of fatigue level
Time frame: 3 weeks
Evolution of attentional performance
Time frame: 3 weeks
Evolution of memory performance
Time frame: 3 weeks
Evolution of executive functions performance
Time frame: 3 weeks
The intervention satisfaction of the volunteer
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louise Deldicque, Prof study director
Université Catholique de Louvain
Sylvie Copine, Dr principal investigator
Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary supplement group in people with Stress, run by Botalys at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A decrease of stress level (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.