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Completed

NCT Number: NCT06414486

Effects of Ginseng on Stress, Emotional and Cognitive Processing

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center of Investigation in Clinical Nutrition (CICN)

Louvain-la-Neuve, 1348, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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, ...).

Treatment and study plan

Dietary supplement Group

Dietary 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 Group

Other

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).

Primary outcomes

  1. 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)

Secondary outcomes

  1. Evolution of depression state

    Time frame: 3 weeks

    Comparison between groups of the adjusted for baseline of depression state (BDI)

  2. Evolution of anxiety state

    Time frame: 3 weeks

    Comparison between groups of the adjusted for baseline of anxiety state (STAI-S)

  3. Evolution of emotional processing

    Time frame: 3 weeks

    Comparison between groups of the adjusted for baseline of emotional processing assessed by the PANAS

  4. Evolution of fatigue level

    Time frame: 3 weeks

    Comparison between groups of the adjusted for baseline of fatigue level (PIC)

  5. Evolution of attentional performance

    Time frame: 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.

  6. Evolution of memory performance

    Time frame: 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.

  7. Evolution of executive functions performance

    Time frame: 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.

  8. The intervention satisfaction of the volunteer

    Time frame: 3 weeks

    Comparison between groups of the adjusted for baseline of the intervention satisfaction of the volunteer, evaluated by a Likert scale

Sponsors and collaborators

Lead sponsor

Botalys

Industry

Collaborators

  • Université Catholique de Louvain

Registry information

Official study title

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

Acronym: GNIZEN

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
May 16, 2024
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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