## Protocol Section
### Identification Module
**NCT ID:** NCT06414486

**Acronym:** GNIZEN

**Brief Title:** 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

#### Organization Study ID Info
**ID:** GINZEN
#### Organization
**Class:** INDUSTRY
**Full Name:** Botalys
### Status Module
#### Completion Date
**Date:** 2024-04-30

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-10

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-12-07

**Type:** ACTUAL

#### Start Date
**Date:** 2023-05-12

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-10
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Université Catholique de Louvain

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Botalys

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Stress

**Keywords:**

- Panax ginseng

- Stress

- Fatigue

- Emotion processing

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Comparative, randomized, placebo-controlled, double-blind, monocentric interventional study in parallel groups

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 150

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants received orally 1 tablet containing 200mg of Red Panax Ginseng for 4 weeks

**Intervention Names:**

- Dietary Supplement: Dietary supplement group

**Label:** Dietary supplement group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Participants received orally 1 tablet similar to the test product, containing no active principle for 3 weeks

**Intervention Names:**

- Other: Placebo group

**Label:** Control group

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Dietary supplement group

**Description:** 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).

**Name:** Dietary supplement group

**Type:** DIETARY_SUPPLEMENT

#### Intervention 2

**Arm Group Labels:**

- Control group

**Description:** 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).

**Name:** Placebo group

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Comparison between groups of the adjusted for baseline stress level assessed by the Perceived Stress Scale (PSS)

**Measure:** A decrease of stress level

**Time Frame:** 3 weeks

#### Secondary Outcomes

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

**Measure:** Evolution of depression state

**Time Frame:** 3 weeks

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

**Measure:** Evolution of anxiety state

**Time Frame:** 3 weeks

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

**Measure:** Evolution of emotional processing

**Time Frame:** 3 weeks

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

**Measure:** Evolution of fatigue level

**Time Frame:** 3 weeks

**Description:** Comparison between groups of the adjusted for baseline of attentional performance assessed by the Reaction Time and Rapid Visual Information Processing subtests of CANTAB.

**Measure:** Evolution of attentional performance

**Time Frame:** 3 weeks

**Description:** 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.

**Measure:** Evolution of memory performance

**Time Frame:** 3 weeks

**Description:** 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.

**Measure:** Evolution of executive functions performance

**Time Frame:** 3 weeks

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

**Measure:** The intervention satisfaction of the volunteer

**Time Frame:** 3 weeks

### Eligibility Module

**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, ...).

**Healthy Volunteers:** True

**Maximum Age:** 60 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Louvain-la-Neuve

**Country:** Belgium

**Facility:** Center of Investigation in Clinical Nutrition (CICN)

**Zip:** 1348

#### Overall Officials

**Official 1:**

**Affiliation:** Université Catholique de Louvain

**Name:** Louise Deldicque, Prof

**Role:** STUDY_DIRECTOR

**Official 2:**

**Affiliation:** Université Catholique de Louvain

**Name:** Sylvie Copine, Dr

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M8364

- Name: Fatigue

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Browse Branches

- Abbrev: HB

- Name: Herbal and Botanical

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: T168

- Name: Ginseng

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
