Effects of Ginseng on Stress, Emotional and Cognitive Processing

NCT06414486 | Completed

• 1 other identifier: GINZEN
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress

Keywords

Panax ginseng; Stress; Fatigue; Emotion processing

Outcome Measures

Primary Outcomes (1)

• A decrease of stress level

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

  3 weeks

Secondary Outcomes (8)

• Evolution of depression state

  3 weeks

• Evolution of anxiety state

  3 weeks

• Evolution of emotional processing

  3 weeks

• Evolution of fatigue level

  3 weeks

• Evolution of attentional performance

  3 weeks

Study Arms (2)

Dietary supplement group

EXPERIMENTAL

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

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

Other: Placebo group

Interventions

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).

Dietary supplement group

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).

Control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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, ...).

Sponsors & Collaborators

• Botalys: lead
• Université Catholique de Louvain: collaborator

Study Sites (1)

Center of Investigation in Clinical Nutrition (CICN)

Louvain-la-Neuve, 1348, Belgium

Location

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Louise Deldicque, Prof

  Université Catholique de Louvain

  STUDY DIRECTOR

• Sylvie Copine, Dr

  Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: May 10, 2024
• First Posted: May 16, 2024
• Study Start: May 12, 2023
• Primary Completion: December 7, 2023
• Study Completion: April 30, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)