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Effects of Ginseng on Stress, Emotional and Cognitive Processing (GNIZEN)

B

Botalys

Status

Completed

Conditions

Stress

Treatments

Dietary Supplement: Dietary supplement group
Other: Placebo group

Study type

Interventional

Funder types

Other
Industry

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

150 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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, ...).

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

150 participants in 2 patient groups, including a placebo group

Dietary supplement group
Experimental group
Description:
Participants received orally 1 tablet containing 200mg of Red Panax Ginseng for 4 weeks
Treatment:
Dietary Supplement: Dietary supplement group
Control group
Placebo Comparator group
Description:
Participants received orally 1 tablet similar to the test product, containing no active principle for 3 weeks
Treatment:
Other: Placebo group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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