MedTrace Logo

A Specialized Nutraceutical for Pre-burnout

NCT04532892 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-12-08

No results posted yet for this study

Summary

High demands, professional overload and emotional stress are well known negative influences on mental health. Chronic stress-related occupational diseases, especially Burnout, are becoming an important issue. Burnout can be defined as a negative affective state consisting of emotional exhaustion, cognitive weariness and physical fatigue, which is caused by chronic psychosocial stress.

Currently, there is no standard treatment for Burnout but different forms of psychological interventions are usually attempted. Also the administration of anxiolytics, antidepressants and sedatives only targets symptoms with a risk of addiction.

Recently, adaptogen plants have shown promising effects (e.g. Siberian Ginseng, Panax Ginseng, Rhodiola rosea and Ashwagandha) by increasing the body's ability to resist stress and exert a balancing effect on various systems of the body.

This study is focused on the effect of a specialized nutraceutical, containing adaptogen plants (Ashwagandha, Rhodiole rosea, Ginseng) as well as Vitamins and minerals (e.g. Vitamin C) needed for a normal hypothalamus-pituitary-adrenal (HPA) axis regulation in subjects suffering of early Burnout symptoms (pré-Burnout).

Conditions

  • Burn Out
  • Psychological Disturbance

Interventions

DIETARY_SUPPLEMENT

Meta 18.06 Day and Meta 18.06 Night

5 visits after screening (V0-V4), including questionnaires (V0-V2-V4), salivary tests (V0 \& V4) and calls for antistress advices and adverse events, concomitant medication reporting \& compliance (V1 \& V3)

DIETARY_SUPPLEMENT

Placebo Meta 18.06 Day and Placebo Meta 18.06 Night

5 visits after screening (V0-V4), including questionnaires (V0-V2-V4), salivary tests (V0 \& V4) and calls for antistress advices and adverse events, concomitant medication reporting \& compliance (V1 \& V3)

Sponsors & Collaborators

  • Institut Pasteur de Lille

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-03-03
Primary Completion
2022-11-25
Completion
2022-11-25

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04532892 on ClinicalTrials.gov