A Specialized Nutraceutical for Pre-burnout

NCT04532892 | Completed

• 1 other identifier: 2019-A02049-48
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Burnout; Dietary Supplement; Anxiety; Stress; Plants

Outcome Measures

Primary Outcomes (1)

• Mean score of the validated MQLI questionnaire (Multicultural Quality of Life Index)

  A self-administered questionnaire. Score from 0 to 10 (from very bad Quality of Life to very good Quality of Life).

  0 day (baseline), 60 days, 120 days

Secondary Outcomes (7)

• Hospital Anxiety and depression questionnaire

  0 day (baseline) and 120 days

• Cungi questionnaire

  0 day (baseline) and 120 days

• Cohen questionnaire

  0 day (baseline) and 120 days

• MBI questionnaire (Maslach Burn Out Inventory Questionnaire)

  0 day (baseline) and 120 days

• PSQI Questionnaire (PITTSBURG SLEEP QUALITY INDEX)

  0 day (baseline) and 120 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Morning and night tablets with no active ingrédients. Morning and night tablets are different.

Dietary Supplement: Placebo Meta 18.06 Day and Placebo Meta 18.06 Night

Dietary supplément

EXPERIMENTAL

Morning and night tablets with active ingrédients. Morning and night tablets are different.

Dietary Supplement: Meta 18.06 Day and Meta 18.06 Night

Interventions

Meta 18.06 Day and Meta 18.06 Night DIETARY_SUPPLEMENT

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 supplément

Placebo Meta 18.06 Day and Placebo Meta 18.06 Night DIETARY_SUPPLEMENT

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)

Placebo

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female or male aged between 30 and 65 years (limits included),
• Presenting symptoms of stress, work or emotional overload based on :

You may not qualify if:

• Suffering from depression based on the Hospital anxiety and depression scale (depression score over 14),
• Considered in burn-out, based on MBI questionnaire:
• Burnout \> 30
• Depersonalization \> 12
• Personnal achievement \< 33 2 conditions should be fulfilling to exclude participant.
• Under nutritional supplement or drugs (psychotropics, betablockers) acting on mental health according to the investigator or stopped less than 3 months before the study.
• Diagnose of burn-out for less than 2y.

Sponsors & Collaborators

• Institut Pasteur de Lille: lead

Study Sites (1)

NutrInvest - Institut Pasteur de Lille

Lille, Nord, 59019, France

Location

MeSH Terms

Conditions

Burnout, Psychological; Anxiety Disorders

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: During the whole study, neither the investigators nor the subjects will be aware of the product they test. Every effort will be made to maintain the blind during the study.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD in nutrition and endocrinology

Model Details: Monocentric, double-blind, randomized, placebo-controlled, 2-parallel arm study on outpatients

Study Record Dates

• First Submitted: July 9, 2020
• First Posted: August 31, 2020
• Study Start: March 3, 2020
• Primary Completion: November 25, 2022
• Study Completion: November 25, 2022
• Last Updated: December 8, 2022

Record last verified: 2022-12

Locations

FR (1)