Efficacy and Tolerance of a Specialized Nutraceutical for Pre-burnout - a Randomized, Double Blind Placebo Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Mean score of the validated MQLI questionnaire (Multicultural Quality of Life Index)
研究概览
简要总结
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).
详细描述
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 is an outcome of chronic depletion of the individual's coping resources resulting from prolonged exposure to stress, particularly work-related stress. In Germany, 8% of the working population believe they suffer from burnout syndrome. Among 7400 Czech Physicians, 34% feel they show symptoms and 83% perceive themselves at risk for having a burnout. Currently, the prevention of burnout has been discussed worldwide as absenteeism and other negative consequences related to job satisfaction, work performance and patient care lead to an economic burden.
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. The 3 major dimensions of Burnout are emotional exhaustion, depersonalizations (cynicism) and a decreased sense of personal accomplishment or inefficacy. It is characterized by fatigue, mood disorder, sleep problems and cognitive impairment but is difficult to differentiate from depression as both illnesses are often related. The main difference with depression is at physiological level, mainly in Cortisol and dehydroepiandrosterone-sulphate (DHEA) levels.
Increased psychological stress affects the hypothalamus-pituitary-adrenal (HPA) axis regulation. During acute stress, plasma cortisol levels rise but during chronic stress, cortisol levels decline leading to a state of depletion. This depletion leads to a smaller increase of cortisol shortly after waking up, also known as the cortisol awakening response, leading to a disruption of the circadian rhythm, fatigue and a decreased mental performance. Next to cortisol, also DHEA levels are lower, especially in young Burnout patients. DHEA is an active hormone with effects on its own and a precursor of androgens and estrogens. It has a regenerative and protective role important for maintenance and restoration of health, thus very important in Burnout.
Next to hormones, also nutritional deficiencies related to HPA axis dysfunction could play a role in the development of Burnout. Vitamin C for example is needed for steroid biosynthesis, Niacin derivates are cofactors and Pantothenic acid and folic acid are vital to maintain steroid secretion from the adrenal cortex. Adrenocortical insufficiency has also been noted during biotin deficiency.
Diagnosis of Burnout often occurs via psychological scales (e.g. Maslach Burnout Inventory) with high scores for exhaustion and cynicism and low scores for professional efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 30 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Female or male aged between 30 and 65 years (limits included),
- •Presenting symptoms of stress, work or emotional overload based on :
- •COHEN questionnaire (score ≥ 21 allowed the inclusion),
- •CUNGI questionnaire (part 1: score ≥ 18 allowed the inclusion; part 2: score ≥ 30 allowed the inclusion).
排除标准
- •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.
结局指标
主要结局
Mean score of the validated MQLI questionnaire (Multicultural Quality of Life Index)
时间窗: 0 day (baseline), 60 days, 120 days
A self-administered questionnaire. Score from 0 to 10 (from very bad Quality of Life to very good Quality of Life).
次要结局
- 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)
- Saliva Cortisol(0 day (baseline) and 120 days)
- 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)
- SF-36 questionnaire(0 day (baseline) and 120 days)
研究者
Jean-Michel Lecerf
MD in nutrition and endocrinology
Institut Pasteur de Lille
