跳至主要内容
临床试验/NCT02997137
NCT02997137已完成3 期

Impact of a Specific Amino Acid Composition With Micronutrients on Wellbeing and Endocrine-cardiometabolic Situation of Patients With Chronic Exhaustion Conditions, Such as Burnout

Doris Meister1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2014年10月1日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
74
试验地点
1
主要终点
Perceived Stress Questionnaire (PSQ30)

研究概览

简要总结

Chronic psychological distress can lead to chronic exhaustion conditions, such as burnout. These conditions are associated with a deficiency of specific amino acids and micronutrients that cause endocrine-cardiometabolic abnormalities. These people have specific medically-determined nutrient requirements.

Aim of this study is to demonstrate, that the daily oral administration of a specific amino acid composition (dosage 4.2 g/day) with micronutrients (e. g. 7 vitamins of the B-complex, magnesium, zinc) designed to decrease chronic exhaustion conditions will significantly decrease the perceived chronic distress and associated chronic exhaustion conditions of women and men after 8 and 12 weeks.

详细描述

Chronic psychological distress can lead to chronic exhaustion conditions, such as burnout. This clinical condition is characterized by reduced satisfaction in performance, exhaustion and depersonalization. Individuals under prolonged exposure to chronic work-life stress and insufficient recovery are at high risk for developing burnout symptoms. Social services, caregiving and teaching professions with a perceived imbalance of effort and reward are often affected. Until now, a general accepted definition of burnout syndrome and its binding diagnostic criteria have not been established. Moreover, there is a strong association between chronic psychological distress and somatoform symptoms, like sleeping disturbances, headaches and abdominal pain that cannot be fully explained by medical or neurological condition. Physiologically the hypothalamus pituitary adrenal axis (HPA-axis) is the central system for the long term adaptation of an organism to stress. During stress exposure, the HPA-axis is activated and the adrenal cortex produces high levels of cortisol with a stress inhibitory function at the same time. However, exposure to long-term chronic stress is associated with biological dysregulation and can result in hypofunctioning of the HPA-axis and a state of hypocortisolism. In addition, the serotonergic system, the immune system and the amino acid metabolism get adversely affected.

Stress-related eating behaviours frequently results in an imbalance of amino acids and deficiency of micronutrients (i. e. B-vitamins and magnesium) that cause endocrine-cardiometabolic abnormalities. Intake of specific amino acids can affect the brain functioning and mental health. Some amino acids are precursors of the neurotransmitters in the brain. Moreover, l-ornithine and taurine are suggested to have an antifatigue effect. Dietary intake of B-vitamins and magnesium, the important stress-mineral, had positive effects on mood and perceived stress.

Aim of this study is to demonstrate, that the daily oral administration of a specific amino acid composition (dosage 4.2 g/day) with micronutrients (e. g. 7 vitamins of the B-complex, magnesium, zinc) designed to decrease chronic exhaustion conditions will significantly decrease the perceived chronic distress and associated chronic exhaustion conditions of women and men after 8 and 12 weeks.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age: 18-65 years
  • •Perceived Stress Questionnaire 30 (PSQ30): total score > 0.50

排除标准

  • •Age: < 18 and > 65 Years
  • •Perceived Stress Questionnaire (PSQ30): total score ≤ 0.50
  • •Supplementation or therapy with dietary supplements or drugs which contains amino acids (e. g. l-tryptophan), vitamins and other micronutrients (have to discontinue 4 weeks prior to the start of the study)
  • •Therapy with antidepressant drugs such as monoamine oxidase inhibitors
  • •Hypertension (untreated > 150/90 mmHg, treated > 140/85 mmHg)
  • •Organic fatigue
  • •Phenylketonuria
  • •Acute and chronic diarrhea

研究组 & 干预措施

BOT-01

Active Comparator

Dietary supplement: specific amino acid composition with micronutrients

干预措施: BOT-01 (Dietary Supplement)

Placebo

Placebo Comparator

Placebo contains no amino acids and no micronutrients and is identical in appearance and solution properties

干预措施: Placebo (Other)

结局指标

主要结局

Perceived Stress Questionnaire (PSQ30)

时间窗: 8-week dietary intervention

Intervention changes in the total PSQ30 score at baseline and after 8 weeks

Perceived Stress Questionnaire (PSQ30)

时间窗: 12-week dietary intervention

Intervention changes in the total PSQ30 score at baseline and after 12 weeks

次要结局

  • Salivary cortisol concentration in the evening (between 10 and 11 pm, at least 30 minutes after dinner) and in the morning (30 minutes after waking in the morning)(12-week dietary intervention)
  • The Visual Analog Scale (VAS)(8-week dietary intervention)
  • The Visual Analog Scale (VAS)(12-week dietary intervention)

研究者

发起方
Doris Meister
申办方类型
Industry
责任方
Sponsor Investigator
主要研究者

Doris Meister

Doris Meister, Sponsor-Investigator

Kyberg Vital GmbH

研究点 (1)

Loading locations...

相似试验