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临床试验/NCT01425983
NCT01425983已完成3 期

Dietary Intervention of Stress-Induced Neurovegetative Disorders in Men and Women With a Specific Amino Acid Composition With Micronutrients

Kyberg Vital GmbH2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2011年3月1日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
80
试验地点
2
主要终点
Psychological neurological questionnaire (PNF)

研究概览

简要总结

Psychosocial stress leads to altered neuroendocrine functions, such as serotonergic dysfunction, as well as alterations of the autonomic nervous system and the hypothalamic-pituitary-adrenal (HPA) axis activity resulting in an imbalance between inhibitory and excitatory neurotransmitters. Clinical consequences include, inter alia, neurovegetative disorders, higher resting heart rate, hypertension, depressive symptoms, sleep disturbances, irregular body-weight changes, and insulin resistance. Poor dietary intake of the essential amino acid L-tryptophane as a precursor to 5-hydroxytryptamine (HT, serotonin) increases sensitivity to stress.

It is therefore the investigators hypothesis that daily oral administration of an amino acid mixture (dosage 3.8 g/day) with micronutrients specifically designed to decrease neurovegetative disorders will target these neuroendocrine and metabolic alterations in adults with psychosocial stress. The principal endpoints will be a decrease in points in the psychological-neurological questionnaire (PNF).

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

入选标准

  • Age: 18-65 Years
  • Psychological-Neurological Questionnaire (PNF): 30 - 50 Points

排除标准

  • Age: < 18 and > 65 Years
  • Psychological neurological questionnaire (PNF): < 30 and > 50 Points
  • Resting heart rate: < 70/min
  • Supplementation with dietary supplements or drugs which contains amino acids, vitamins and other micronutrients
  • Therapy with antipsychotic drugs such as tranquilizer, antidepressants
  • acute and chronic diarrhea
  • Psychological-neurological or psychiatric therapy

结局指标

主要结局

Psychological neurological questionnaire (PNF)

时间窗: 12-week dietary intervention

Pre-post intervention changes in total number of points PNF

次要结局

  • Psychological neurological questionnaire (PNF)(12-week dietary intervention)
  • Salivary cortisol concentration (30 minutes after waking in the morning)(12-week dietary intervention)
  • Salivary cortisol concentration (in the evening between 8 and 10 pm, 2 hours after dinner)(12-week dietary intervention)
  • Serotonin concentration in blood(12-week dietary intervention)

研究者

发起方
Kyberg Vital GmbH
申办方类型
Industry
责任方
Principal Investigator
主要研究者

Doris Meister

Doris Meister, Sponsor-Investigator

Kyberg Vital GmbH

研究点 (2)

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