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临床试验/NCT04848948
NCT04848948已完成不适用

Effects of Short-term Calory Restriction and Biofeedback on Anthropometric and Metabolic Parameters as Well as Biological and Psychological Stress Correlates in Healthy Women

Medical University of Vienna2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2019年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
44
试验地点
2
主要终点
PSS score

研究概览

简要总结

Backgroup/relevance: Overweight and obesity, defined by a respective body mass index of above 25 and 30 kg/m2, are getting increasingly common in all regions of the world. Obesity is currently estimated to be present in more than 10% of the global population while overweight roughly reached an estimate of 40% in 2016.

Overweight dramatically increases the risk for a wide range of disorders such as diabetes mellitus and other metabolic and cardiovascular disorders subsumed under the term metabolic syndrome, increasing the risk for life-threatening cardiovascular events such as myocardial infarction and stroke. Similar to other chronic diseases such as mental health disorders, prescribing medication was oftentimes insufficient and should be complemented by patient empowerment to reach sufficient treatment adherence and control of lifestyle factors. Thereby, overweight and obesity can easily be challenged by patients themselves without pharmacological intervention.

Overweight may place central in the crossroad between metabolic and mental health for several reasons. Excessive body fat is known to cause subclinical inflammation that was also associated with many psychiatric disorders such as major depression. Similarly, the hypothalamic-pituitary-adrenal axis relevant for stress response was shown to be dysregulated in both metabolic and mental health disorders.

Study design: In this study, non-pharmacological interventions are applied in healthy women with overweight or obesity and self-perceived psychological stress. Women staying at the "la pura" women´s health resort (www.lapura.at/) are invited to partake in the study and receive a short-term intervention of calory restriction. Thereby, either F.X. Mayr or very-low-calory-diet (VLCD) will be applied, reducing calory intake to 700-800 kcal/die. Following random assigment to four treatment arms, half of the women also receive a 7-session clinical-psychological intervention consisting of biofeedback, individualized psycho-education on stress prevention and mindlessness training.

Women are assessed at baseline and after two weeks of interventions for metabolic parameters such as insulin functioning, anthropometric parameters such as body weight and body fat, blood parameters such as sex hormones, fat metabolism and liver function, parameters of neuroplasticity such as brain derived neurotrophic factor (BDNF), as well as psychological and biological stress correlates and mental health symptom dimensions.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • women willing to undergo two-weeks of calory restriction
  • at least 18 years of age

排除标准

  • currently pregnant
  • any acute or a severe chronic illness

结局指标

主要结局

PSS score

时间窗: Baseline, changes over two weeks

Perceived Stress Scale total score

BSI

时间窗: Baseline, changes over two weeks

Brief Symptom Inventory, 9 dimensional subscores and global severity score

Matsuda Index

时间窗: Baseline

Functional parameter for insulin sensitivity

HRV

时间窗: Baseline, changes over two weeks

heart rate variability

HbA1c

时间窗: Baseline

Glycated hemoglobin

HOMA-IR

时间窗: Baseline

Functional parameter for insulin resistance

Body mass index

时间窗: Baseline, changes over two weeks

weight in relation to height

BODI

时间窗: Baseline, changes over two weeks

buron-out-diagnostic-inventory scores, 4 summary items and 3 stress self-ratings

waist-to-height ratio

时间窗: Baseline

Anthropometric parameter

次要结局

  • Resistin(Baseline, changes over two weeks)
  • Follicle-stimulating hormone(Baseline, changes over two weeks)
  • Total cholesterol(Baseline, changes over two weeks)
  • Secretagogin(Baseline, changes over two weeks)
  • Adiponectin(Baseline, changes over two weeks)
  • Phase angle(Baseline, changes over two weeks)
  • BDNF(Baseline, changes over two weeks)
  • Luteinizing hormone(Baseline, changes over two weeks)
  • BSRI(Baseline)
  • lean mass(Baseline, changes over two weeks)
  • Body fat(Baseline, changes over two weeks)
  • Leptin(Baseline, changes over two weeks)
  • Estrogen(Baseline, changes over two weeks)
  • Testosterone(Baseline, changes over two weeks)
  • High-density lipoprotein (HDL)(Baseline, changes over two weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alexandra Kautzky-Willer

Prof.Dr.

Medical University of Vienna

研究点 (2)

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