Effects of Short-term Calory Restriction and Biofeedback on Anthropometric and Metabolic Parameters as Well as Biological and Psychological Stress Correlates in Healthy Women
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
- 是
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
Alexandra Kautzky-Willer
Prof.Dr.
Medical University of Vienna
