Impact of Calory Restriction and Biofeedback on Endocrine and Mental Health

Study Overview
=================
Brief Summary
-----------------
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.

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

Conditions
-----------------
Neuroendocrinology, Mental Stress, Psychological, Obesity

Intervention / Treatment
-----------------
* Behavioral: Calory Restriction (F.X. Mayr & VLCD)
* Behavioral: Biofeedback


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women willing to undergo two-weeks of calory restriction at least 18 years of age Exclusion Criteria: currently pregnant any acute or a severe chronic illness

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: F.X.Mayr & Biofeedback<br>two weeks of F.X. Mayr diet and biofeedback | Behavioral: Calory Restriction (F.X. Mayr & VLCD)<br>* VLCD restricts calory intake to 630 - 700 kcal per day (20% fat, 34% protein, 46% carbohydrates). F.X. Mayr diet similarly applies calorie restriction to 700 - 800 kcal per day and includes daily ingestion of isotonic magnesium sulfate solution.<br>Behavioral: Biofeedback<br>* Three sessions of biofeedback (50 minutes) over a time frame of 14 days, aimed at improving biological functions and especially heart-rate-variability under stress condition.<br>|
| Active Comparator: F.X.Mayr<br>two weeks of F.X. Mayr diet | Behavioral: Calory Restriction (F.X. Mayr & VLCD)<br>* VLCD restricts calory intake to 630 - 700 kcal per day (20% fat, 34% protein, 46% carbohydrates). F.X. Mayr diet similarly applies calorie restriction to 700 - 800 kcal per day and includes daily ingestion of isotonic magnesium sulfate solution.<br>|
| Experimental: VLCD & Biofeedback<br>two weeks of very low calorie diet and biofeedback | Behavioral: Calory Restriction (F.X. Mayr & VLCD)<br>* VLCD restricts calory intake to 630 - 700 kcal per day (20% fat, 34% protein, 46% carbohydrates). F.X. Mayr diet similarly applies calorie restriction to 700 - 800 kcal per day and includes daily ingestion of isotonic magnesium sulfate solution.<br>Behavioral: Biofeedback<br>* Three sessions of biofeedback (50 minutes) over a time frame of 14 days, aimed at improving biological functions and especially heart-rate-variability under stress condition.<br>|
| Active Comparator: VLCD<br>two weeks of very low calorie diet | Behavioral: Calory Restriction (F.X. Mayr & VLCD)<br>* VLCD restricts calory intake to 630 - 700 kcal per day (20% fat, 34% protein, 46% carbohydrates). F.X. Mayr diet similarly applies calorie restriction to 700 - 800 kcal per day and includes daily ingestion of isotonic magnesium sulfate solution.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PSS score | Perceived Stress Scale total score | Baseline, changes over two weeks | 
| BODI | buron-out-diagnostic-inventory scores, 4 summary items and 3 stress self-ratings | Baseline, changes over two weeks | 
| BSI | Brief Symptom Inventory, 9 dimensional subscores and global severity score | Baseline, changes over two weeks | 
| waist-to-height ratio | Anthropometric parameter | Baseline | 
| HbA1c | Glycated hemoglobin | Baseline | 
| HOMA-IR | Functional parameter for insulin resistance | Baseline | 
| Matsuda Index | Functional parameter for insulin sensitivity | Baseline | 
| Body mass index | weight in relation to height | Baseline, changes over two weeks | 
| HRV | heart rate variability | Baseline, changes over two weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body fat | measured by bioimpedance analysis | Baseline, changes over two weeks | 
| lean mass | measured by bioimpedance analysis | Baseline, changes over two weeks | 
| Phase angle | ratio of reactance versus electric resistance, measured by bioimpedance analysis | Baseline, changes over two weeks | 
| Resistin | Adipocines | Baseline, changes over two weeks | 
| Leptin | Adipocines | Baseline, changes over two weeks | 
| Secretagogin | Adipocines | Baseline, changes over two weeks | 
| Adiponectin | Adipocines | Baseline, changes over two weeks | 
| BDNF | brain derived neurotrophic factor | Baseline, changes over two weeks | 
| Estrogen | Sex hormone | Baseline, changes over two weeks | 
| Testosterone | Sex hormone | Baseline, changes over two weeks | 
| Luteinizing hormone | Sex hormone | Baseline, changes over two weeks | 
| Follicle-stimulating hormone | Sex hormone | Baseline, changes over two weeks | 
| Total cholesterol | Lipid metabolism | Baseline, changes over two weeks | 
| High-density lipoprotein (HDL) | Lipid metabolism | Baseline, changes over two weeks | 
| BSRI | Bem sex role inventory, female, male, neutral scores | Baseline |