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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04848948
Other study ID # 2020-GI-01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2019
Est. completion date March 4, 2020

Study information

Verified date April 2021
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date March 4, 2020
Est. primary completion date March 4, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Behavioral:
Calory Restriction (F.X. Mayr & VLCD)
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.
Biofeedback
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.

Locations

Country Name City State
Austria VAMED Gender Insitute Gars am Kamp Niederösterreich

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary PSS score Perceived Stress Scale total score Baseline, changes over two weeks
Primary BODI buron-out-diagnostic-inventory scores, 4 summary items and 3 stress self-ratings Baseline, changes over two weeks
Primary BSI Brief Symptom Inventory, 9 dimensional subscores and global severity score Baseline, changes over two weeks
Primary waist-to-height ratio Anthropometric parameter Baseline
Primary HbA1c Glycated hemoglobin Baseline
Primary HOMA-IR Functional parameter for insulin resistance Baseline
Primary Matsuda Index Functional parameter for insulin sensitivity Baseline
Primary Body mass index weight in relation to height Baseline, changes over two weeks
Primary HRV heart rate variability Baseline, changes over two weeks
Secondary Body fat measured by bioimpedance analysis Baseline, changes over two weeks
Secondary lean mass measured by bioimpedance analysis Baseline, changes over two weeks
Secondary Phase angle ratio of reactance versus electric resistance, measured by bioimpedance analysis Baseline, changes over two weeks
Secondary Resistin Adipocines Baseline, changes over two weeks
Secondary Leptin Adipocines Baseline, changes over two weeks
Secondary Secretagogin Adipocines Baseline, changes over two weeks
Secondary Adiponectin Adipocines Baseline, changes over two weeks
Secondary BDNF brain derived neurotrophic factor Baseline, changes over two weeks
Secondary Estrogen Sex hormone Baseline, changes over two weeks
Secondary Testosterone Sex hormone Baseline, changes over two weeks
Secondary Luteinizing hormone Sex hormone Baseline, changes over two weeks
Secondary Follicle-stimulating hormone Sex hormone Baseline, changes over two weeks
Secondary Total cholesterol Lipid metabolism Baseline, changes over two weeks
Secondary High-density lipoprotein (HDL) Lipid metabolism Baseline, changes over two weeks
Secondary BSRI Bem sex role inventory, female, male, neutral scores Baseline
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