Impact of Calory Restriction and Biofeedback on Endocrine and Mental Health

Not Applicable

Completed

• Conditions: Obesity; Mental Stress; Neuroendocrinology; Psychological
• Interventions: Behavioral: Calory Restriction (F.X. Mayr & VLCD); Behavioral: Biofeedback

• Registration Number: NCT04848948
• Lead Sponsor: Medical University of Vienna

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-01
• Primary Completion: 2020-03-04
• Study Completion: 2020-03-04
• Status Verified: 2021-04
• Study First Submitted: 2021-04-09
• Study First Submitted QC: 2021-04-13
• Last Update Submitted: 2021-04-13
• Study First Posted: 2021-04-19
• Last Update Posted: 2021-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 44

Inclusion Criteria

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

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Exclusion Criteria

• currently pregnant
• any acute or a severe chronic illness

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VLCD & Biofeedback	Calory Restriction (F.X. Mayr & VLCD)	two weeks of very low calorie diet and biofeedback
F.X.Mayr & Biofeedback	Biofeedback	two weeks of F.X. Mayr diet and biofeedback
F.X.Mayr & Biofeedback	Calory Restriction (F.X. Mayr & VLCD)	two weeks of F.X. Mayr diet and biofeedback
F.X.Mayr	Calory Restriction (F.X. Mayr & VLCD)	two weeks of F.X. Mayr diet
VLCD & Biofeedback	Biofeedback	two weeks of very low calorie diet and biofeedback
VLCD	Calory Restriction (F.X. Mayr & VLCD)	two weeks of very low calorie diet

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

VAMED Gender Insitute; 🇦🇹 Gars am Kamp, Niederösterreich, Austria