Impact of Calory Restriction and Biofeedback on Endocrine and Mental Health

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04848948
• Other study ID #: 2020-GI-01
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Mental Stress
• Neuroendocrinology
• Obesity
• Psychological
• Stress, Psychological

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