NCT04848948

Impact of Calory Restriction and Biofeedback on Endocrine and Mental Health

Completed NA Last updated 19 April 2021

What this trial tests

NA trial testing Calory Restriction (F.X. Mayr & VLCD) in Neuroendocrinology in 44 participants. Completed in 4 March 2020.

Timeline

1 September 2019

Primary endpoint
4 March 2020

4 March 2020

Quick facts

Lead sponsor	Medical University of Vienna
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	44
Start date	1 September 2019
Primary completion	4 March 2020
Estimated completion	4 March 2020
Sites	1 location across Austria

Drugs / interventions tested

• Calory Restriction (F.X. Mayr & VLCD)
• Biofeedback

Conditions studied

• Neuroendocrinology — all drugs for Neuroendocrinology →
• Mental Stress — all drugs for Mental Stress →
• Psychological — all drugs for Psychological →
• Obesity — all drugs for Obesity →

Sponsor

Medical University of Vienna

Who can join

18 and older, female only, with Neuroendocrinology or Mental Stress. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The Effects of Caloric Restriction and Clinical Psychological Intervention on the Interplay of Gut Microbial Composition and Stress in Women.
   Bellach L, Kautzky-Willer A, Heneis K, Leutner M, et al · · 2024 · cited 2× · PMID 39203721 · DOI 10.3390/nu16162584