Clinical trial NCT04848948: Impact of Calory Restriction and Biofeedback on Endocrine and Mental Health
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuroendocrinology
Mental Stress
Psychological
Obesity
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2021-04-19
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: PSS score
timeFrame: Baseline, changes over two weeks
measure: BODI
timeFrame: Baseline, changes over two weeks
measure: BSI
timeFrame: Baseline, changes over two weeks
measure: waist-to-height ratio
timeFrame: Baseline
measure: HbA1c
timeFrame: Baseline
measure: HOMA-IR
timeFrame: Baseline
measure: Matsuda Index
timeFrame: Baseline
measure: Body mass index
timeFrame: Baseline, changes over two weeks
measure: HRV
timeFrame: Baseline, changes over two weeks
Secondary outcomes:
measure: Body fat
timeFrame: Baseline, changes over two weeks
measure: lean mass
timeFrame: Baseline, changes over two weeks
measure: Phase angle
timeFrame: Baseline, changes over two weeks
measure: Resistin
timeFrame: Baseline, changes over two weeks
measure: Leptin
timeFrame: Baseline, changes over two weeks
measure: Secretagogin
timeFrame: Baseline, changes over two weeks
measure: Adiponectin
timeFrame: Baseline, changes over two weeks
measure: BDNF
timeFrame: Baseline, changes over two weeks
measure: Estrogen
timeFrame: Baseline, changes over two weeks
measure: Testosterone
timeFrame: Baseline, changes over two weeks
measure: Luteinizing hormone
timeFrame: Baseline, changes over two weeks
measure: Follicle-stimulating hormone
timeFrame: Baseline, changes over two weeks
measure: Total cholesterol
timeFrame: Baseline, changes over two weeks
measure: High-density lipoprotein (HDL)
timeFrame: Baseline, changes over two weeks
measure: BSRI
timeFrame: Baseline
Other outcomes:
Locations:
city: Gars am Kamp
country: Austria
facility: VAMED Gender Insitute
state: Niederösterreich
Study officials:
References: