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Completed

NCT Number: NCT04848948

Impact of Calory Restriction and Biofeedback on Endocrine and Mental Health

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

VAMED Gender Insitute

Gars am Kamp, Lower Austria, 3571, Austria

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Calory Restriction (F.X. Mayr & VLCD)

Behavioral

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

Behavioral

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.

Primary outcomes

  1. PSS score

    Time frame: Baseline, changes over two weeks

    Perceived Stress Scale total score

  2. BODI

    Time frame: Baseline, changes over two weeks

    buron-out-diagnostic-inventory scores, 4 summary items and 3 stress self-ratings

  3. BSI

    Time frame: Baseline, changes over two weeks

    Brief Symptom Inventory, 9 dimensional subscores and global severity score

  4. waist-to-height ratio

    Time frame: Baseline

    Anthropometric parameter

  5. HbA1c

    Time frame: Baseline

    Glycated hemoglobin

  6. HOMA-IR

    Time frame: Baseline

    Functional parameter for insulin resistance

  7. Matsuda Index

    Time frame: Baseline

    Functional parameter for insulin sensitivity

  8. Body mass index

    Time frame: Baseline, changes over two weeks

    weight in relation to height

  9. HRV

    Time frame: Baseline, changes over two weeks

    heart rate variability

Secondary outcomes

  1. Body fat

    Time frame: Baseline, changes over two weeks

    measured by bioimpedance analysis

  2. lean mass

    Time frame: Baseline, changes over two weeks

    measured by bioimpedance analysis

  3. Phase angle

    Time frame: Baseline, changes over two weeks

    ratio of reactance versus electric resistance, measured by bioimpedance analysis

  4. Resistin

    Time frame: Baseline, changes over two weeks

    Adipocines

  5. Leptin

    Time frame: Baseline, changes over two weeks

    Adipocines

  6. Secretagogin

    Time frame: Baseline, changes over two weeks

    Adipocines

  7. Adiponectin

    Time frame: Baseline, changes over two weeks

    Adipocines

  8. BDNF

    Time frame: Baseline, changes over two weeks

    brain derived neurotrophic factor

  9. Estrogen

    Time frame: Baseline, changes over two weeks

    Sex hormone

  10. Testosterone

    Time frame: Baseline, changes over two weeks

    Sex hormone

  11. Luteinizing hormone

    Time frame: Baseline, changes over two weeks

    Sex hormone

  12. Follicle-stimulating hormone

    Time frame: Baseline, changes over two weeks

    Sex hormone

  13. Total cholesterol

    Time frame: Baseline, changes over two weeks

    Lipid metabolism

  14. High-density lipoprotein (HDL)

    Time frame: Baseline, changes over two weeks

    Lipid metabolism

  15. BSRI

    Time frame: Baseline

    Bem sex role inventory, female, male, neutral scores

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 19, 2021
Registry last updated
Apr 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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