Impact of Calory Restriction and Biofeedback on Endocrine and Mental Health

Effects of Short-term Calory Restriction and Biofeedback on Anthropometric and Metabolic Parameters as Well as Biological and Psychological Stress Correlates in Healthy Women

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Psychological; Mental Stress; Neuroendocrinology
• Intervention / Treatment: Behavioral: Calory Restriction (F.X. Mayr & VLCD); Behavioral: Biofeedback

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Niederösterreich
    • Gars am Kamp, Niederösterreich, Austria, 3571
      • VAMED Gender Insitute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: F.X.Mayr & Biofeedback; two weeks of F.X. Mayr diet and biofeedback	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.; Behavioral: 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.
Active Comparator: F.X.Mayr; two weeks of F.X. Mayr diet	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.
Experimental: VLCD & Biofeedback; two weeks of very low calorie diet and biofeedback	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.; Behavioral: 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.
Active Comparator: VLCD; two weeks of very low calorie diet	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Medical University of Vienna

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Actual): March 4, 2020
• Study Completion (Actual): March 4, 2020

Study Registration Dates

• First Submitted: April 9, 2021
• First Submitted That Met QC Criteria: April 13, 2021
• First Posted (Actual): April 19, 2021

Study Record Updates

• Last Update Posted (Actual): April 19, 2021
• Last Update Submitted That Met QC Criteria: April 13, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological
• Other Study ID Numbers: 2020-GI-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Upon request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No