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Impact of Calory Restriction and Biofeedback on Endocrine and Mental Health

Primary Purpose

Neuroendocrinology, Mental Stress, Psychological

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Calory Restriction (F.X. Mayr & VLCD)
Biofeedback
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Neuroendocrinology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • VAMED Gender Insitute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

F.X.Mayr & Biofeedback

F.X.Mayr

VLCD & Biofeedback

VLCD

Arm Description

two weeks of F.X. Mayr diet and biofeedback

two weeks of F.X. Mayr diet

two weeks of very low calorie diet and biofeedback

two weeks of very low calorie diet

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 9, 2021
Last Updated
April 13, 2021
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT04848948
Brief Title
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

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
March 4, 2020 (Actual)
Study Completion Date
March 4, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroendocrinology, Mental Stress, Psychological, Obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
F.X.Mayr & Biofeedback
Arm Type
Experimental
Arm Description
two weeks of F.X. Mayr diet and biofeedback
Arm Title
F.X.Mayr
Arm Type
Active Comparator
Arm Description
two weeks of F.X. Mayr diet
Arm Title
VLCD & Biofeedback
Arm Type
Experimental
Arm Description
two weeks of very low calorie diet and biofeedback
Arm Title
VLCD
Arm Type
Active Comparator
Arm Description
two weeks of very low calorie diet
Intervention Type
Behavioral
Intervention Name(s)
Calory Restriction (F.X. Mayr & VLCD)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Biofeedback
Intervention Description
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 Outcome Measure Information:
Title
PSS score
Description
Perceived Stress Scale total score
Time Frame
Baseline, changes over two weeks
Title
BODI
Description
buron-out-diagnostic-inventory scores, 4 summary items and 3 stress self-ratings
Time Frame
Baseline, changes over two weeks
Title
BSI
Description
Brief Symptom Inventory, 9 dimensional subscores and global severity score
Time Frame
Baseline, changes over two weeks
Title
waist-to-height ratio
Description
Anthropometric parameter
Time Frame
Baseline
Title
HbA1c
Description
Glycated hemoglobin
Time Frame
Baseline
Title
HOMA-IR
Description
Functional parameter for insulin resistance
Time Frame
Baseline
Title
Matsuda Index
Description
Functional parameter for insulin sensitivity
Time Frame
Baseline
Title
Body mass index
Description
weight in relation to height
Time Frame
Baseline, changes over two weeks
Title
HRV
Description
heart rate variability
Time Frame
Baseline, changes over two weeks
Secondary Outcome Measure Information:
Title
Body fat
Description
measured by bioimpedance analysis
Time Frame
Baseline, changes over two weeks
Title
lean mass
Description
measured by bioimpedance analysis
Time Frame
Baseline, changes over two weeks
Title
Phase angle
Description
ratio of reactance versus electric resistance, measured by bioimpedance analysis
Time Frame
Baseline, changes over two weeks
Title
Resistin
Description
Adipocines
Time Frame
Baseline, changes over two weeks
Title
Leptin
Description
Adipocines
Time Frame
Baseline, changes over two weeks
Title
Secretagogin
Description
Adipocines
Time Frame
Baseline, changes over two weeks
Title
Adiponectin
Description
Adipocines
Time Frame
Baseline, changes over two weeks
Title
BDNF
Description
brain derived neurotrophic factor
Time Frame
Baseline, changes over two weeks
Title
Estrogen
Description
Sex hormone
Time Frame
Baseline, changes over two weeks
Title
Testosterone
Description
Sex hormone
Time Frame
Baseline, changes over two weeks
Title
Luteinizing hormone
Description
Sex hormone
Time Frame
Baseline, changes over two weeks
Title
Follicle-stimulating hormone
Description
Sex hormone
Time Frame
Baseline, changes over two weeks
Title
Total cholesterol
Description
Lipid metabolism
Time Frame
Baseline, changes over two weeks
Title
High-density lipoprotein (HDL)
Description
Lipid metabolism
Time Frame
Baseline, changes over two weeks
Title
BSRI
Description
Bem sex role inventory, female, male, neutral scores
Time Frame
Baseline

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
VAMED Gender Insitute
City
Gars am Kamp
State/Province
Niederösterreich
ZIP/Postal Code
3571
Country
Austria

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Upon request

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Impact of Calory Restriction and Biofeedback on Endocrine and Mental Health

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