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Research on Prevention, Intervention and Mechanisms of Obesity and Its Comorbidities (Obesity)

Primary Purpose

Obesity, Exercise, Nutrition, Healthy

Status
Recruiting
Phase
Not Applicable
Locations
Slovakia
Study Type
Interventional
Intervention
Complex lifestyle intervention
Carnosine
Sponsored by
Slovak Academy of Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Obesity

Eligibility Criteria

25 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • sedentary men and women (approximately 1:1) aged 25-45 years, BMI 28-38 kg/m2
  • absence of chronic diseases and regular pharmacotherapy intake
  • capable to complete a training intervention (assessment by a cardiologist)
  • signed informed consent
  • absence of any psychological, sociological or geographical factors that could jeopardize participation in the study
  • Vaccination against SARS-CoV-2 with one of the approved vaccines available in Slovakia (at least 2 weeks after the last dose) and regular PCR testing during the study.

Exclusion Criteria:

  • any chronic disease (oncological, cardiovascular, neurological, liver, kidney or other diseases and its acute complications at the discretion of the doctor);
  • No cooperation of probands;
  • insufficient functional capacity - the presence comorbidities or disorders of the musculoskeletal system, which makes it impossible to complete the training program (assessment by cardiologist, or orthopedist or other specialist);
  • smoking, alcohol or drugs abuse;
  • non-compliance with epidemiological measures;
  • absence of complete vaccination with SARS-CoV-2 vaccine;
  • presence of a pacemaker or metal implants (contraindication for magnetic resonance imaging).

Sites / Locations

  • Biomedical Research Center Slovak Academy of SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Complex Intervention with Carnosine

Complex Intervention with placebo

Without complex intervention with carnosine

Without complex intervention with placebo

Arm Description

Obese middle aged individuals will be subjected to 3 month complex lifestyle intervention including exercise (3 times per week) nutritional (weekly consultation) and psychological (monthly) interventions combined with oral administration of carnosine in dose 2g per day.

Obese middle aged individuals will be subjected to 3 month complex lifestyle intervention including exercise (3 times per week) nutritional (weekly consultation) and psychological (monthly) interventions combined with oral administration of identically looking placebo.

Obese middle aged individuals will be subjected to standard clinical procedure without lifestyle interventions. Oral administration of carnosine in dose 2g per day will be provided.

Obese middle aged individuals will be subjected to standard clinical procedure without lifestyle interventions. Oral administration of identically looking placebo will be provided.

Outcomes

Primary Outcome Measures

Intervention induced change in abdominal adiposity
Body fat composition will be measured by bioelectrical impedance analysis and presented in percentage.
Intervention induced change in VO2max.
Maximal aerobic capacity will be measured by testing physical performance on a bicycle ergometer. Results will be presented as mL/(kg·min) units.
Intervention induced change in abdominal muscle mass
Changes in the abdominal muscle mass will be measured by Magnetic resonance imaging (MRI).
Intervention induced change in muscle strength.
Muscle strength will be measured by handheld dynamometer.
Intervention induced change in glucose level and glucose metabolism.
Fasting glucose level measurement and glucose tolerance test will be provided for volunteers.
Intervention induces change in lipid profile.
Measurement of total cholesterol, HDL, LDL, VLDL and triglycerides will be performed from the blood samples.

Secondary Outcome Measures

Full Information

First Posted
November 2, 2021
Last Updated
January 14, 2022
Sponsor
Slovak Academy of Sciences
Collaborators
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT05211817
Brief Title
Research on Prevention, Intervention and Mechanisms of Obesity and Its Comorbidities
Acronym
Obesity
Official Title
Physical Activity and Nutrition Program in the Prevention and Treatment of Obesity, Mechanisms of Obesity and Its Comorbidities
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Slovak Academy of Sciences
Collaborators
Medical University of Vienna

4. Oversight

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

5. Study Description

Brief Summary
Obesity and lack of physical activity are associated with an increased risk of many chronic diseases and accelerate the processes associated with aging. Weight reduction and physical fitness are health benefits of long-term and comprehensive lifestyle modification based on nutritional habits, increased physical activity and psychotherapy. A healthy lifestyle is the basis for the prevention and treatment of obesity. However, conditions for the prescription of physical activity, nutrition and psychotherapy have not been established in our healthcare system. The aim of the project is to determine the effects of a 3-month complex intervention with/without carnosine (including aerobic/strength training, nutritional and psychological counseling) on body composition, physical fitness and circulating biochemical characteristics. Molecular biomarkers can be a very useful diagnostic markers as well as a parameter for monitoring the effectiveness of a complex lifestyle intervention. Long-term follow-up and inclusion in long-term programs will be offered to all study probands who are interested.
Detailed Description
Training is combining one 60min session of aerobic training with two 1-hour weekly lessons of aerobic strength training composed of 25 minutes, 60-70% 1RM, training the large muscle groups and 25 minutes of rowing or stationary biking. Starting with warm-up and stretching cool down at the end. The individualized training program will be based on the actual patients physical fitness (VO2max, bicycle spiroergometry) and muscle strength (dynamometry). The training will take place in small groups of 4-5 volunteers. There will be 15-minute breaks for ventilation and surface disinfection between training sessions. All coaches of the Center are vaccinated. The aim is to provide a safe environment for training, in order to increase physical fitness and reduce the weight of obese patients. The center has experience with full-time and online trainings (via the publicly available Facebook BMC SAS as well as through the ZOOM platform) http://www.biomedcentrum.sav.sk/centrum-pohybovej-aktivity/ The nutritional intervention will be carried out by nutrition specialists with the use of individual and group counseling, which enables the individualized dietary prescription. Coaching will take place in person in groups of 5-10 probands (BMC SAS, with a frequency of once a month, in accordance with the current epidemiological situation), resp. by phone / online, with a frequency of once a week. Psychological counseling will be provided by clinical psychologists. Individual and group form, with a frequency of at least once per month. Psychological counseling will focus on identifying the triggers of inappropriate eating behavior and influencing them, as well as supporting the development of new, healthier habits. 3 months carnosine supplementation (2 g per day) will be provided as described elsewhere.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Exercise, Nutrition, Healthy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised controlled trial with complex lifestyle intervention and carnosine supplementation.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Block randomisation for carnosine, identically looking control and intervention treatment
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Complex Intervention with Carnosine
Arm Type
Experimental
Arm Description
Obese middle aged individuals will be subjected to 3 month complex lifestyle intervention including exercise (3 times per week) nutritional (weekly consultation) and psychological (monthly) interventions combined with oral administration of carnosine in dose 2g per day.
Arm Title
Complex Intervention with placebo
Arm Type
Experimental
Arm Description
Obese middle aged individuals will be subjected to 3 month complex lifestyle intervention including exercise (3 times per week) nutritional (weekly consultation) and psychological (monthly) interventions combined with oral administration of identically looking placebo.
Arm Title
Without complex intervention with carnosine
Arm Type
Experimental
Arm Description
Obese middle aged individuals will be subjected to standard clinical procedure without lifestyle interventions. Oral administration of carnosine in dose 2g per day will be provided.
Arm Title
Without complex intervention with placebo
Arm Type
No Intervention
Arm Description
Obese middle aged individuals will be subjected to standard clinical procedure without lifestyle interventions. Oral administration of identically looking placebo will be provided.
Intervention Type
Behavioral
Intervention Name(s)
Complex lifestyle intervention
Intervention Description
Volunteers will undergo a 3-month comprehensive lifestyle modification, consisting of a combined aerobic-strength training intervention, nutritional and psychological counseling. Regular examinations (body weight, waist circumference, body composition by bioimpedance) will be performed every week. Probands in the intervention and control groups will have the opportunity to participate in a long-term program of physical activity at BMC SAS after the end of the study.
Intervention Type
Dietary Supplement
Intervention Name(s)
Carnosine
Intervention Description
3 months carnosine supplementation (2 g per day) will be given in parallel with a complex lifestyle modification. Carnosine is a dipeptide of beta-alanyl l-histidine, which is found in skeletal muscle and in certain areas of the brain. It is a well-tolerated and approved food supplement in Slovakia. Scientists have extensive experience with the administration of carnosine (deCourten, Ukropcová et al, Obesity 2015 https://doi.org/10.1002/oby.21434; Schon, Ukropcova et al, 2019 DOI: 10.3390 / nu11061196 and others). Carnosine has the potential to positively affect glucose metabolism, and improve the adaptive response to exercise training interventions.
Primary Outcome Measure Information:
Title
Intervention induced change in abdominal adiposity
Description
Body fat composition will be measured by bioelectrical impedance analysis and presented in percentage.
Time Frame
3 months
Title
Intervention induced change in VO2max.
Description
Maximal aerobic capacity will be measured by testing physical performance on a bicycle ergometer. Results will be presented as mL/(kg·min) units.
Time Frame
3 months
Title
Intervention induced change in abdominal muscle mass
Description
Changes in the abdominal muscle mass will be measured by Magnetic resonance imaging (MRI).
Time Frame
3 months
Title
Intervention induced change in muscle strength.
Description
Muscle strength will be measured by handheld dynamometer.
Time Frame
3 months
Title
Intervention induced change in glucose level and glucose metabolism.
Description
Fasting glucose level measurement and glucose tolerance test will be provided for volunteers.
Time Frame
3 months
Title
Intervention induces change in lipid profile.
Description
Measurement of total cholesterol, HDL, LDL, VLDL and triglycerides will be performed from the blood samples.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: sedentary men and women (approximately 1:1) aged 25-45 years, BMI 28-38 kg/m2 absence of chronic diseases and regular pharmacotherapy intake capable to complete a training intervention (assessment by a cardiologist) signed informed consent absence of any psychological, sociological or geographical factors that could jeopardize participation in the study Vaccination against SARS-CoV-2 with one of the approved vaccines available in Slovakia (at least 2 weeks after the last dose) and regular PCR testing during the study. Exclusion Criteria: any chronic disease (oncological, cardiovascular, neurological, liver, kidney or other diseases and its acute complications at the discretion of the doctor); No cooperation of probands; insufficient functional capacity - the presence comorbidities or disorders of the musculoskeletal system, which makes it impossible to complete the training program (assessment by cardiologist, or orthopedist or other specialist); smoking, alcohol or drugs abuse; non-compliance with epidemiological measures; absence of complete vaccination with SARS-CoV-2 vaccine; presence of a pacemaker or metal implants (contraindication for magnetic resonance imaging).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Barbara Ukropcova, Prof.
Phone
+421911643630
Email
barbara.ukropcova@sabva.sk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Ukropcova, Prof.
Organizational Affiliation
Biomedical Research Centre SAS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Biomedical Research Center Slovak Academy of Sciences
City
Bratislava
ZIP/Postal Code
84505
Country
Slovakia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara Ukropcova, Prof.
Phone
+421911643630
Email
barbara.ukropcova@savba.sk

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All IPD that underlie results in a publication
IPD Sharing Time Frame
31.12.2025 indefinitely
IPD Sharing Access Criteria
In principle to all researchers working in the area. Requests will be reviewed by Prof. Barbara Ukropcova.

Learn more about this trial

Research on Prevention, Intervention and Mechanisms of Obesity and Its Comorbidities

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