ObesityObesityNCT05211817
Research on Prevention, Intervention and Mechanisms of Obesity and Its Comorbidities
A study testing Complex lifestyle intervention and Carnosine in people with Obesity and Exercise, run by Slovak Academy of Sciences at 1 site in Slovakia.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 45 years
- Conditions the study is for
- Obesity, Exercise, Nutrition, Healthy
- What is being tested?
- Complex lifestyle intervention and Carnosine
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSlovakia
- Study dates
- 1 Nov 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Slovakia1 site, 1 recruiting
- Recruiting
Biomedical Research Center Slovak Academy of Sciences
Bratislava, 84505
Barbara Ukropcova, Prof., +421911643630, barbara.ukropcova@savba.sk
About this study
Official title: Physical Activity and Nutrition Program in the Prevention and Treatment of Obesity, Mechanisms of Obesity and Its Comorbidities
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.
Read the 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.
- Conditions
- Obesity, Exercise, Nutrition, Healthy
- Being tested
- Complex lifestyle intervention, Carnosine
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complex lifestyle interventionBehavioural
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.
CarnosineDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Complex Intervention with Carnosine | Experimental | 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. Receives: Behavioral: Complex lifestyle intervention; Dietary Supplement: Carnosine |
| Complex Intervention with placebo | Experimental | 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. Receives: Behavioral: Complex lifestyle intervention |
| Without complex intervention with carnosine | Experimental | 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. Receives: Dietary Supplement: Carnosine |
| Without complex intervention with placebo | No intervention | Obese middle aged individuals will be subjected to standard clinical procedure without lifestyle interventions. Oral administration of identically looking placebo will be provided. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention induced change in abdominal adiposity
Body fat composition will be measured by bioelectrical impedance analysis and presented in percentage.
Measured: 3 months
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.
Measured: 3 months
Intervention induced change in abdominal muscle mass
Changes in the abdominal muscle mass will be measured by Magnetic resonance imaging (MRI).
Measured: 3 months
Intervention induced change in muscle strength.
Muscle strength will be measured by handheld dynamometer.
Measured: 3 months
Intervention induced change in glucose level and glucose metabolism.
Fasting glucose level measurement and glucose tolerance test will be provided for volunteers.
Measured: 3 months
Intervention induces change in lipid profile.
Measurement of total cholesterol, HDL, LDL, VLDL and triglycerides will be performed from the blood samples.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start1 Nov 2021
- Primary completion30 Jun 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled trial with complex lifestyle intervention and carnosine supplementation.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Slovak Academy of Sciences
- Sponsor type
- Other government
- Collaborators
- Medical University of Vienna
- Responsible party
- Principal investigator, Barbara Ukropcová, MD, PhD, Slovak Academy of Sciences
- Investigators
- Barbara Ukropcova, Prof., Principal investigator, Biomedical Research Centre SAS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05211817
- Sponsor's protocol ID
- 313011V344
- Acronym
- Obesity
- Status last verified
- Jan 2022
- First submitted
- 2 Nov 2021
- Last updated
- 27 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity and Nutrition Program in the Prevention and Treatment of Obesity, Mechanisms of Obesity and Its Comorbidities
- ClinicalTrials.gov ID
- NCT05211817
- Acronym / sponsor ID
- Obesity / 313011V344
- Conditions
- Obesity, Exercise, Nutrition, Healthy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Slovak Academy of SciencesOther government
- Collaborators
- Medical University of Vienna
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 27 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Randomised controlled trial with complex lifestyle intervention and carnosine supplementation.
| Arm | Type | Receives |
|---|---|---|
| Complex Intervention with Carnosine | Experimental | Behavioral: Complex lifestyle intervention, Dietary Supplement: CarnosineObese 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. |
| Complex Intervention with placebo | Experimental | Behavioral: Complex lifestyle interventionObese 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. |
| Without complex intervention with carnosine | Experimental | Dietary Supplement: CarnosineObese 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. |
| Without complex intervention with placebo | No intervention | –Obese middle aged individuals will be subjected to standard clinical procedure without lifestyle interventions. Oral administration of identically looking placebo will be provided. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Complex lifestyle interventionVolunteers 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. | Behavioural | Complex Intervention with Carnosine, Complex Intervention with placebo |
| Carnosine3 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. | Dietary supplement | Complex Intervention with Carnosine, Without complex intervention with carnosine |
Primary outcome
Intervention induced change in abdominal adiposity
Time frame: 3 months
Body fat composition will be measured by bioelectrical impedance analysis and presented in percentage.
Intervention induced change in VO2max.
Time frame: 3 months
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
Time frame: 3 months
Changes in the abdominal muscle mass will be measured by Magnetic resonance imaging (MRI).
Intervention induced change in muscle strength.
Time frame: 3 months
Muscle strength will be measured by handheld dynamometer.
Intervention induced change in glucose level and glucose metabolism.
Time frame: 3 months
Fasting glucose level measurement and glucose tolerance test will be provided for volunteers.
Intervention induces change in lipid profile.
Time frame: 3 months
Measurement of total cholesterol, HDL, LDL, VLDL and triglycerides will be performed from the blood samples.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2022.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Ukropcova, Prof. principal investigator
Biomedical Research Centre SAS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Complex lifestyle intervention and Carnosine in people with Obesity and Exercise, run by Slovak Academy of Sciences at 1 site in Slovakia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Barbara Ukropcova, Prof. (+421911643630, barbara.ukropcova@sabva.sk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention induced change in abdominal adiposity (time frame: 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2022; AzTrials last refreshed its copy on 8 Nov 2026.