NCT05211817

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 2, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 27, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

January 27, 2022

Status Verified

January 1, 2022

Enrollment Period

1.7 years

First QC Date

November 2, 2021

Last Update Submit

January 14, 2022

Conditions

ObesityExerciseNutrition, Healthy

Outcome Measures

Primary Outcomes (6)

  • Intervention induced change in abdominal adiposity

    Body fat composition will be measured by bioelectrical impedance analysis and presented in percentage.

    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.

    3 months

  • Intervention induced change in abdominal muscle mass

    Changes in the abdominal muscle mass will be measured by Magnetic resonance imaging (MRI).

    3 months

  • Intervention induced change in muscle strength.

    Muscle strength will be measured by handheld dynamometer.

    3 months

  • Intervention induced change in glucose level and glucose metabolism.

    Fasting glucose level measurement and glucose tolerance test will be provided for volunteers.

    3 months

  • Intervention induces change in lipid profile.

    Measurement of total cholesterol, HDL, LDL, VLDL and triglycerides will be performed from the blood samples.

    3 months

Study Arms (4)

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.

Behavioral: Complex lifestyle interventionDietary 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.

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.

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.

Interventions

Complex lifestyle interventionBEHAVIORAL

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.

Complex Intervention with CarnosineComplex Intervention with placebo
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.

Complex Intervention with CarnosineWithout complex intervention with carnosine

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biomedical Research Center Slovak Academy of Sciences

Bratislava, 84505, Slovakia

RECRUITING

MeSH Terms

Conditions

ObesityMotor Activity

Interventions

Carnosine

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

NeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsDipeptidesOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • Barbara Ukropcova, Prof.

    Biomedical Research Centre SAS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Barbara Ukropcova, Prof.

CONTACT

+421911643630barbara.ukropcova@sabva.sk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Block randomisation for carnosine, identically looking control and intervention treatment
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomised controlled trial with complex lifestyle intervention and carnosine supplementation.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 2, 2021

First Posted

January 27, 2022

Study Start

November 1, 2021

Primary Completion

June 30, 2023

Study Completion

December 31, 2023

Last Updated

January 27, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will share

All IPD that underlie results in a publication

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
31.12.2025 indefinitely
Access Criteria
In principle to all researchers working in the area. Requests will be reviewed by Prof. Barbara Ukropcova.

Locations

SL(1)