Effect of Specific Diet and Physical Activity on Weight and/or Fat Loss

April 11, 2023 updated by: Adela Penesova, MD, PhD, Slovak Academy of Sciences

Effect of Specific Diet and Circuit-based Exercise on Weight and/or Fat Loss

The main purpose of this study is to assess metabolic effects (decreased amount of body fat content, insulin sensitivity and lipid profile improvement) of weight loss intervention based on specific life style counseling (low calorie "metabolic stairs" diet and circuit-based exercise in a comparison to conventional diet and exercise. The main hypothesis is that more significant beneficial metabolic effects will have specific life style counseling effect than conventional diet and exercise. The main purpose of this study is to assess above mentioned metabolic changes before and after 6-8 weeks of weight loss intervention.

The investigators will also study the following:

  1. The impact of life style counseling induced weight and/or fat loss on physical fitness
  2. The impact of life style counseling induced weight and/or fat loss on metabolic parameters (e.g. insulin sensitivity, lipid profile, ect.)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

I

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovakia
      • Bratislava, Slovakia, 84505
        • Biomedical Center, Slovak Academy of Sciences, Institute of clinical and translational reasearch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy Volunteers
  • BMI≥25 kg/m2

Exclusion Criteria:

  • Thyroid disease
  • Chronic diseases(rheumatic,liver, kidney, pulmonary, etc. diseases) have current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease, or diabetes;
  • chronic infections
  • show evidence of malignancy
  • be women who are pregnant, nursing
  • medical treatment except allergy medicines
  • tobacco, alcohol or drug addiction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional lifestyle counseling
Randomized, open label study to assess effect of 8 weeks of Conventional lifestyle counseling (low calorie diet and exercise) on body composition, physical fitness, and metabolic parameters
Behavioral: Lifestyle Counseling
In both arms life style counseling: Low calorie diet- 30% reduction of weight maintenance calories (TDEE); and recommended moderate exercise 3 times per week 45 minutes.
Active Comparator: Unconventional lifestyle counseling
Randomized, open label study to assess effect of 8 weeks of unconventional lifestyle counseling (low calorie "metabolic stairs" diet and circuit-based exercise) on body composition, physical fitness, and metabolic parameters
Behavioral: Lifestyle Counseling
In both arms life style counseling: Low calorie diet- 30% reduction of weight maintenance calories (TDEE); and recommended moderate exercise 3 times per week 45 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A Body weight change after specific weight loss intervention
Time Frame: 8 weeks
To assess the body composition changes (fat-free mass and fat mass (in kg)).
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metabolic parameters
Time Frame: 8 weeks
  • Insulin sensitivity
  • Total, HDL, LDL, small dense-LDL cholesterol levels
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Slovak Academy of Sciences

Investigators

  • Principal Investigator: Adela Penesova, MD, PhD, Biomedical center, Slovak Academy of Sciences, Institute of clinical and translational researchBratislava, 833 06, SLOVAKIA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

March 1, 2023

Study Completion (Actual)

March 1, 2023

Study Registration Dates

First Submitted

December 5, 2014

First Submitted That Met QC Criteria

December 21, 2014

First Posted (Estimate)

December 25, 2014

Study Record Updates

Last Update Posted (Actual)

April 14, 2023

Last Update Submitted That Met QC Criteria

April 11, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FEXE- 11/2014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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