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

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Behavioral: Lifestyle Counseling

• Registration Number: NCT02325804
• Lead Sponsor: Slovak Academy of Sciences

Brief Summary

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.)

Detailed Description

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Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2014-12-05
• Study First Submitted QC: 2014-12-21
• Study First Posted: 2014-12-25
• Primary Completion: 2023-03
• Study Completion: 2023-03
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-11
• Last Update Posted: 2023-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Conventional lifestyle counseling	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
Unconventional lifestyle counseling	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

Primary Outcome Measures

Name	Time	Method
A Body weight change after specific weight loss intervention	8 weeks	To assess the body composition changes (fat-free mass and fat mass (in kg)).

Secondary Outcome Measures

Name	Time	Method
Metabolic parameters	8 weeks	* Insulin sensitivity; * Total, HDL, LDL, small dense-LDL cholesterol levels

Trial Locations

Locations (1)

Biomedical Center, Slovak Academy of Sciences, Institute of clinical and translational reasearch; 🇸🇰 Bratislava, Slovakia