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OpenTrials
Completed

NCT Number: NCT02325804

Effect of Specific Diet and Physical Activity 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.)

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Key information

Conditions

Obesity Body Weight Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Biomedical Center, Slovak Academy of Sciences, Institute of clinical and translational reasearch

Bratislava, 84505, Slovakia

About this study

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifestyle Counseling

Behavioral

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.

Primary outcomes

  1. 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)).

Secondary outcomes

  1. Metabolic parameters

    Time frame: 8 weeks

    • Insulin sensitivity
    • Total, HDL, LDL, small dense-LDL cholesterol levels

Sponsors and collaborators

Lead sponsor

Slovak Academy of Sciences

Other Gov

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2023
Study completion
2023
First posted
Dec 25, 2014
Registry last updated
Apr 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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