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Trial record 26 of 1645 for:    Slovakia

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

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ClinicalTrials.gov Identifier: NCT02325804
Recruitment Status : Unknown
Verified April 2016 by Adela Penesova, MD, PhD, Slovak Academy of Sciences.
Recruitment status was:  Recruiting
First Posted : December 25, 2014
Last Update Posted : April 27, 2016
Sponsor:
Information provided by (Responsible Party):
Adela Penesova, MD, PhD, 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.)

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Lifestyle Counseling Not Applicable

Detailed Description:
I

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Specific Diet and Circuit-based Exercise on Weight and/or Fat Loss
Study Start Date : December 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  1. Metabolic parameters [ Time Frame: 8 weeks ]
    • Insulin sensitivity
    • Total, HDL, LDL, small dense-LDL cholesterol levels



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02325804


Contacts
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Contact: Adela Penesova, MD, PhD 00421 2 32295245 adela.penesova@savba.sk
Contact: Miroslav Vlcek, MD, PhD 00421 2 32295244 miroslav.vlcek@savba.sk

Locations
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Slovakia
Biomedical Center, Slovak Academy of Sciences, Institute of clinical and translational reasearch Recruiting
Bratislava, Slovakia, 84505
Contact: Adela Penesova, MD. PhD    00421 2 54774942    adela.penesova@savba.sk   
Contact: Miroslav Vlcek, MD. PhD    00421 2 54774942    miroslav.vlcek@savba.sk   
Sub-Investigator: Richard Imrich, MD. PhD         
Sub-Investigator: Boris Bajer, MD         
Sponsors and Collaborators
Slovak Academy of Sciences
Investigators
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Principal Investigator: Adela Penesova, MD, PhD Biomedical center, Slovak Academy of Sciences, Institute of clinical and translational researchBratislava, 833 06, SLOVAKIA

Publications:

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Responsible Party: Adela Penesova, MD, PhD, Biomedical Center of Slovak Academy of Sciences, Institute of clinical and translational research, Slovak Academy of Sciences
ClinicalTrials.gov Identifier: NCT02325804     History of Changes
Other Study ID Numbers: FEXE- 11/2014
First Posted: December 25, 2014    Key Record Dates
Last Update Posted: April 27, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Adela Penesova, MD, PhD, Slovak Academy of Sciences:
overweight and obesity
adipose tissue
weight loss program
low-calorie diet
circuit-based exercise
metabolic cardiovascular syndrome
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms