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

NCT02325804 | Completed

• 1 other identifier: FEXE- 11/2014
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Obesity

Keywords

overweight and obesity; adipose tissue; weight loss program; low-calorie diet; circuit-based exercise; metabolic cardiovascular syndrome

Outcome Measures

Primary Outcomes (1)

• A Body weight change after specific weight loss intervention

  To assess the body composition changes (fat-free mass and fat mass (in kg)).

  8 weeks

Secondary Outcomes (1)

• Metabolic parameters

  8 weeks

Study Arms (2)

Conventional lifestyle counseling

ACTIVE COMPARATOR

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

Unconventional lifestyle counseling

ACTIVE COMPARATOR

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

Interventions

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.

Conventional lifestyle counseling; Unconventional lifestyle counseling

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy Volunteers
• BMI≥25 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• Slovak Academy of Sciences: lead

Study Sites (1)

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

Bratislava, 84505, Slovakia

Location

Related Publications (16)

• Balaz M, Vician M, Janakova Z, Kurdiova T, Surova M, Imrich R, Majercikova Z, Penesova A, Vlcek M, Kiss A, Belan V, Klimes I, Olejnik J, Gasperikova D, Wolfrum C, Ukropcova B, Ukropec J. Subcutaneous adipose tissue zinc-alpha2-glycoprotein is associated with adipose tissue and whole-body insulin sensitivity. Obesity (Silver Spring). 2014 Aug;22(8):1821-9. doi: 10.1002/oby.20764. Epub 2014 Apr 22.

  PMID: 24753506 BACKGROUND

• Penesova A, Radikova Z, Vlcek M, Kerlik J, Lukac J, Rovensky J, Imrich R. Chronic inflammation and low-dose glucocorticoid effects on glucose metabolism in premenopausal females with rheumatoid arthritis free of conventional metabolic risk factors. Physiol Res. 2013;62(1):75-83. doi: 10.33549/physiolres.932359. Epub 2012 Nov 22.

  PMID: 23173679 BACKGROUND

• Penesova A, Venti CA, Bunt JC, Bonfiglio SM, Votruba SB, Krakoff J. Short-term isocaloric manipulation of carbohydrate intake: effect on subsequent ad libitum energy intake. Eur J Nutr. 2011 Sep;50(6):455-63. doi: 10.1007/s00394-010-0152-5. Epub 2010 Dec 17.

  PMID: 21165629 BACKGROUND

• Penesova A, Cizmarova E, Belan V, Blazicek P, Imrich R, Vlcek M, Vigas M, Selko D, Koska J, Radikova Z. Insulin resistance in young, lean male subjects with essential hypertension. J Hum Hypertens. 2011 Jun;25(6):391-400. doi: 10.1038/jhh.2010.72. Epub 2010 Jul 15.

  PMID: 20631738 BACKGROUND

• Penesova A, Bunt JC, Bogardus C, Krakoff J. Effect of paternal diabetes on pre-diabetic phenotypes in adult offspring. Diabetes Care. 2010 Aug;33(8):1823-8. doi: 10.2337/dc10-0664. Epub 2010 Jun 2.

  PMID: 20519666 BACKGROUND

• Eckertova M, Krskova K, Penesova A, Radikova Z, Zlnay D, Rovensky J, Zorad S. Impaired insulin secretion and uptake in patients with diffuse idiopathic skeletal hyperostosis. Endocr Regul. 2009 Oct;43(4):149-55.

  PMID: 19908933 BACKGROUND

• Penesova A, Radikova Z, Cizmarova E, Kvetnansky R, Blazicek P, Vlcek M, Koska J, Vigas M. The role of norepinephrine and insulin resistance in an early stage of hypertension. Ann N Y Acad Sci. 2008 Dec;1148:490-4. doi: 10.1196/annals.1410.036.

  PMID: 19120146 BACKGROUND

• Ukropec J, Penesova A, Skopkova M, Pura M, Vlcek M, Radikova Z, Imrich R, Ukropcova B, Tajtakova M, Koska J, Zorad S, Belan V, Vanuga P, Payer J, Eckel J, Klimes I, Gasperikova D. Adipokine protein expression pattern in growth hormone deficiency predisposes to the increased fat cell size and the whole body metabolic derangements. J Clin Endocrinol Metab. 2008 Jun;93(6):2255-62. doi: 10.1210/jc.2007-2188. Epub 2008 Mar 11.

  PMID: 18334583 BACKGROUND

• Skopkova M, Penesova A, Sell H, Radikova Z, Vlcek M, Imrich R, Koska J, Ukropec J, Eckel J, Klimes I, Gasperikova D. Protein array reveals differentially expressed proteins in subcutaneous adipose tissue in obesity. Obesity (Silver Spring). 2007 Oct;15(10):2396-406. doi: 10.1038/oby.2007.285.

  PMID: 17925465 BACKGROUND

• Jurkovicova D, Sedlakova B, Riecansky I, Goncalvesova E, Penesova A, Kvetnansky R, Krizanova O. Cardiovascular diseases and molecular variants of the renin-angiotensin system components in Slovak population. Gen Physiol Biophys. 2007 Mar;26(1):27-32.

  PMID: 17579251 BACKGROUND

• Penesova A, Cizmarova E, Kvetnansky R, Koska J, Sedlakova B, Krizanova O. Insertion/deletion polymorphism on ACE gene is associated with endothelial dysfunction in young patients with hypertension. Horm Metab Res. 2006 Sep;38(9):592-7. doi: 10.1055/s-2006-951307.

  PMID: 16981142 BACKGROUND

• Penesova A, Rovensky J, Zlnay M, Dedik L, Radikova Z, Koska J, Vigas M, Imrich R. Attenuated insulin response and normal insulin sensitivity in lean patients with ankylosing spondylitis. Int J Clin Pharmacol Res. 2005;25(3):107-14.

  PMID: 16366418 BACKGROUND

• Penesova A, Radikova Z. Comparison of insulin sensitivity indices calculated from standard 3-sampled and frequently sampled oral glucose tolerance test. Endocr Regul. 2004 Dec;38(4):167-71.

  PMID: 15841797 BACKGROUND

• Nechalova L, Bielik V, Hric I, Babicova M, Baranovicova E, Grendar M, Koska J, Penesova A. Gut microbiota and metabolic responses to a 12-week caloric restriction combined with strength and HIIT training in patients with obesity: a randomized trial. BMC Sports Sci Med Rehabil. 2024 Dec 5;16(1):239. doi: 10.1186/s13102-024-01029-7.

  PMID: 39639405 DERIVED

• Kubanova L, Bielik V, Hric I, Ugrayova S, Soltys K, Radikova Z, Baranovicova E, Grendar M, Kolisek M, Penesova A. Gut Microbiota and Serum Metabolites in Individuals with Class III Obesity Without Type 2 Diabetes Mellitus: Pilot Analysis. Metab Syndr Relat Disord. 2023 Jun;21(5):243-253. doi: 10.1089/met.2022.0071. Epub 2023 Apr 20.

  PMID: 37083403 DERIVED

• Bajer B, Radikova Z, Havranova A, Zitnanova I, Vlcek M, Imrich R, Sabaka P, Bendzala M, Penesova A. Effect of 8-weeks intensive lifestyle intervention on LDL and HDL subfractions. Obes Res Clin Pract. 2019 Nov-Dec;13(6):586-593. doi: 10.1016/j.orcp.2019.10.010. Epub 2019 Dec 2.

  PMID: 31806470 DERIVED

MeSH Terms

Conditions

Obesity; Overweight; Metabolic Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• Adela Penesova, MD, PhD

  Biomedical center, Slovak Academy of Sciences, Institute of clinical and translational researchBratislava, 833 06, SLOVAKIA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Biomedical Center of Slovak Academy of Sciences, Institute of clinical and translational research

Study Record Dates

• First Submitted: December 5, 2014
• First Posted: December 25, 2014
• Study Start: December 1, 2014
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: April 14, 2023

Record last verified: 2023-04

Locations

SL (1)