AzTrials
AzTrials

ObesityNCT02325804

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

A study testing Lifestyle Counseling in people with Obesity, run by Slovak Academy of Sciences at 1 site in Slovakia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
Lifestyle Counseling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteSlovakia
Study dates
Dec 2014to Mar 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy Volunteers
  • BMI≥25 kg/m2

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Slovakia1 site

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

    Bratislava, 84505

Other trials in Slovakia

About this study

Official title: 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.)
Read the detailed description

I

Conditions
Obesity
Being tested
Lifestyle Counseling
Keywords
overweight and obesity, adipose tissue, weight loss program, low-calorie diet, circuit-based exercise, metabolic cardiovascular syndrome
Medical subject headings
Obesity, Overweight, Metabolic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lifestyle CounselingBehavioural

    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.

Study groups in NCT02325804
Study groupRoleWhat they receive
Conventional lifestyle counselingActive comparatorRandomized, 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
Receives: Behavioral: Lifestyle Counseling
Unconventional lifestyle counselingActive comparatorRandomized, 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
Receives: Behavioral: Lifestyle Counseling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. A Body weight change after specific weight loss intervention

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

    Measured: 8 weeks

Secondary outcomes (1)

  1. Metabolic parameters

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

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Dec 2014 (estimated)
  2. Study startDec 2014
  3. Primary completionMar 2023
  4. Study completionMar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02325804
Sponsor's protocol ID
FEXE- 11/2014
Status last verified
Apr 2023
First submitted
5 Dec 2014
Last updated
14 Apr 2023
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 24753506

  • 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.

    PubMed 23173679

  • 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.

    PubMed 21165629

  • 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.

    PubMed 20631738

  • 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.

    PubMed 20519666

  • 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.

    PubMed 19908933

  • 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.

    PubMed 19120146

  • 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.

    PubMed 18334583

  • 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.

    PubMed 17925465

  • 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.

    PubMed 17579251

  • 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.

    PubMed 16981142

  • 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.

    PubMed 16366418

  • 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.

    PubMed 15841797

  • 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.

    PubMed 39639405

  • 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.

    PubMed 37083403

Questions about this trial

What is this clinical trial studying?

A study testing Lifestyle Counseling in people with Obesity, run by Slovak Academy of Sciences at 1 site in Slovakia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

A Body weight change after specific weight loss intervention (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02325804, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2023.

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