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Effects of the Physical Fitness on Serum Klotho Levels in Healthy Population (CoFiKSa)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03509818
Recruitment Status : Completed
First Posted : April 26, 2018
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
Margarita Perez, Universidad Europea de Madrid

Study Description
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Brief Summary:
Exercise program in serum Klotho levels

Condition or disease Intervention/treatment Phase
Healthy Population Other: plyometric exercise Other: Aerobic exercise Not Applicable

Detailed Description:
This study aims to analiyze the effects of acute exercise in serum Klotho levels attending physical fitness in healthy population
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Description of the sample
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Effects of the Physical Fitness on Serum Klotho Levels in Healthy Population: Response and Adaptation
Actual Study Start Date : March 21, 2018
Actual Primary Completion Date : October 30, 2018
Actual Study Completion Date : March 26, 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: Plyometric
Effects of plyometric acute exercise
 Other: plyometric exercise
acute plyometric exercise
Experimental: Aerobic
Effects of aerobic acute exercise
 Other: Aerobic exercise
acute aerobic exercise


Outcome Measures
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Primary Outcome Measures :
  1. Change in serum Klotho levels [ Time Frame: Baseline and one hour ]
    Change from baseline to acute exercise session


Secondary Outcome Measures :
  1. Change in Cardiorespiratory Fitness VO2max [ Time Frame: Baseline ]
    For this Variable All people Will perform a exercise test on treadmill (Tecnhogym run race 1400HC; Gambettola, Italy), in this way we determinate the VO2max. Through the modifies Balke protocol. The gas Exchange data Will measured breath by breath using open circuit spirometry and specific face mask for Fitmate, Cosmed; Vmax 29C, Sensormedics machine.

  2. Change in Body Composition [ Time Frame: Baseline ]
    The age in years; height in centimeters (tallimeter Ano Sayol SL, Barcelona, Spain); weight in kilograms (Inbody 720, Microcaya) and we can derive from this data the variable of Body Mass Index (BMI) calculated as weight (kg)/height (m2).

  3. Change in Body Composition, Body muscle mass Index [ Time Frame: Baseline ]
    For determinate this variable of the body composition will be use a Dual Densitometry X-Ray (DXA) (Hologic QDR Discovery, Bedford, MA, USA)

  4. Change in Body Composition, % of Fat Mass [ Time Frame: Baseline ]
    For determinate this variable of the body composition will be use a Dual Densitometry X-Ray (DXA) (Hologic QDR Discovery, Bedford, MA, USA)

  5. Change in Body Composition, Total Muscle Mass [ Time Frame: Baseline ]
    For determinate this variable of the body composition will be use a Dual Densitometry X-Ray (DXA) (Hologic QDR Discovery, Bedford, MA, USA)

  6. Change in Body Composition, Visceral Fat Index. [ Time Frame: Baseline ]
    For determinate this variable of the body composition will be use a Dual Densitometry X-Ray (DXA) (Hologic QDR Discovery, Bedford, MA, USA). This value is really important to determine a cardiovascular risk.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy people between 20 and 45 years old

Exclusion Criteria:

  • acute and chronic disease, people who take medication and supplements, smoker.
Contacts and Locations
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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): NCT03509818


Locations
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Spain
Escuela de Doctorado e Invesitgacion, Universidad Europea
Madrid, Villaviciosa De Odon, Spain, 28670
Sponsors and Collaborators
Universidad Europea de Madrid
Investigators
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Principal Investigator: Valentin Fernandez Elias, Ph Universidad Europea de Madrid
More Information
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Responsible Party: Margarita Perez, Professor in Exercise Physiology, Universidad Europea de Madrid
ClinicalTrials.gov Identifier: NCT03509818    
Other Study ID Numbers: Ref 47/764390.09/17
First Posted: April 26, 2018    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Margarita Perez, Universidad Europea de Madrid:
Klotho
Exercise
Physical Fitness