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Completed

NCT Number: NCT03334357

Physical Fitness as Klotho Protein Stimulator.

FIT-AGING will determine the effect of different exercise modalities on α-Klotho protein (primary outcome) in sedentary healthy adults. FIT-AGING also investigate the physiological consequences of activating Klotho gene (secondary outcomes).

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Key information

Conditions

Physical Activity Aging Behavior Motor Activity

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Aims: The plasma Klotho protein concentration (α-Klotho protein), which is considered a powerful biomarker of longevity, makes it an attractive target as an anti-aging therapy against functional decline, sarcopenic obesity, metabolic and cardiovascular diseases, osteoporosis, and neurodegenerative disorders. Physical exercise and physical fitness, could be α-Klotho protein activators through biochemical process. FIT-AGING will determine the effect of different exercise modalities on α-Klotho protein (primary outcome) in sedentary healthy adults. FIT-AGING also investigate the physiological consequences of activating Klotho gene (secondary outcomes).

Methods: FIT-AGING will recruit 60 sedentary, healthy, adults (50% women) aged 40-65 years. Eligible participants will be randomly assigned to a non-exercise group to the usual control group (n=15), physical activity recommendation from American College of Sport Medicine, World Health Organization and American Heart Association group (n=15), High Intensity Interval Training group (n=15)) and Whole-Body Electromyostimulation group (n=15). Laboratory measures completed at baseline and 12 weeks later, include α-Klotho protein concentration, physical fitness (cardiorespiratory fitness, muscular strength), body composition, resting metabolic rate, hearth rate variability (HRV), health blood biomarkers, free-living physical activity, sleep habits reaction time, cognitive variables and health-related questionnaires. The investigators will also obtain dietary habits data and cardiovascular disease risk factors.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age: 40-65 years
  • BMI:18.5-35 kg/m2
  • Not engaged in regular physical activity >20min on >3days/week
  • Not participating in a weight loss programme
  • Stable weight over the last 5 months (body weight changes>5kg)
  • Participant must be capable and willing to provide consent, understand exclusion criteria and accept the randomized group assignment
  • Normal electrocardiogram

Exclusion criteria

  • History of cardiovascular disease
  • Diabetes
  • Pregnancy or planning to get pregnant during study period
  • Beta blockers or benzodiapezins use
  • Taking medication for thyroid
  • Other significant conditions that are life-threatening or that can interfere with or be aggravated by exercise
  • Unwillingness to either complete the study requirements or to be randomized into control or training group
  • A first-degree relative with history of cancer

Treatment and study plan

PAR

Other

HIIT

Other

WB-EMS

Other

Primary outcomes

  1. α-Klotho protein

    Time frame: Baseline and through study completion, an average of 12 weeks.

    Plasma Klotho concentrations will be measured by ELISA using a soluble α-Klotho ELISA assay kit.

Secondary outcomes

  1. Physical fitness: cardiorespiratory fitness

    Time frame: Baseline and through study completion, an average of 12 weeks.

    Cardiorespiratory fitness measure through a maximum treadmill test (VO2max.).

  2. Physical fitness: muscular strength.

    Time frame: Baseline and post-intervention.Baseline and through study completion, an average of 12 weeks.

    Muscle strength measure through: Isokinetic strength, Handgrip strength and Core resistance stability.

  3. Body composition.

    Time frame: Baseline and through study completion, an average of 12 weeks.

    Measure by DXA.

  4. Resting energy expenditure.

    Time frame: Baseline and through study completion, an average of 12 weeks.

    Evaluated by indirect calorimetry with gas analyzer breath by breath.

  5. Hearth Rate Variability (HRV).

    Time frame: Baseline and through study completion, an average of 12 weeks.

    Measure by Polar RS800CX.

  6. Biochemical profile.

    Time frame: Baseline and through study completion, an average of 12 weeks.

    General biochemical profile in blood samples

  7. Physical activity.

    Time frame: Baseline and through study completion, an average of 12 weeks.

    The amount of physical activity will be measured by accelerometer.

  8. Reaction time.

    Time frame: Baseline and through study completion, an average of 12 weeks.

    Measure by Vienna System.

  9. Cognitive test.

    Time frame: Baseline and through study completion, an average of 12 weeks.

    Auditory memory tests

  10. Dietary assessment.

    Time frame: Baseline and post-Baseline and through study completion, an average of 12 weeks..

    Measure by 24h recall and Food Frecuency Questionnaire.

  11. Anthopometric measures.

    Time frame: Baseline and post-Baseline and through study completion, an average of 12 weeks..

    Measure by stadiometer and scale.

  12. Sleep quality.

    Time frame: Baseline and post-Baseline and through study completion, an average of 12 weeks..

    The quality of sleep will be measured by accelerometer.

  13. Hormones profile

    Time frame: Baseline and post-Baseline and through study completion, an average of 12 weeks..

    Hormones profile measure in blood samples.

Sponsors and collaborators

Lead sponsor

Manuel Castillo Garzón

Other

Registry information

Official study title

Physical Fitness as Klotho Protein Stimulator; Antiaging Effects of New Training Methods (FIT-AGING).

Acronym: FIT-AGING

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 7, 2017
Registry last updated
Oct 12, 2018

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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