Physical Fitness as Klotho Protein Stimulator.
- Conditions
- Physical ActivityAging
- Registration Number
- NCT03334357
- Lead Sponsor
- Manuel Castillo Garzón
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 74
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method α-Klotho protein 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 Outcome Measures
Name Time Method Physical fitness: cardiorespiratory fitness Baseline and through study completion, an average of 12 weeks. Cardiorespiratory fitness measure through a maximum treadmill test (VO2max.).
Physical fitness: muscular strength. 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.
Body composition. Baseline and through study completion, an average of 12 weeks. Measure by DXA.
Resting energy expenditure. Baseline and through study completion, an average of 12 weeks. Evaluated by indirect calorimetry with gas analyzer breath by breath.
Hearth Rate Variability (HRV). Baseline and through study completion, an average of 12 weeks. Measure by Polar RS800CX.
Biochemical profile. Baseline and through study completion, an average of 12 weeks. General biochemical profile in blood samples
Physical activity. Baseline and through study completion, an average of 12 weeks. The amount of physical activity will be measured by accelerometer.
Reaction time. Baseline and through study completion, an average of 12 weeks. Measure by Vienna System.
Cognitive test. Baseline and through study completion, an average of 12 weeks. Auditory memory tests
Dietary assessment. Baseline and post-Baseline and through study completion, an average of 12 weeks.. Measure by 24h recall and Food Frecuency Questionnaire.
Anthopometric measures. Baseline and post-Baseline and through study completion, an average of 12 weeks.. Measure by stadiometer and scale.
Sleep quality. Baseline and post-Baseline and through study completion, an average of 12 weeks.. The quality of sleep will be measured by accelerometer.
Hormones profile Baseline and post-Baseline and through study completion, an average of 12 weeks.. Hormones profile measure in blood samples.