Physical Fitness as Klotho Protein Stimulator.

Aging Clinical Trial

— FIT-AGING  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03334357
• Other study ID #: FPU14/04172
• Status: Completed
• Phase: N/A
• Start date: June 1, 2016
• Est. completion date: December 23, 2017

Study information

• Verified date: October 2018
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: December 23, 2017
• Est. primary completion date: December 23, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Physical Activity

Intervention

Other:
• PAR

• HIIT

• WB-EMS

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Manuel Castillo Garzón

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	a-Klotho protein	Plasma Klotho concentrations will be measured by ELISA using a soluble a-Klotho ELISA assay kit.	Baseline and through study completion, an average of 12 weeks.
Secondary	Physical fitness: cardiorespiratory fitness	Cardiorespiratory fitness measure through a maximum treadmill test (VO2max.).	Baseline and through study completion, an average of 12 weeks.
Secondary	Physical fitness: muscular strength.	Muscle strength measure through: Isokinetic strength, Handgrip strength and Core resistance stability.	Baseline and post-intervention.Baseline and through study completion, an average of 12 weeks.
Secondary	Body composition.	Measure by DXA.	Baseline and through study completion, an average of 12 weeks.
Secondary	Resting energy expenditure.	Evaluated by indirect calorimetry with gas analyzer breath by breath.	Baseline and through study completion, an average of 12 weeks.
Secondary	Hearth Rate Variability (HRV).	Measure by Polar RS800CX.	Baseline and through study completion, an average of 12 weeks.
Secondary	Biochemical profile.	General biochemical profile in blood samples	Baseline and through study completion, an average of 12 weeks.
Secondary	Physical activity.	The amount of physical activity will be measured by accelerometer.	Baseline and through study completion, an average of 12 weeks.
Secondary	Reaction time.	Measure by Vienna System.	Baseline and through study completion, an average of 12 weeks.
Secondary	Cognitive test.	Auditory memory tests	Baseline and through study completion, an average of 12 weeks.
Secondary	Dietary assessment.	Measure by 24h recall and Food Frecuency Questionnaire.	Baseline and post-Baseline and through study completion, an average of 12 weeks..
Secondary	Anthopometric measures.	Measure by stadiometer and scale.	Baseline and post-Baseline and through study completion, an average of 12 weeks..
Secondary	Sleep quality.	The quality of sleep will be measured by accelerometer.	Baseline and post-Baseline and through study completion, an average of 12 weeks..
Secondary	Hormones profile	Hormones profile measure in blood samples.	Baseline and post-Baseline and through study completion, an average of 12 weeks..