Clinical trial NCT03334357: Physical Fitness as Klotho Protein Stimulator.
Official title: Physical Fitness as Klotho Protein Stimulator; Antiaging Effects of New Training Methods (FIT-AGING).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Aging
Keywords: Physical fitness
Klotho
Training
HIIT
WB-EMS
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2017-11-07
Enrollment: 74
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: α-Klotho protein
timeFrame: Baseline and through study completion, an average of 12 weeks.
Secondary outcomes:
measure: Physical fitness: cardiorespiratory fitness
timeFrame: Baseline and through study completion, an average of 12 weeks.
measure: Physical fitness: muscular strength.
timeFrame: Baseline and post-intervention.Baseline and through study completion, an average of 12 weeks.
measure: Body composition.
timeFrame: Baseline and through study completion, an average of 12 weeks.
measure: Resting energy expenditure.
timeFrame: Baseline and through study completion, an average of 12 weeks.
measure: Hearth Rate Variability (HRV).
timeFrame: Baseline and through study completion, an average of 12 weeks.
measure: Biochemical profile.
timeFrame: Baseline and through study completion, an average of 12 weeks.
measure: Physical activity.
timeFrame: Baseline and through study completion, an average of 12 weeks.
measure: Reaction time.
timeFrame: Baseline and through study completion, an average of 12 weeks.
measure: Cognitive test.
timeFrame: Baseline and through study completion, an average of 12 weeks.
measure: Dietary assessment.
timeFrame: Baseline and post-Baseline and through study completion, an average of 12 weeks..
measure: Anthopometric measures.
timeFrame: Baseline and post-Baseline and through study completion, an average of 12 weeks..
measure: Sleep quality.
timeFrame: Baseline and post-Baseline and through study completion, an average of 12 weeks..
measure: Hormones profile
timeFrame: Baseline and post-Baseline and through study completion, an average of 12 weeks..
Other outcomes:
Locations:
Study officials:
affiliation: Universidad de Granada
name: Manuel J Castillo Garzón, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Navarro-Lomas G, Dote-Montero M, Alcantara JMA, Plaza-Florido A, Castillo MJ, Amaro-Gahete FJ. Different exercise training modalities similarly improve heart rate variability in sedentary middle-aged adults: the FIT-AGEING randomized controlled trial. Eur J Appl Physiol. 2022 Aug;122(8):1863-1874. doi: 10.1007/s00421-022-04957-9. Epub 2022 May 10.
citation: Dote-Montero M, De-la-O A, Jurado-Fasoli L, Ruiz JR, Castillo MJ, Amaro-Gahete FJ. The effects of three types of exercise training on steroid hormones in physically inactive middle-aged adults: a randomized controlled trial. Eur J Appl Physiol. 2021 Aug;121(8):2193-2206. doi: 10.1007/s00421-021-04692-7. Epub 2021 Apr 22.
citation: Jurado-Fasoli L, Amaro-Gahete FJ, Merchan-Ramirez E, Labayen I, Ruiz JR. Relationships between diet and basal fat oxidation and maximal fat oxidation during exercise in sedentary adults. Nutr Metab Cardiovasc Dis. 2021 Apr 9;31(4):1087-1101. doi: 10.1016/j.numecd.2020.11.021. Epub 2020 Dec 1.
citation: De-la-O A, Jurado-Fasoli L, Castillo MJ, Gutierrez A, Amaro-Gahete FJ. 1,25-Dihydroxyvitamin D and S-Klotho Plasma Levels: The Relationship Between Two Renal Antiaging Biomarkers Mediated by Bone Mineral Density in Middle-Aged Sedentary Adults. Rejuvenation Res. 2021 Jun;24(3):227-233. doi: 10.1089/rej.2020.2384. Epub 2021 Mar 5.
citation: Amaro-Gahete FJ, Sanchez-Delgado G, Ara I, R Ruiz J. Cardiorespiratory Fitness May Influence Metabolic Inflexibility During Exercise in Obese Persons. J Clin Endocrinol Metab. 2019 Dec 1;104(12):5780-5790. doi: 10.1210/jc.2019-01225.
citation: Jurado-Fasoli L, Amaro-Gahete FJ, De-la-O A, Castillo MJ. Impact of different exercise training modalities on energy and nutrient intake and food consumption in sedentary middle-aged adults: a randomised controlled trial. J Hum Nutr Diet. 2020 Feb;33(1):86-97. doi: 10.1111/jhn.12673. Epub 2019 Jul 3.