Multicomponent Analysis of phYsical Frailty BiomarkErs: Focus on Mitochondrial Health - MAYBE
Condition: Sarcopenic Obesity; Frailty; Malnutrition; Protein
MeSH terms: Malnutrition; Kwashiorkor; Frailty
Study type: Interventional

Summary: 
      The study will be conducted in a group of obese sarcopenic patients (Sarco-Ob) aged > 60
      years on moderately hypocaloric diet therapy aimed at comparing the effect of a strength
      exercise protocol, combined or not with dietary supplementation with amino acids, on physical
      performance, muscle strength, body composition, muscle oxidative metabolism, and biomarkers
      of sarcopenia. The supplementation study will be conducted in a double-blind manner.
    

Detailed description: 
      In this double-blind randomised control trial, older men, and women resident in Verona
      (Italy) will be selected from the Geriatrics Nutritional Clinic of the Borgo Trento Hospital
      or were contacted by telephone. A specific medical screening was initially programmed to
      verify the criteria of recruitment.

      Anthropometric and body composition In the morning, in a fasted state, body mass will be
      taken with an electronic scale (Tanita electronic scale BWB-800 MA) and stature will be
      measured with a Harpenden stadiometer (Holtain Ltd., Crymych, Pembs. UK); BMI will be
      calculated as weight (kg)/height (m)2. Thereafter, total and regional body composition will
      be evaluated by means of dual-energy X-ray absorptiometry (DXA) using a total body scanner
      (QDR Horizon W, Hologic, MA, USA; fan-bean technology, software for Windows XP version
      12.4.2) according to the manufacturer's procedures. Furthermore, the ALMI will be calculated
      as the sum of lean mass of arms and legs divided by height squared.

      Physical performance On the same day, the SPPB test will be used to assess functional
      performance of the lower extremities. Each participant will performed: 4 m at usual customary
      gait speed, a five repeated chair-stands test and three standing balance tests (side by side,
      semi-tandem and tandem).

      A digital dynamometer (CAMRY, Digital Hand Dynamometer model: EH101) will be used to assess
      HGS and all measurements were conducted by the same operator. Before starting, participants
      will observe a demonstration of the test procedure and engage in two practice attempts.

      Knee muscle strength measurements and analysis An isokinetic dynamometer (CMSi Cybex Humac
      Norm Dynamometer, Lumex, Ronkokoma, NY, USA) will be used to assess the isokinetic strength
      of knee flexors and extensors muscles.

      Maximal isokinetic knee extension-flexion tests will be performed in a randomised sequence at
      60, 90, 150, 180 and 210°ˑs-1. Trials will consist in three knee extension-flexion movements
      with 60 s-recovery. The maximal strength of knee extensors muscle will be calculated with the
      Hill's hyperbolic function. The isokinetic knee extension-flexion power will be calculated as
      the product between strength and velocity. Finally, for knee extensors, maximal muscle power
      expressed in Watt, will be calculated from the power-velocity curve.

      1-RM assessment Before starting training intervention, participants will perform three
      sessions of familiarization with the resistance isotonic machines. High intensity strength
      exercise (Exe-H) protocol: All the participants will performed a supervised progressive
      resistance training protocol, three times per week, 1 hour per session. Each participant will
      performed the same strength training protocol, starting with 3 sets of 8-10 repetitions at
      70% of 1-RM (month 1), with a progressive increase of intensity at 75% of 1-RM (month 2 and
      month 3), and 80% 1-RM that will be maintained for the rest period of intervention. The
      compliance will be define as the number of exercise sessions expressed in % of the target
      value. Each participant will must reach a compliance above the 70% to be included in the
      final analysis.
    

Intervention name(s): AA-1; AA-2; Placebo; Exe-H
Intervention type(s): Dietary Supplement; Dietary Supplement; Behavioral; Behavioral
Intervention description(s): low dose aminoacids; high dose aminoacids; Nutritional Placebo; high intensity physical exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single-center open-label randomized experimental study with 3 parallel arms with an allocation ratio of 1:1:1. Participants will be all involved in high intensity exercise (Exe-H). Participants will be further randomized into 3 groups to receive (double-blind) dietary supplementation with either placebo, low dose amino acid blend (AA-1) or full dose amino acid blend (AA-2).
Masking: Double (Participant, Investigator)
Primary purpose: Treatment