An interventional study of AA-1 and AA-2 in Sarcopenic Obesity, Frailty and Malnutrition; Protein, sponsored by Azienda Ospedaliera Universitaria Integrata Verona. Completed at 1 site in Italy. Open to participants aged 60 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-10.
Sponsored by Azienda Ospedaliera Universitaria Integrata Verona · Not applicable, Interventional, and Treatment
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.
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.
1,588 studies on the registry are indexed under Malnutrition; 237 are open to participants now.
This study's enrollment of 111 is above the median of 90 across 1,135 interventional studies indexed under Malnutrition.
Browse Malnutrition studies →Azienda Ospedaliera Universitaria Integrata Verona is the lead sponsor of 92 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants will be included in the study based on the following inclusion criteria:
Exclusion criteria:
high intensity physical exercise combined with placebo
Behavioral: Placebo · Behavioral: Exe-H
high intensity physical exercise combined with low dose of aminoacids
Dietary Supplement: AA-1 · Behavioral: Exe-H
high intensity physical exercise combined with high dose of aminoacids
Dietary Supplement: AA-2 · Behavioral: Exe-H
low dose aminoacids
high dose aminoacids
Nutritional Placebo
high intensity physical exercise
Change from baseline 1-repetition maximum with isokinetic dynamometer at 5-months
Change in 1-repetition maximum test performed with isokinetic dynamometer in Kilograms
Time frame: Month0, Month5
Change from baseline Short Physical Performance Battery at 5-months
Change in Short Physical Performance Battery Score
Time frame: Month0, Month 5
Change from baseline in handgrip at 5-months
Change in upper limb muscle strength measured with handgrip in kilograms
Time frame: Month0, Month5
Changesfrom baseline skeletal muscle mass at 5-months
Change skeletal muscle mass measured with DXA in kilograms
Time frame: Month0, Month5
Change from baseline fat mass at 5-months
Change fat mass measured with DXA in kilograms
Time frame: Month0, Month5
Change from baseline in mRNA at 5-months
Change mRNA dosage
Time frame: Month0, Month5
Change from baseline in muscle power at 5-months
Change in isokinetic muscle power of the lower limbs in kilograms
Time frame: Month0, Month5
Plan to share: No
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Azienda Ospedaliera Universitaria Integrata Verona