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CompletedNCT05938205MAYBEUpdated Jul 10, 2023

Multicomponent Analysis of phYsical Frailty BiomarkErs: Focus on Mitochondrial Health - MAYBE

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

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Mar 2019, registered Feb 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
111
Allocation
Randomized
Ages
60 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Sarcopenic Obesity
  • Frailty
  • Malnutrition; Protein
03

In context

Malnutrition

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
60 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

Participants will be included in the study based on the following inclusion criteria:

  • Older men and women between 60-80 years
  • The presence of sarcopenic obesity was considered when the following two conditions were satisfied: Fat mass > 34.8% and FFM \<90% of subject's ideal FFM.
  • Resident in Verona (Italy)
  • Stable weight in the previous 2 months
  • Previously sedentary (less than one hour of exercise per week in the last 6 months)
  • Signing of the informed consent for participation in the study

Exclusion criteria

Exclusion criteria:

  • Unstable angina or recent myocardial infarction
  • Malignant or unstable arrhythmias
  • Heart failure NYHA class > II
  • Severe respiratory failure
  • Severe heart valve disease (i.e severe aortic stenosis or insufficiency)
  • Abdominal and/or thoracic aneurysm
  • Recent intracerebral or subdural haemorrhage
  • Poorly controlled arterial hypertension
  • Presence of pacemakers or metal prostheses
  • Severe chronic renal failure
  • Symptomatic musculoskeletal pathology
  • Symptomatic disc herniation, arthrosis, acute joint, tendon and ligamentous injuries, hip and/or knee prostheses recently placed (\<6 months) or with joint instability, symptomatic or large inguinal or abdominal hernia
  • Acute retinal detachment or bleeding
  • Recent eye surgery (laser, cataract, retinal surgery, glaucoma surgery)
  • History of malignant cancer within the previous 5 years
  • Diagnosis of dementia
  • Eating disorders
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
111 participants (actual)

Study arms

  • Experimental
    Exe-H + placebo

    high intensity physical exercise combined with placebo

    Behavioral: Placebo · Behavioral: Exe-H

  • Experimental
    Exe-H + AA-1

    high intensity physical exercise combined with low dose of aminoacids

    Dietary Supplement: AA-1 · Behavioral: Exe-H

  • Experimental
    Exe-H + AA-2

    high intensity physical exercise combined with high dose of aminoacids

    Dietary Supplement: AA-2 · Behavioral: Exe-H

Interventions

  • Dietary supplementAA-1

    low dose aminoacids

  • Dietary supplementAA-2

    high dose aminoacids

  • BehavioralPlacebo

    Nutritional Placebo

  • BehavioralExe-H

    high intensity physical exercise

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Change from baseline Short Physical Performance Battery at 5-months

    Change in Short Physical Performance Battery Score

    Time frame: Month0, Month 5

  2. Change from baseline in handgrip at 5-months

    Change in upper limb muscle strength measured with handgrip in kilograms

    Time frame: Month0, Month5

  3. Changesfrom baseline skeletal muscle mass at 5-months

    Change skeletal muscle mass measured with DXA in kilograms

    Time frame: Month0, Month5

  4. Change from baseline fat mass at 5-months

    Change fat mass measured with DXA in kilograms

    Time frame: Month0, Month5

  5. Change from baseline in mRNA at 5-months

    Change mRNA dosage

    Time frame: Month0, Month5

  6. Change from baseline in muscle power at 5-months

    Change in isokinetic muscle power of the lower limbs in kilograms

    Time frame: Month0, Month5

07

Study locations

1 site
  • AOUI Verona
    Verona, 37126, Italy
08

References and documents

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05938205
Lead sponsor
Azienda Ospedaliera Universitaria Integrata Verona
Collaborators
Università degli Studi di Brescia, Azienda Ospedaliera di Padova, University of Milan
Responsible party
Sponsor
First posted
Jul 10, 2023
Start date
Mar 1, 2019
Primary completion
Jul 6, 2022
Completion
Jul 6, 2022
Last update
Jul 10, 2023

Study contacts

Elena Zoico, PhD
study director · Universita di Verona

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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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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