Sarcopenic ObesityMAYBENCT05938205
Multicomponent Analysis of phYsical Frailty BiomarkErs: Focus on Mitochondrial Health - MAYBE
A study testing AA-1, AA-2 and Exe-H in people with Sarcopenic Obesity and Frailty, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenic Obesity, Frailty, Malnutrition; Protein
- What is being tested?
- AA-1, AA-2 and Exe-H
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 111 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2019to 6 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Sarcopenic Obesity, Frailty, Malnutrition; Protein
- Being tested
- AA-1, AA-2, Placebo, Exe-H
- Medical subject headings
- Frailty, Kwashiorkor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AA-1Dietary supplement
low dose aminoacids
AA-2Dietary supplement
high dose aminoacids
PlaceboBehavioural
Nutritional Placebo
Exe-HBehavioural
high intensity physical exercise
| Study group | Role | What they receive |
|---|---|---|
| Exe-H + placebo | Experimental | high intensity physical exercise combined with placebo Receives: Behavioral: Placebo; Behavioral: Exe-H |
| Exe-H + AA-1 | Experimental | high intensity physical exercise combined with low dose of aminoacids Receives: Dietary Supplement: AA-1; Behavioral: Exe-H |
| Exe-H + AA-2 | Experimental | high intensity physical exercise combined with high dose of aminoacids Receives: Dietary Supplement: AA-2; Behavioral: Exe-H |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline 1-repetition maximum with isokinetic dynamometer at 5-months
Change in 1-repetition maximum test performed with isokinetic dynamometer in Kilograms
Measured: Month0, Month5
Secondary outcomes (6)
Change from baseline Short Physical Performance Battery at 5-months
Change in Short Physical Performance Battery Score
Measured: Month0, Month 5
Change from baseline in handgrip at 5-months
Change in upper limb muscle strength measured with handgrip in kilograms
Measured: Month0, Month5
Changesfrom baseline skeletal muscle mass at 5-months
Change skeletal muscle mass measured with DXA in kilograms
Measured: Month0, Month5
Change from baseline fat mass at 5-months
Change fat mass measured with DXA in kilograms
Measured: Month0, Month5
Change from baseline in mRNA at 5-months
Change mRNA dosage
Measured: Month0, Month5
Change from baseline in muscle power at 5-months
Change in isokinetic muscle power of the lower limbs in kilograms
Measured: Month0, Month5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start1 Mar 2019
- Primary completion6 Jul 2022
- Study completion6 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sarcopenic ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata Verona
- Sponsor type
- University, hospital or other
- Collaborators
- Università degli Studi di Brescia, Azienda Ospedaliera di Padova, University of Milan
- Responsible party
- Sponsor
- Investigators
- Elena Zoico, PhD, Study director, Universita di Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05938205
- Sponsor's protocol ID
- 1956CESC
- Acronym
- MAYBE
- Status last verified
- Jul 2023
- First submitted
- 21 Feb 2020
- Last updated
- 10 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicomponent Analysis of phYsical Frailty BiomarkErs: Focus on Mitochondrial Health - MAYBE
- ClinicalTrials.gov ID
- NCT05938205
- Acronym / sponsor ID
- MAYBE / 1956CESC
- Conditions
- Sarcopenic Obesity, Frailty, Malnutrition; Protein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata VeronaUniversity, hospital or other
- Collaborators
- Università degli Studi di Brescia, Azienda Ospedaliera di Padova, University of Milan
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 6 Jul 2022 (actual)
- Study completion
- 6 Jul 2022 (actual)
- First posted
- 10 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- 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).
| Arm | Type | Receives |
|---|---|---|
| Exe-H + placebo | Experimental | Behavioral: Placebo, Behavioral: Exe-Hhigh intensity physical exercise combined with placebo |
| Exe-H + AA-1 | Experimental | Dietary Supplement: AA-1, Behavioral: Exe-Hhigh intensity physical exercise combined with low dose of aminoacids |
| Exe-H + AA-2 | Experimental | Dietary Supplement: AA-2, Behavioral: Exe-Hhigh intensity physical exercise combined with high dose of aminoacids |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AA-1low dose aminoacids | Dietary supplement | Exe-H + AA-1 |
| AA-2high dose aminoacids | Dietary supplement | Exe-H + AA-2 |
| PlaceboNutritional Placebo | Behavioural | Exe-H + placebo |
| Exe-Hhigh intensity physical exercise | Behavioural | Exe-H + AA-1, Exe-H + AA-2, Exe-H + placebo |
Primary outcome
Change from baseline 1-repetition maximum with isokinetic dynamometer at 5-months
Time frame: Month0, Month5
Change in 1-repetition maximum test performed with isokinetic dynamometer in Kilograms
6 secondary outcomes
Change from baseline Short Physical Performance Battery at 5-months
Time frame: Month0, Month 5
Change from baseline in handgrip at 5-months
Time frame: Month0, Month5
Changesfrom baseline skeletal muscle mass at 5-months
Time frame: Month0, Month5
Change from baseline fat mass at 5-months
Time frame: Month0, Month5
Change from baseline in mRNA at 5-months
Time frame: Month0, Month5
Change from baseline in muscle power at 5-months
Time frame: Month0, Month5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elena Zoico, PhD study director
Universita di Verona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AA-1, AA-2 and Exe-H in people with Sarcopenic Obesity and Frailty, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline 1-repetition maximum with isokinetic dynamometer at 5-months (time frame: Month0, Month5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2023.