NCT05938205

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
111

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2020

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 6, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 6, 2022

Completed
1 year until next milestone

First Posted

Study publicly available on registry

July 10, 2023

Completed
Last Updated

July 10, 2023

Status Verified

July 1, 2023

Enrollment Period

3.4 years

First QC Date

February 21, 2020

Last Update Submit

July 3, 2023

Conditions

Sarcopenic ObesityFrailtyMalnutrition; Protein

Outcome Measures

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

    Month0, Month5

Secondary Outcomes (6)

  • Change from baseline Short Physical Performance Battery at 5-months

    Month0, Month 5

  • Change from baseline in handgrip at 5-months

    Month0, Month5

  • Changesfrom baseline skeletal muscle mass at 5-months

    Month0, Month5

  • Change from baseline fat mass at 5-months

    Month0, Month5

  • Change from baseline in mRNA at 5-months

    Month0, Month5

  • +1 more secondary outcomes

Study Arms (3)

Exe-H + placebo

EXPERIMENTAL

high intensity physical exercise combined with placebo

Behavioral: PlaceboBehavioral: Exe-H

Exe-H + AA-1

EXPERIMENTAL

high intensity physical exercise combined with low dose of aminoacids

Dietary Supplement: AA-1Behavioral: Exe-H

Exe-H + AA-2

EXPERIMENTAL

high intensity physical exercise combined with high dose of aminoacids

Dietary Supplement: AA-2Behavioral: Exe-H

Interventions

AA-1DIETARY_SUPPLEMENT

low dose aminoacids

Exe-H + AA-1
AA-2DIETARY_SUPPLEMENT

high dose aminoacids

Exe-H + AA-2
PlaceboBEHAVIORAL

Nutritional Placebo

Exe-H + placebo
Exe-HBEHAVIORAL

high intensity physical exercise

Exe-H + AA-1Exe-H + AA-2Exe-H + placebo

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AOUI Verona

Verona, 37126, Italy

Location

Related Links

MeSH Terms

Conditions

FrailtyKwashiorkor

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsSevere Acute MalnutritionMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Elena Zoico, PhD

    Universita di Verona

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Double blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2020

First Posted

July 10, 2023

Study Start

March 1, 2019

Primary Completion

July 6, 2022

Study Completion

July 6, 2022

Last Updated

July 10, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)