Omega 3, Leucine, Probiotic Lactobacillus Paracasei PS23 on Muscle Mass in Sarcopenic Subjects
Randomized, Placebo-controlled Clinical Study to Evaluate the Effect of 2 Months of Nutritional Support Based on Omega 3, Leucine, Probiotic Lactobacillus Paracasei PS23 (OLEP Study) on Muscle Mass in Sarcopenic Subjects
1 other identifier
interventional
54
1 country
1
Brief Summary
The purpose of the study is to evaluate the effect of supplementation with a nutritional blend based on Omega 3 fatty acids, the probiotic leucine Lactobacillus paracasei PS23 (OLEP), on muscle mass recovery in sarcopenic patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 5, 2021
CompletedFirst Posted
Study publicly available on registry
January 8, 2021
CompletedStudy Start
First participant enrolled
January 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedOctober 5, 2021
September 1, 2021
8 days
January 5, 2021
September 29, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Changes on muscle mass
Evaluation of fat free mass (g)
Baseline / 30 days / 60 days
Secondary Outcomes (13)
Changes on body composition
Baseline / 30 days / 60 days
Changes on physical performancy
Baseline / 60 days
Changes on physical performancy
Baseline / 60 days
Changes on functional status
Baseline / 60 days
Changes on functional status
Baseline / 60 days
- +8 more secondary outcomes
Study Arms (2)
OLEP
EXPERIMENTALOmega 3 (500 mg), leucine (2,5 g), probiotic Lactobacillus paracasei PS23
Placebo
PLACEBO COMPARATORisocaloric formula
Interventions
Eligibility Criteria
You may qualify if:
- Sarcopenic patients (diagnosis made according to the criteria Revised European Consensus on Definition and Diagnosis)
- Body Mass Index between 20 and 30 Kg/m2
You may not qualify if:
- severe renal failure (glomerular filtration rate \< 30 mL/min)
- moderate to severe liver failure (Child-Pugh class B or C)
- endocrine diseases associated with calcium metabolism disorders (except osteoporosis)
- known psychiatric disorders
- cancer (over the past 5 years)
- hypersensitivity to any component of the investigational nutritional supplement and
- taking to protein/amino acid supplements (up to 3 months before starting the study)
- patients unable to take oral therapy
- receiving or with indication for artificial nutrition
- who had been included in another clinical nutrition trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Azienda di Servizi alla Persona di Pavialead
- Abiogen Pharmacollaborator
Study Sites (1)
Azienda di Servizi alla Persona
Pavia, 27100, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mariangela Rondanelli
Fondazione Casemiro Mondino
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 5, 2021
First Posted
January 8, 2021
Study Start
January 22, 2021
Primary Completion
January 30, 2021
Study Completion
December 1, 2022
Last Updated
October 5, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share