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Omega 3, Leucine, Probiotic Lactobacillus Paracasei PS23 on Muscle Mass in Sarcopenic Subjects

Primary Purpose

Sarcopenia, Elderly, Omega 3

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
OLEP
Placebo
Sponsored by
Azienda di Servizi alla Persona di Pavia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcopenia

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Sarcopenic patients (diagnosis made according to the criteria Revised European Consensus on Definition and Diagnosis)
  • Body Mass Index between 20 and 30 Kg/m2

Exclusion Criteria:

  • 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

Sites / Locations

  • Azienda di Servizi alla PersonaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

OLEP

Placebo

Arm Description

Omega 3 (500 mg), leucine (2,5 g), probiotic Lactobacillus paracasei PS23

isocaloric formula

Outcomes

Primary Outcome Measures

Changes on muscle mass
Evaluation of fat free mass (g)

Secondary Outcome Measures

Changes on body composition
Evaluation of fat mass (g) and visceral adipose tissue (g)
Changes on physical performancy
Evaluation of Tinetti scale (point scale) that measures characteristics associated with falls, assessing balance (14 items; 24 points), and gait (10 items; 16 points) for a total score up to 40 (the higher the score, the better the performance)
Changes on physical performancy
Evaluation of Short Physical Performance Battery (point scale) which consists of three components: gait speed, chair-stand test, timed up and go (TUG) test (which assesses the time taken to rise from an arm chair, walk 3 m, turn, walk back, and sit down again), and balance (three different tests assessing ability to stand with the feet together in the side-by-side, semi-tandem, and tandem positions); accordingly, each component was scored from 0 (not possible) to 4 (best performance) and the scores add up to a total score ranging from 0 to 12.
Changes on functional status
Evaluation of Barthel Index (point scale) (covering all the aspects of self-care independence in daily living activities, including transfer, walking, stairs, toilet use, dressing, feeding, bladder, bowel, grooming, and bathing; score range, 0 (completely dependent) -100 (complete self-sufficiency))
Changes on functional status
Evaluation of activities of daily living score (point scale): a simplified scale that provides for the assignment of a point for each independent function in order to obtain a total performance result ranging from 0 (complete dependence) to 6 (independence in all functions).
Changes on muscle strength
Evaluation of muscle strength (kg)
Changes on Quality of life
Evaluation of Short-Form 12-Item Health Survey (poin survey): a generic health-status measure (physical component summary score and the mental component summary score) by addressing eight health domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. Score from 0 (bad quality) to 100 (high quality).
Changes on mood
Evaluation of Geriatric Depression Scale (point scale). a 30-question test with yes/no answers. 10 - 15 Points: Probable presence of depression; 6 - 9 Points: Depression possible; 0 - 5 Points: Unlikely Depression.
Changes on blood pressure
Evaluation of systolic and diastolic pressure (mm/Hg)
Changes on plasma free essential amino acids
Evaluation of free essential amino acids in plasma (Leucine, Isoleucine, Valine) (micromol/L)
Changes on safety parameters
Evaluation of creatinine (mg/dl)
Changes on safety parameters
Evaluation of alanine aminotransferase and aspartate aminotransferase (IU/L)
Changes on safety parameters
Evaluation of gamma glutamyl transferase (U/L)

Full Information

First Posted
January 5, 2021
Last Updated
September 29, 2021
Sponsor
Azienda di Servizi alla Persona di Pavia
Collaborators
Abiogen Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT04702087
Brief Title
Omega 3, Leucine, Probiotic Lactobacillus Paracasei PS23 on Muscle Mass in Sarcopenic Subjects
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 22, 2021 (Actual)
Primary Completion Date
January 30, 2021 (Actual)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Azienda di Servizi alla Persona di Pavia
Collaborators
Abiogen Pharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia, Elderly, Omega 3

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
OLEP
Arm Type
Experimental
Arm Description
Omega 3 (500 mg), leucine (2,5 g), probiotic Lactobacillus paracasei PS23
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
isocaloric formula
Intervention Type
Dietary Supplement
Intervention Name(s)
OLEP
Intervention Description
omega 3 (500 mg), leucine (2,5 g), probiotic Lactobacillus paracasei PS23
Intervention Type
Combination Product
Intervention Name(s)
Placebo
Intervention Description
Isocaloric formula
Primary Outcome Measure Information:
Title
Changes on muscle mass
Description
Evaluation of fat free mass (g)
Time Frame
Baseline / 30 days / 60 days
Secondary Outcome Measure Information:
Title
Changes on body composition
Description
Evaluation of fat mass (g) and visceral adipose tissue (g)
Time Frame
Baseline / 30 days / 60 days
Title
Changes on physical performancy
Description
Evaluation of Tinetti scale (point scale) that measures characteristics associated with falls, assessing balance (14 items; 24 points), and gait (10 items; 16 points) for a total score up to 40 (the higher the score, the better the performance)
Time Frame
Baseline / 60 days
Title
Changes on physical performancy
Description
Evaluation of Short Physical Performance Battery (point scale) which consists of three components: gait speed, chair-stand test, timed up and go (TUG) test (which assesses the time taken to rise from an arm chair, walk 3 m, turn, walk back, and sit down again), and balance (three different tests assessing ability to stand with the feet together in the side-by-side, semi-tandem, and tandem positions); accordingly, each component was scored from 0 (not possible) to 4 (best performance) and the scores add up to a total score ranging from 0 to 12.
Time Frame
Baseline / 60 days
Title
Changes on functional status
Description
Evaluation of Barthel Index (point scale) (covering all the aspects of self-care independence in daily living activities, including transfer, walking, stairs, toilet use, dressing, feeding, bladder, bowel, grooming, and bathing; score range, 0 (completely dependent) -100 (complete self-sufficiency))
Time Frame
Baseline / 60 days
Title
Changes on functional status
Description
Evaluation of activities of daily living score (point scale): a simplified scale that provides for the assignment of a point for each independent function in order to obtain a total performance result ranging from 0 (complete dependence) to 6 (independence in all functions).
Time Frame
Baseline / 60 days
Title
Changes on muscle strength
Description
Evaluation of muscle strength (kg)
Time Frame
Baseline / 30 days / 60 days
Title
Changes on Quality of life
Description
Evaluation of Short-Form 12-Item Health Survey (poin survey): a generic health-status measure (physical component summary score and the mental component summary score) by addressing eight health domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. Score from 0 (bad quality) to 100 (high quality).
Time Frame
Baseline / 60 days
Title
Changes on mood
Description
Evaluation of Geriatric Depression Scale (point scale). a 30-question test with yes/no answers. 10 - 15 Points: Probable presence of depression; 6 - 9 Points: Depression possible; 0 - 5 Points: Unlikely Depression.
Time Frame
Baseline / 60 days
Title
Changes on blood pressure
Description
Evaluation of systolic and diastolic pressure (mm/Hg)
Time Frame
Baseline / 60 days
Title
Changes on plasma free essential amino acids
Description
Evaluation of free essential amino acids in plasma (Leucine, Isoleucine, Valine) (micromol/L)
Time Frame
Baseline / 60 days
Title
Changes on safety parameters
Description
Evaluation of creatinine (mg/dl)
Time Frame
Baseline / 60 days
Title
Changes on safety parameters
Description
Evaluation of alanine aminotransferase and aspartate aminotransferase (IU/L)
Time Frame
Baseline / 60 days
Title
Changes on safety parameters
Description
Evaluation of gamma glutamyl transferase (U/L)
Time Frame
Baseline / 60 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Sarcopenic patients (diagnosis made according to the criteria Revised European Consensus on Definition and Diagnosis) Body Mass Index between 20 and 30 Kg/m2 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mariangela Rondanelli
Phone
+390382381749
Email
mariangela.rondanelli@unipv.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mariangela Rondanelli
Organizational Affiliation
Fondazione Casemiro Mondino
Official's Role
Principal Investigator
Facility Information:
Facility Name
Azienda di Servizi alla Persona
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariangela Rondanelli
Email
mariangela.rondanelli@unipv.it

12. IPD Sharing Statement

Plan to Share IPD
No

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Omega 3, Leucine, Probiotic Lactobacillus Paracasei PS23 on Muscle Mass in Sarcopenic Subjects

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