SarcopeniaNCT04702087
Omega 3, Leucine, Probiotic Lactobacillus Paracasei PS23 on Muscle Mass in Sarcopenic Subjects
A study testing OLEP in people with Sarcopenia and Elderly, run by Azienda di Servizi alla Persona di Pavia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Elderly, Omega 3
- What is being tested?
- OLEP
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteItaly
- Study dates
- 22 Jan 2021to Dec 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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Sarcopenic patients (diagnosis made according to the criteria Revised European Consensus on Definition and Diagnosis)
- Body Mass Index between 20 and 30 Kg/m2
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Azienda di Servizi alla Persona
Pavia, 27100
Mariangela Rondanelli, mariangela.rondanelli@unipv.it
About this study
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
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.
- Conditions
- Sarcopenia, Elderly, Omega 3
- Being tested
- OLEP, Placebo
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OLEPDietary supplement
omega 3 (500 mg), leucine (2,5 g), probiotic Lactobacillus paracasei PS23
PlaceboCombination product
Isocaloric formula
| Study group | Role | What they receive |
|---|---|---|
| OLEP | Experimental | Omega 3 (500 mg), leucine (2,5 g), probiotic Lactobacillus paracasei PS23 Receives: Dietary Supplement: OLEP |
| Placebo | Placebo comparator | isocaloric formula Receives: Combination Product: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes on muscle mass
Evaluation of fat free mass (g)
Measured: Baseline / 30 days / 60 days
Secondary outcomes (13)
Changes on body composition
Evaluation of fat mass (g) and visceral adipose tissue (g)
Measured: Baseline / 30 days / 60 days
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)
Measured: Baseline / 60 days
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.
Measured: Baseline / 60 days
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))
Measured: Baseline / 60 days
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).
Measured: Baseline / 60 days
Changes on muscle strength
Evaluation of muscle strength (kg)
Measured: Baseline / 30 days / 60 days
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).
Measured: Baseline / 60 days
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.
Measured: Baseline / 60 days
Changes on blood pressure
Evaluation of systolic and diastolic pressure (mm/Hg)
Measured: Baseline / 60 days
Changes on plasma free essential amino acids
Evaluation of free essential amino acids in plasma (Leucine, Isoleucine, Valine) (micromol/L)
Measured: Baseline / 60 days
Changes on safety parameters
Evaluation of creatinine (mg/dl)
Measured: Baseline / 60 days
Changes on safety parameters
Evaluation of alanine aminotransferase and aspartate aminotransferase (IU/L)
Measured: Baseline / 60 days
Changes on safety parameters
Evaluation of gamma glutamyl transferase (U/L)
Measured: Baseline / 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start22 Jan 2021
- Primary completion30 Jan 2021
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda di Servizi alla Persona di Pavia
- Sponsor type
- University, hospital or other
- Collaborators
- Abiogen Pharma
- Responsible party
- Sponsor
- Investigators
- Mariangela Rondanelli, Principal investigator, Fondazione Casemiro Mondino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04702087
- Sponsor's protocol ID
- 202000070742
- Status last verified
- Sep 2021
- First submitted
- 5 Jan 2021
- Last updated
- 5 Oct 2021
- Results posted
- 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 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04702087
- Acronym / sponsor ID
- 202000070742
- Conditions
- Sarcopenia, Elderly, Omega 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Azienda di Servizi alla Persona di PaviaUniversity, hospital or other
- Collaborators
- Abiogen Pharma
- Study start
- 22 Jan 2021 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- Dec 2022 (estimated)
- First posted
- 8 Jan 2021 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OLEP | Experimental | Dietary Supplement: OLEPOmega 3 (500 mg), leucine (2,5 g), probiotic Lactobacillus paracasei PS23 |
| Placebo | Placebo comparator | Combination Product: Placeboisocaloric formula |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Sarcopenic patients (diagnosis made according to the criteria Revised European Consensus on Definition and Diagnosis)
- Body Mass Index between 20 and 30 Kg/m2
Key exclusion criteria (10 listed)
- 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)
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 |
|---|---|---|
| OLEPomega 3 (500 mg), leucine (2,5 g), probiotic Lactobacillus paracasei PS23 | Dietary supplement | OLEP |
| PlaceboIsocaloric formula | Combination product | Placebo |
Primary outcome
Changes on muscle mass
Time frame: Baseline / 30 days / 60 days
Evaluation of fat free mass (g)
13 secondary outcomes
Changes on body composition
Time frame: Baseline / 30 days / 60 days
Changes on physical performancy
Time frame: Baseline / 60 days
Changes on physical performancy
Time frame: Baseline / 60 days
Changes on functional status
Time frame: Baseline / 60 days
Changes on functional status
Time frame: Baseline / 60 days
Changes on muscle strength
Time frame: Baseline / 30 days / 60 days
Changes on Quality of life
Time frame: Baseline / 60 days
Changes on mood
Time frame: Baseline / 60 days
Changes on blood pressure
Time frame: Baseline / 60 days
Changes on plasma free essential amino acids
Time frame: Baseline / 60 days
Changes on safety parameters
Time frame: Baseline / 60 days
Changes on safety parameters
Time frame: Baseline / 60 days
Changes on safety parameters
Time frame: Baseline / 60 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2021.
- 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.
Mariangela Rondanelli principal investigator
Fondazione Casemiro Mondino
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OLEP in people with Sarcopenia and Elderly, run by Azienda di Servizi alla Persona di Pavia 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 2 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 5 Oct 2021. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mariangela Rondanelli (+390382381749, mariangela.rondanelli@unipv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes on muscle mass (time frame: Baseline / 30 days / 60 days). 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 5 Oct 2021.