Atrophy, MuscularNCT04861857
Effects of Parmigiano Reggiano on Muscle and Inflammatory Response to Eccentric Resistance Training in Older Adults
A study testing Parmigiano Reggiano and Whey Protein in people with Atrophy, Muscular and Aging, run by University of Padova at 1 site in Italy.
Trial summary
Aging is associated with the loss of muscle mass and function (sarcopenia) and reduced tissue regenerative capacity. Eccentric exercise (ECC) is a model of RET that can be used with the elderly, due to the ability of the muscle to combine high muscle strength production with low energy cost. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrophy, Muscular, Aging, Inflammation
- What is being tested?
- Parmigiano Reggiano and Whey Protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2021to 31 Aug 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age >60 years
- BMI >18 and <30 kg/m2
- stable body weight in the past 3 months
- valid medical certifacate for practice of physical activity
Who cannot join
- diabetes or pre-diabetes as for ADA guidelines
- chronic diseases (cardiovascular, liver, respiratory, cancer, etc)
- acute inflammatory status
- regular practice of intense physical activity (>2 sessions/week)
- treatment with steroids in the past 3 months
- regular use of >50g/die of Parmigiano Reggiano
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Parmigiano Reggiano on Muscle and Inflammatory Response to 12 Weeks of Eccentric Resistance Training in Older Adults
Aging is associated with the loss of muscle mass and function (sarcopenia) and reduced tissue regenerative capacity.
Eccentric exercise (ECC) is a model of RET that can be used with the elderly, due to the ability of the muscle to combine high muscle strength production with low energy cost. ECC contractions are significantly more damaging to the muscles and produce greater muscle strength, for these reasons there is a greater risk of inducing muscle damage before the muscle is able to adapt.
Read more
Parmigiano Reggiano (PR) has some peculiar bromatological characteristics. The proteins contained in it, and in particular the potentially bioactive peptide sequences, can rapidly provide the amino acids necessary to promote muscle growth and repair during exercise. Furthermore, PR can be an important source of fatty acids, of which a significant amount of short-chain fatty acids (SCFA) which are known to have important clinical effects on body composition and metabolic health and can have a systemic anti-inflammatory effect.
Therefore, the central hypothesize is that PR consumed while being engaged in a RET can provide more energy substrates and improve muscle recovery, redcue inflammatory markers and improve lipid metabolism. To date, no studies have studied its function on recovery from exercise nor in the elderly.
- Conditions
- Atrophy, Muscular, Aging, Inflammation, Cholesterol Deposition
- Being tested
- Parmigiano Reggiano, Whey Protein
- Medical subject headings
- Muscular Atrophy, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parmigiano ReggianoDietary supplement
subjects will receive 50 g/die of the dietary supplement
Whey ProteinDietary supplement
subjects will receive 20 g/die of the dietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Parmigiano Reggiano | Experimental | participants will consume 50 g/die of the dietary supplement and undergo to eccentric exercise training 3 times/week Receives: Dietary Supplement: Parmigiano Reggiano |
| Whey Protein | Active comparator | participants will consume 20 g/die of the dietary supplement and undergo to eccentric exercise training 3 times/week Receives: Dietary Supplement: Whey Protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leg lean Mass
kg of lean mass measured via DEXA
Measured: Change from baseline to up to 12 weeks
Secondary outcomes (2)
inflammatory marker: IL-6
levels of plasma IL-6 (mg/dL)
Measured: Change from baseline to up to 12 weeks
cholesterol
levels of plasma cholesterol (mg/dL)
Measured: Change from baseline to up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start1 May 2021 (estimated)
- Primary completion31 Mar 2022 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrophy, MuscularStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04861857
- Sponsor's protocol ID
- PaRMA.2
- Status last verified
- Jan 2021
- First submitted
- 23 Apr 2021
- Last updated
- 5 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Parmigiano Reggiano on Muscle and Inflammatory Response to 12 Weeks of Eccentric Resistance Training in Older Adults
- ClinicalTrials.gov ID
- NCT04861857
- Acronym / sponsor ID
- PaRMA.2
- Conditions
- Atrophy, Muscular, Aging, Inflammation, Cholesterol Deposition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 1 May 2021 (estimated)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 27 Apr 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.
Aging is associated with the loss of muscle mass and function (sarcopenia) and reduced tissue regenerative capacity.
Eccentric exercise (ECC) is a model of RET that can be used with the elderly, due to the ability of the muscle to combine high muscle strength production with low energy cost. ECC contractions are significantly more damaging to the muscles and produce greater muscle strength, for these reasons there is a greater risk of inducing muscle damage before the muscle is able to adapt.
Parmigiano Reggiano (PR) has some peculiar bromatological characteristics. The proteins contained in it, and in particular the potentially bioactive peptide sequences, can rapidly provide the amino acids necessary to promote muscle growth and repair during exercise. Furthermore, PR can be an important source of fatty acids, of which a significant amount of short-chain fatty acids (SCFA) which are known to have important clinical effects on body composition and metabolic health and can have a systemic anti-inflammatory effect.
Therefore, the central hypothesize is that PR consumed while being engaged in a RET can provide more energy substrates and improve muscle recovery, redcue inflammatory markers and improve lipid metabolism. To date, no studies have studied its function on recovery from exercise nor in the elderly.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parmigiano Reggiano | Experimental | Dietary Supplement: Parmigiano Reggianoparticipants will consume 50 g/die of the dietary supplement and undergo to eccentric exercise training 3 times/week |
| Whey Protein | Active comparator | Dietary Supplement: Whey Proteinparticipants will consume 20 g/die of the dietary supplement and undergo to eccentric exercise training 3 times/week |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age >60 years
- BMI >18 and <30 kg/m2
- stable body weight in the past 3 months
- valid medical certifacate for practice of physical activity
Key exclusion criteria (6 listed)
- diabetes or pre-diabetes as for ADA guidelines
- chronic diseases (cardiovascular, liver, respiratory, cancer, etc)
- acute inflammatory status
- regular practice of intense physical activity (>2 sessions/week)
- treatment with steroids in the past 3 months
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 |
|---|---|---|
| Parmigiano Reggianosubjects will receive 50 g/die of the dietary supplement | Dietary supplement | Parmigiano Reggiano |
| Whey Proteinsubjects will receive 20 g/die of the dietary supplement | Dietary supplement | Whey Protein |
Primary outcome
Leg lean Mass
Time frame: Change from baseline to up to 12 weeks
kg of lean mass measured via DEXA
2 secondary outcomes
inflammatory marker: IL-6
Time frame: Change from baseline to up to 12 weeks
cholesterol
Time frame: Change from baseline to up to 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parmigiano Reggiano and Whey Protein in people with Atrophy, Muscular and Aging, run by University of Padova 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 4 inclusion and 6 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 May 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. 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 Tatiana Moro, PhD (0498275306, tatiana.moro@unipd.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leg lean Mass (time frame: Change from baseline to up to 12 weeks). 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 May 2021.