CClinicalTrials.gg
Status unknownNCT04872374Updated May 4, 2021

Effects of Parmigiano Reggiano on Skeletal Muscle Damage in Older Adults

An interventional study of Parmigiano Reggiano and Whey Protein in Old Age; Atrophy, Inflammatory Response and Muscle Soreness, sponsored by University of Padova. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-04.

Sponsored by University of Padova · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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 hypothes is that PR consumed during RET can provide more energy substrates and improve muscle recovery. To date, no studies have studied its function on recovery from exercise nor in the elderly.

02

Conditions studied

  • Old Age; Atrophy
  • Inflammatory Response
  • Muscle Soreness

Browse trials for

03

In context

Myalgia

282 studies on the registry are indexed under Myalgia; 43 are open to participants now.

This study's planned enrollment of 20 is below the median of 44 across 241 interventional studies indexed under Myalgia.

Browse Myalgia studies →

Lead sponsor

University of Padova is the lead sponsor of 210 studies on the registry; 42 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • age >60 years old or >18 and \< 30 years old
  • BMI >18 and \<30 kg/m2
  • stable body weight in the past 3 months
  • valid medical certifacate for practice of physical activity

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Young adults

    participants will perform an eccentric exercise bout after 10 days of dietary supplementation

    Dietary Supplement: Parmigiano Reggiano · Dietary Supplement: Whey Protein

  • Active comparator
    Older adults

    participants will perform an eccentric exercise bout after 10 days of dietary supplementation

    Dietary Supplement: Parmigiano Reggiano · Dietary Supplement: Whey Protein

Interventions

  • Dietary supplementParmigiano Reggiano

    subjects will receive 50 g/die of the dietary supplement 10 days before performing the eccentric exercise session

  • Dietary supplementWhey Protein

    subjects will receive 20 g/die of the dietary supplement 10 days before performing the eccentric exercise session

06

What researchers measure

Primary outcomes

  1. maximum volountary contraction (MVC)

    maximal muscle volountary contraction mesured in Newton

    Time frame: Change from baseline to up to 5 days

Secondary outcomes

  1. reactive Proteinc C

    plasmatic levels of reactive Proteinc C (mg/dL) as a markers of muscle damage

    Time frame: Change from baseline to up to 5 days

  2. Creatin Kinase

    plasmatic levels of Creatin Kinase (mmol/dL) as a markers of muscle damage

    Time frame: Change from baseline to up to 5 days

  3. IL-6

    plasmatic levels of IL-6 (mg/dL) as a markers of muscle damage

    Time frame: Change from baseline to up to 5 days

  4. delayed onset muscle soreness (DOMS)

    level of delayed onset muscle soreness (DOMS) masured via Visual Analogue Scale (VAS) scale where 0 is the minimal value (no pain) and 10 is the maximum value (maximum pain).

    Time frame: Change from baseline to up to 5 days

07

Study locations

1 site
  • Nutrition and Exercise Lab, DSB, University of Padova
    Padova, 35131, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04872374
Lead sponsor
University of Padova
Responsible party
Sponsor
First posted
May 4, 2021
Start date
May 1, 2021 (estimated)
Primary completion
Oct 31, 2021 (estimated)
Completion
Mar 1, 2022 (estimated)
Last update
May 4, 2021

Study contacts

Tatiana Moro, PhD
Contact
tatiana.moro@unipd.it
0498275306
Antonip Paoli, MD
Contact
antonio.paoli@unipd.it
049825318

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion