CClinicalTrials.gg
Status unknownNCT04861857Updated May 5, 2021

Effects of Parmigiano Reggiano on Muscle and Inflammatory Response to Eccentric Resistance Training in Older Adults

An interventional study of Parmigiano Reggiano and Whey Protein in Atrophy, Muscular, Aging and Inflammation, sponsored by University of Padova. Status unknown at 1 site in Italy. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-05.

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verified this record recently (last verified Jan 2021), so the status shown — last known as Not yet recruiting — may be out of date.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
24
Allocation
Randomized
Ages
60 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 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.

02

Conditions studied

  • Atrophy, Muscular
  • Aging
  • Inflammation
  • Cholesterol Deposition
03

In context

Muscular Atrophy

494 studies on the registry are indexed under Muscular Atrophy; 94 are open to participants now.

This study's planned enrollment of 24 is below the median of 33 across 335 interventional studies indexed under Muscular Atrophy.

Browse Muscular Atrophy 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
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

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
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    Parmigiano Reggiano

    participants will consume 50 g/die of the dietary supplement and undergo to eccentric exercise training 3 times/week

    Dietary Supplement: Parmigiano Reggiano

  • Active comparator
    Whey Protein

    participants will consume 20 g/die of the dietary supplement and undergo to eccentric exercise training 3 times/week

    Dietary Supplement: Whey Protein

Interventions

  • Dietary supplementParmigiano Reggiano

    subjects will receive 50 g/die of the dietary supplement

  • Dietary supplementWhey Protein

    subjects will receive 20 g/die of the dietary supplement

06

What researchers measure

Primary outcomes

  1. Leg lean Mass

    kg of lean mass measured via DEXA

    Time frame: Change from baseline to up to 12 weeks

Secondary outcomes

  1. inflammatory marker: IL-6

    levels of plasma IL-6 (mg/dL)

    Time frame: Change from baseline to up to 12 weeks

  2. cholesterol

    levels of plasma cholesterol (mg/dL)

    Time frame: Change from baseline to up to 12 weeks

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 5, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04861857
Lead sponsor
University of Padova
Responsible party
Sponsor
First posted
Apr 27, 2021
Start date
May 1, 2021 (estimated)
Primary completion
Mar 31, 2022 (estimated)
Completion
Aug 31, 2022 (estimated)
Last update
May 5, 2021

Study contacts

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

Oversight

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.

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