Effects of Parmigiano Reggiano on Skeletal Muscle Damage in Older Adults

Effects of Parmigiano Reggiano on Exercise Induced Muscle Damage 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.

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.

Study Overview

• Status: Unknown
• Conditions: Inflammatory Response; Muscle Soreness; Old Age; Atrophy
• Intervention / Treatment: Dietary supplement: Parmigiano Reggiano; Dietary supplement: Whey Protein

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Young adults; participants will perform an eccentric exercise bout after 10 days of dietary supplementation	Dietary supplement: Parmigiano Reggiano; subjects will receive 50 g/die of the dietary supplement 10 days before performing the eccentric exercise session; Dietary supplement: Whey Protein; subjects will receive 20 g/die of the dietary supplement 10 days before performing the eccentric exercise session
Active Comparator: Older adults; participants will perform an eccentric exercise bout after 10 days of dietary supplementation	Dietary supplement: Parmigiano Reggiano; subjects will receive 50 g/die of the dietary supplement 10 days before performing the eccentric exercise session; Dietary supplement: Whey Protein; subjects will receive 20 g/die of the dietary supplement 10 days before performing the eccentric exercise session

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
maximum volountary contraction (MVC)	maximal muscle volountary contraction mesured in Newton	Change from baseline to up to 5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
reactive Proteinc C	plasmatic levels of reactive Proteinc C (mg/dL) as a markers of muscle damage	Change from baseline to up to 5 days
Creatin Kinase	plasmatic levels of Creatin Kinase (mmol/dL) as a markers of muscle damage	Change from baseline to up to 5 days
IL-6	plasmatic levels of IL-6 (mg/dL) as a markers of muscle damage	Change from baseline to up to 5 days
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).	Change from baseline to up to 5 days

Collaborators and Investigators

• Sponsor: University of Padova

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2021
• Primary Completion (Anticipated): October 31, 2021
• Study Completion (Anticipated): March 1, 2022

Study Registration Dates

• First Submitted: April 23, 2021
• First Submitted That Met QC Criteria: April 29, 2021
• First Posted (Actual): May 4, 2021

Study Record Updates

• Last Update Posted (Actual): May 4, 2021
• Last Update Submitted That Met QC Criteria: April 29, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Musculoskeletal Pain; Myalgia
• Other Study ID Numbers: PaRMA.1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No