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

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.

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 Overview

• Status: Unknown
• Conditions: Inflammation; Aging; Atrophy, Muscular; Cholesterol Deposition
• Intervention / Treatment: Dietary supplement: Parmigiano Reggiano; Dietary supplement: Whey Protein

• Study Type: Interventional
• Enrollment (Anticipated): 24
• 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: 60 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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:

• 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: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; subjects will receive 50 g/die of the dietary supplement
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; subjects will receive 20 g/die of the dietary supplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Leg lean Mass	kg of lean mass measured via DEXA	Change from baseline to up to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
inflammatory marker: IL-6	levels of plasma IL-6 (mg/dL)	Change from baseline to up to 12 weeks
cholesterol	levels of plasma cholesterol (mg/dL)	Change from baseline to up to 12 weeks

Collaborators and Investigators

• Sponsor: University of Padova

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): May 1, 2021
• Primary Completion (ANTICIPATED): March 31, 2022
• Study Completion (ANTICIPATED): August 31, 2022

Study Registration Dates

• First Submitted: April 23, 2021
• First Submitted That Met QC Criteria: April 23, 2021
• First Posted (ACTUAL): April 27, 2021

Study Record Updates

• Last Update Posted (ACTUAL): May 5, 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: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Atrophy; Inflammation; Muscular Atrophy
• Other Study ID Numbers: PaRMA.2

Drug and device information, study documents

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