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

NCT04861857 | Unknown

• 1 other identifier: PaRMA.2
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrophy, Muscular; Aging; Inflammation; Cholesterol Deposition

Outcome Measures

Primary Outcomes (1)

• Leg lean Mass

  kg of lean mass measured via DEXA

  Change from baseline to up to 12 weeks

Secondary Outcomes (2)

• inflammatory marker: IL-6

  Change from baseline to up to 12 weeks

• cholesterol

  Change from baseline to up to 12 weeks

Study Arms (2)

Parmigiano Reggiano

EXPERIMENTAL

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

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

Dietary Supplement: Whey Protein

Interventions

Parmigiano Reggiano DIETARY_SUPPLEMENT

subjects will receive 50 g/die of the dietary supplement

Parmigiano Reggiano

Whey Protein DIETARY_SUPPLEMENT

subjects will receive 20 g/die of the dietary supplement

Whey Protein

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Padova: lead

Study Sites (1)

Nutrition and Exercise Lab, DSB, University of Padova

Padua, 35131, Italy

Location

MeSH Terms

Conditions

Muscular Atrophy; Inflammation

Interventions

Whey Proteins

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Proteins; Amino Acids, Peptides, and Proteins; Whey; Milk; Dairy Products; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Tatiana Moro, PhD

CONTACT

0498275306; tatiana.moro@unipd.it

Antonip Paoli, MD

CONTACT

049825318; antonio.paoli@unipd.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2021
• First Posted: April 27, 2021
• Study Start: May 1, 2021
• Primary Completion: March 31, 2022
• Study Completion: August 31, 2022
• Last Updated: May 5, 2021

Record last verified: 2021-01

Locations

IT (1)