Effects of Parmigiano Reggiano on Skeletal Muscle Damage in Older Adults

Inflammatory Response Clinical Trial

Official title:

Effects of Parmigiano Reggiano on Exercise Induced Muscle Damage in Older Adults

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04872374
• Other study ID #: PaRMA.1
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: March 1, 2022

Study information

• Verified date: January 2021
• Source: University of Padova
• Contact: Tatiana Moro, PhD
• Phone: 0498275306
• Email: tatiana.moro[@]unipd.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: March 1, 2022
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Inflammatory Response
• Muscle Soreness
• Myalgia
• Old Age; Atrophy

Intervention

Dietary Supplement:
• Parmigiano Reggiano
subjects will receive 50 g/die of the dietary supplement 10 days before performing the eccentric exercise session
• Whey Protein
subjects will receive 20 g/die of the dietary supplement 10 days before performing the eccentric exercise session

Locations

Country	Name	City	State
Italy	Nutrition and Exercise Lab, DSB, University of Padova	Padova

Sponsors (1)

Lead Sponsor	Collaborator
University of Padova

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	maximum volountary contraction (MVC)	maximal muscle volountary contraction mesured in Newton	Change from baseline to up to 5 days
Secondary	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
Secondary	Creatin Kinase	plasmatic levels of Creatin Kinase (mmol/dL) as a markers of muscle damage	Change from baseline to up to 5 days
Secondary	IL-6	plasmatic levels of IL-6 (mg/dL) as a markers of muscle damage	Change from baseline to up to 5 days
Secondary	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