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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04861857
Other study ID # PaRMA.2
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 1, 2021
Est. completion date August 31, 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
Health authority
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 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 24
Est. completion date August 31, 2022
Est. primary completion date March 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Parmigiano Reggiano
subjects will receive 50 g/die of the dietary supplement
Whey Protein
subjects will receive 20 g/die of the dietary supplement

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 Leg lean Mass kg of lean mass measured via DEXA Change from baseline to up to 12 weeks
Secondary inflammatory marker: IL-6 levels of plasma IL-6 (mg/dL) Change from baseline to up to 12 weeks
Secondary cholesterol levels of plasma cholesterol (mg/dL) Change from baseline to up to 12 weeks
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