Back to results

Effects of Parmigiano Reggiano on Skeletal Muscle Damage in Older Adults

Primary Purpose

Old Age; Atrophy, Inflammatory Response, Muscle Soreness

Status

Unknown status

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Parmigiano Reggiano

Whey Protein

About this trial

This is an interventional treatment trial for Old Age; Atrophy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Nutrition and Exercise Lab, DSB, University of Padova

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Young adults

Older adults

Arm Description

participants will perform an eccentric exercise bout after 10 days of dietary supplementation

Outcomes

Primary Outcome Measures

maximum volountary contraction (MVC)

maximal muscle volountary contraction mesured in Newton

Secondary Outcome Measures

reactive Proteinc C

plasmatic levels of reactive Proteinc C (mg/dL) as a markers of muscle damage

Creatin Kinase

plasmatic levels of Creatin Kinase (mmol/dL) as a markers of muscle damage

IL-6

plasmatic levels of IL-6 (mg/dL) as a markers of muscle damage

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).

Full Information

NCT ID

NCT04872374

First Posted

April 23, 2021

Last Updated

April 29, 2021

Sponsor

University of Padova

1. Study Identification

Unique Protocol Identification Number

NCT04872374

Brief Title

Effects of Parmigiano Reggiano on Skeletal Muscle Damage in Older Adults

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Unknown status

Study Start Date

May 1, 2021 (Anticipated)

Primary Completion Date

October 31, 2021 (Anticipated)

Study Completion Date

March 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Padova

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Old Age; Atrophy, Inflammatory Response, Muscle Soreness

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Young adults

Arm Type

Experimental

Arm Description

participants will perform an eccentric exercise bout after 10 days of dietary supplementation

Arm Title

Older adults

Arm Type

Active Comparator

Arm Description

participants will perform an eccentric exercise bout after 10 days of dietary supplementation

Intervention Type

Dietary Supplement

Intervention Name(s)

Parmigiano Reggiano

Intervention Description

subjects will receive 50 g/die of the dietary supplement 10 days before performing the eccentric exercise session

Intervention Type

Dietary Supplement

Intervention Name(s)

Whey Protein

Intervention Description

subjects will receive 20 g/die of the dietary supplement 10 days before performing the eccentric exercise session

Primary Outcome Measure Information:

Title

maximum volountary contraction (MVC)

Description

maximal muscle volountary contraction mesured in Newton

Time Frame

Change from baseline to up to 5 days

Secondary Outcome Measure Information:

Title

reactive Proteinc C

Description

plasmatic levels of reactive Proteinc C (mg/dL) as a markers of muscle damage

Time Frame

Change from baseline to up to 5 days

Title

Creatin Kinase

Description

plasmatic levels of Creatin Kinase (mmol/dL) as a markers of muscle damage

Time Frame

Change from baseline to up to 5 days

Title

IL-6

Description

plasmatic levels of IL-6 (mg/dL) as a markers of muscle damage

Time Frame

Change from baseline to up to 5 days

Title

delayed onset muscle soreness (DOMS)

Description

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).

Time Frame

Change from baseline to up to 5 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Tatiana Moro, PhD

Phone

0498275306

tatiana.moro@unipd.it

First Name & Middle Initial & Last Name or Official Title & Degree

Antonip Paoli, MD

Phone

049825318

antonio.paoli@unipd.it

Facility Information:

Facility Name

Nutrition and Exercise Lab, DSB, University of Padova

City

Padova

ZIP/Postal Code

35131

Country

Italy

12. IPD Sharing Statement

Learn more about this trial

Effects of Parmigiano Reggiano on Skeletal Muscle Damage in Older Adults

We'll reach out to this number within 24 hrs