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

Primary Purpose

Atrophy, Muscular, Aging, Inflammation

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Parmigiano Reggiano
Whey Protein
Sponsored by
University of Padova
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrophy, Muscular

Eligibility Criteria

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

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

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

Parmigiano Reggiano

Whey Protein

Arm Description

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

participants will consume 20 g/die of the dietary supplement and undergo to eccentric exercise training 3 times/week

Outcomes

Primary Outcome Measures

Leg lean Mass
kg of lean mass measured via DEXA

Secondary Outcome Measures

inflammatory marker: IL-6
levels of plasma IL-6 (mg/dL)
cholesterol
levels of plasma cholesterol (mg/dL)

Full Information

First Posted
April 23, 2021
Last Updated
April 29, 2021
Sponsor
University of Padova
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1. Study Identification

Unique Protocol Identification Number
NCT04861857
Brief Title
Effects of Parmigiano Reggiano on Muscle and Inflammatory Response to Eccentric Resistance Training in Older Adults
Official Title
Effects of Parmigiano Reggiano on Muscle and Inflammatory Response to 12 Weeks of Eccentric Resistance Training 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
March 31, 2022 (Anticipated)
Study Completion Date
August 31, 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
No
Studies a U.S. FDA-regulated Device Product
No

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrophy, Muscular, Aging, Inflammation, Cholesterol Deposition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Parmigiano Reggiano
Arm Type
Experimental
Arm Description
participants will consume 50 g/die of the dietary supplement and undergo to eccentric exercise training 3 times/week
Arm Title
Whey Protein
Arm Type
Active Comparator
Arm Description
participants will consume 20 g/die of the dietary supplement and undergo to eccentric exercise training 3 times/week
Intervention Type
Dietary Supplement
Intervention Name(s)
Parmigiano Reggiano
Intervention Description
subjects will receive 50 g/die of the dietary supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
Whey Protein
Intervention Description
subjects will receive 20 g/die of the dietary supplement
Primary Outcome Measure Information:
Title
Leg lean Mass
Description
kg of lean mass measured via DEXA
Time Frame
Change from baseline to up to 12 weeks
Secondary Outcome Measure Information:
Title
inflammatory marker: IL-6
Description
levels of plasma IL-6 (mg/dL)
Time Frame
Change from baseline to up to 12 weeks
Title
cholesterol
Description
levels of plasma cholesterol (mg/dL)
Time Frame
Change from baseline to up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tatiana Moro, PhD
Phone
0498275306
Email
tatiana.moro@unipd.it
First Name & Middle Initial & Last Name or Official Title & Degree
Antonip Paoli, MD
Phone
049825318
Email
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 Muscle and Inflammatory Response to Eccentric Resistance Training in Older Adults

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