NCT04872374

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2021

Completed
8 days until next milestone

Study Start

First participant enrolled

May 1, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 4, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

May 4, 2021

Status Verified

January 1, 2021

Enrollment Period

6 months

First QC Date

April 23, 2021

Last Update Submit

April 29, 2021

Conditions

Old Age; AtrophyInflammatory ResponseMuscle Soreness

Outcome Measures

Primary Outcomes (1)

  • maximum volountary contraction (MVC)

    maximal muscle volountary contraction mesured in Newton

    Change from baseline to up to 5 days

Secondary Outcomes (4)

  • reactive Proteinc C

    Change from baseline to up to 5 days

  • Creatin Kinase

    Change from baseline to up to 5 days

  • IL-6

    Change from baseline to up to 5 days

  • delayed onset muscle soreness (DOMS)

    Change from baseline to up to 5 days

Study Arms (2)

Young adults

EXPERIMENTAL

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

Dietary Supplement: Parmigiano ReggianoDietary Supplement: Whey Protein

Older adults

ACTIVE COMPARATOR

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

Dietary Supplement: Parmigiano ReggianoDietary Supplement: Whey Protein

Interventions

Parmigiano ReggianoDIETARY_SUPPLEMENT

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

Older adultsYoung adults
Whey ProteinDIETARY_SUPPLEMENT

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

Older adultsYoung adults

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nutrition and Exercise Lab, DSB, University of Padova

Padua, 35131, Italy

Location

MeSH Terms

Conditions

AtrophyMyalgia

Interventions

Whey Proteins

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesMusculoskeletal PainPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Milk ProteinsAnimal Proteins, DietaryDietary ProteinsProteinsAmino Acids, Peptides, and ProteinsWheyMilkDairy ProductsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Central Study Contacts

Tatiana Moro, PhD

CONTACT

0498275306tatiana.moro@unipd.it

Antonip Paoli, MD

CONTACT

049825318antonio.paoli@unipd.it

Study Design

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

Study Record Dates

First Submitted

April 23, 2021

First Posted

May 4, 2021

Study Start

May 1, 2021

Primary Completion

October 31, 2021

Study Completion

March 1, 2022

Last Updated

May 4, 2021

Record last verified: 2021-01

Locations

IT(1)