Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2025-12-29 @ 11:21 PM
Study NCT ID:
NCT04861857
Status:
UNKNOWN
Last Update Posted:
2021-05-05
First Post:
2021-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Parmigiano Reggiano on Muscle and Inflammatory Response to Eccentric Resistance Training in Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000067816', 'term': 'Whey Proteins'}], 'ancestors': [{'id': 'D008894', 'term': 'Milk Proteins'}, {'id': 'D000080224', 'term': 'Animal Proteins, Dietary'}, {'id': 'D004044', 'term': 'Dietary Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000067796', 'term': 'Whey'}, {'id': 'D008892', 'term': 'Milk'}, {'id': 'D003611', 'term': 'Dairy Products'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2022-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-29', 'studyFirstSubmitDate': '2021-04-23', 'studyFirstSubmitQcDate': '2021-04-23', 'lastUpdatePostDateStruct': {'date': '2021-05-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Leg lean Mass', 'timeFrame': 'Change from baseline to up to 12 weeks', 'description': 'kg of lean mass measured via DEXA'}], 'secondaryOutcomes': [{'measure': 'inflammatory marker: IL-6', 'timeFrame': 'Change from baseline to up to 12 weeks', 'description': 'levels of plasma IL-6 (mg/dL)'}, {'measure': 'cholesterol', 'timeFrame': 'Change from baseline to up to 12 weeks', 'description': 'levels of plasma cholesterol (mg/dL)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atrophy, Muscular', 'Aging', 'Inflammation', 'Cholesterol Deposition']}, 'descriptionModule': {'briefSummary': 'Aging is associated with the loss of muscle mass and function (sarcopenia) and reduced tissue regenerative capacity.\n\nEccentric 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.\n\nParmigiano 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.\n\nTherefore, 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\>60 years\n* BMI \\>18 and \\<30 kg/m2\n* stable body weight in the past 3 months\n* valid medical certifacate for practice of physical activity\n\nExclusion Criteria:\n\n* diabetes or pre-diabetes as for ADA guidelines\n* chronic diseases (cardiovascular, liver, respiratory, cancer, etc)\n* acute inflammatory status\n* regular practice of intense physical activity (\\>2 sessions/week)\n* treatment with steroids in the past 3 months\n* regular use of \\>50g/die of Parmigiano Reggiano'}, 'identificationModule': {'nctId': 'NCT04861857', 'briefTitle': 'Effects of Parmigiano Reggiano on Muscle and Inflammatory Response to Eccentric Resistance Training in Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'University of Padova'}, 'officialTitle': 'Effects of Parmigiano Reggiano on Muscle and Inflammatory Response to 12 Weeks of Eccentric Resistance Training in Older Adults', 'orgStudyIdInfo': {'id': 'PaRMA.2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Parmigiano Reggiano', 'description': 'participants will consume 50 g/die of the dietary supplement and undergo to eccentric exercise training 3 times/week', 'interventionNames': ['Dietary Supplement: Parmigiano Reggiano']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Whey Protein', 'description': 'participants will consume 20 g/die of the dietary supplement and undergo to eccentric exercise training 3 times/week', 'interventionNames': ['Dietary Supplement: Whey Protein']}], 'interventions': [{'name': 'Parmigiano Reggiano', 'type': 'DIETARY_SUPPLEMENT', 'description': 'subjects will receive 50 g/die of the dietary supplement', 'armGroupLabels': ['Parmigiano Reggiano']}, {'name': 'Whey Protein', 'type': 'DIETARY_SUPPLEMENT', 'description': 'subjects will receive 20 g/die of the dietary supplement', 'armGroupLabels': ['Whey Protein']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35131', 'city': 'Padua', 'country': 'Italy', 'facility': 'Nutrition and Exercise Lab, DSB, University of Padova', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}], 'centralContacts': [{'name': 'Tatiana Moro, PhD', 'role': 'CONTACT', 'email': 'tatiana.moro@unipd.it', 'phone': '0498275306'}, {'name': 'Antonip Paoli, MD', 'role': 'CONTACT', 'email': 'antonio.paoli@unipd.it', 'phone': '049825318'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Padova', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}