Ignite Creation Date:
2025-12-24 @ 1:57 PM
Ignite Modification Date:
2025-12-28 @ 5:03 PM
Study NCT ID:
NCT03784495
Status:
COMPLETED
Last Update Posted:
2018-12-24
First Post:
2018-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Melatonin Plus Aminoacids for Sarcopenic Elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055948', 'term': 'Sarcopenia'}], 'ancestors': [{'id': 'D009133', 'term': 'Muscular Atrophy'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008550', 'term': 'Melatonin'}], 'ancestors': [{'id': 'D014363', 'term': 'Tryptamines'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 159}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2015-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-21', 'studyFirstSubmitDate': '2018-12-14', 'studyFirstSubmitQcDate': '2018-12-21', 'lastUpdatePostDateStruct': {'date': '2018-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Total Fat Mass and Total Free Fat Mass (DXA)', 'timeFrame': '0, 30 days', 'description': 'Body composition by dual-energy X-ray absorptiometry (DXA). Body composition was measured by DXA, using a Lunar Prodigy DXA (GE Medical Systems, Waukesha, WI). Free Fat mass and Fat mass of specific body regions were measured in kilograms.'}, {'measure': 'Change in Handgrip Strenght', 'timeFrame': '0, 30 days', 'description': 'Handgrip strength assessed using a Jamar dynamometer adhering to the standardized protocol recommended by the American Society of Hand Therapists. A weak handgrip was defined as \\<30 kg for men and \\<20 kg for women, based on the average value of the two handgrip measurements of the dominant hand'}], 'secondaryOutcomes': [{'measure': 'Height', 'timeFrame': 'At baseline (0)', 'description': 'Height measured in meters'}, {'measure': 'Change in Body Weight', 'timeFrame': '0, 30 days', 'description': 'Body Weight measured in kilograms'}, {'measure': 'Change in serum proteins', 'timeFrame': '0, 30 days', 'description': 'Serum proteins and albumin were measured by automatic biochemical analyzer. They were reported as g/dl'}, {'measure': 'Change in blood lipids (total cholesterol and triglycerides)', 'timeFrame': '0, 30 days', 'description': 'Blood lipids (total cholesterol and triglycerides)were measured by automatic biochemical analyzer. They were reported as mg/dl'}, {'measure': 'Change in High-sensitivity C-reactive protein (CRP)', 'timeFrame': '0, 30 days', 'description': 'High-sensitivity C-reactive protein (CRP) was expressed in mg/dl.'}, {'measure': 'Change in erythrocyte sedimentation rate (ESR)', 'timeFrame': '0, 30 days', 'description': 'Erythrocyte sedimentation rate (ESR) was expressed in mm/hr.'}, {'measure': 'Change in glycaemia', 'timeFrame': '0, 30 days', 'description': 'glycemia was expressed in mg/dl'}, {'measure': 'Change in Mini Nutritional Assessment (MNA)', 'timeFrame': '0, 30 days', 'description': 'A mini nutritional assessment (MNA) was performed for all participants. The MNA uses 18 questions regarding simple measurements and a brief questionnaire involving an anthropometric assessment (weight, height and weight loss), a general assessment (lifestyle, medication and mobility), and a dietary assessment (number of meals, food and fluid intake, self-assessment of eating autonomy and self-perception of health and nutrition). Every answer give up to a maximum of 3 points. The sum of all points gives the total MNA. A maximum of 30 points can be achieved. A score of ≥ 24 points describes a well-nourished status. A score of 17 to 23.5 points indicates a risk of malnutrition, while less than 17 points indicates malnutrition.'}, {'measure': 'Change in dietary intake', 'timeFrame': 'Measures taken at day 1,2,3 and at day 28,29,30', 'description': 'A trained dietitian used a calibrated dietetic spring scale to weigh all foods served and returned for 3 consecutive days at the beginning and end of the study'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sarcopenia']}, 'descriptionModule': {'briefSummary': 'To evaluate the effectiveness of melatonin and essential aminoacid supplementation on body composition, protein metabolism, strength and inflammation. The investigators performed a Randomized controlled parallel groups preliminary trial in 159 elderly sarcopenic people (42/117 men/women) assigned to 4 groups: isocaloric placebo (P, n=44), melatonin (M, 1 mg/daily, n=42,), essential aminoacids (eAA 4 g/daily, n=40) or eAA plus melatonin (eAAM, 4 g eAA and 1 mg melatonin/daily, n= 30). The period of intervention was 4 weeks. Data from body composition (DXA), strength (handgrip test) and biochemical parameters for the assessment of protein metabolism (albumin) and inflammation (PRC) were collected at baseline and after the 4-week intervention'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged \\> or equal 65 years\n* Sarcopenic patients, following the Rosetta Study criteria: Skeletal Muscle Index \\[SMI\\] was \\<7.23 kg/m2 in men and \\<5.45 kg/m2 in women) and loss of strength, evaluated by dynamometer and defined as \\<30 kg for men and \\<20 kg for women, using the average value of the two handgrip measurements of the dominant hand.\n\nExclusion Criteria:\n\n* acute illnesses\n* severe liver dysfunction\n* severe heart dysfunction\n* severe kidney dysfunction\n* severe dementia\n* uncontrolled diabetes\n* dysthyroidism\n* any endocrinopathies\n* neoplasia\n* patients treated with steroids\n* patients entirely unable to walk'}, 'identificationModule': {'nctId': 'NCT03784495', 'acronym': 'MelAASarc', 'briefTitle': 'Melatonin Plus Aminoacids for Sarcopenic Elderly', 'organization': {'class': 'OTHER', 'fullName': 'Azienda di Servizi alla Persona di Pavia'}, 'officialTitle': 'Is a Combination of Melatonin and Aminoacids Useful to Sarcopenic Elderly Patients? A Randomized Trial', 'orgStudyIdInfo': {'id': '1215/11122015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (P)', 'description': 'Placebo.', 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Melatonin (M)', 'description': '1 mg/day of melatonin.', 'interventionNames': ['Drug: Melatonin 1mg']}, {'type': 'EXPERIMENTAL', 'label': 'Essential Aminoacids (eAA)', 'description': '4 g/day of essential aminoacids', 'interventionNames': ['Dietary Supplement: Essential Aminoacids (eAA)']}, {'type': 'EXPERIMENTAL', 'label': 'Essential Aminoacids + Melatonin (eAAM)', 'description': '4 g/day of essential aminoacids and 1 mg/day of melatonin', 'interventionNames': ['Combination Product: Essential Aminoacids + melatonin']}], 'interventions': [{'name': 'Melatonin 1mg', 'type': 'DRUG', 'description': '1 mg/day 30 minutes before sleep', 'armGroupLabels': ['Melatonin (M)']}, {'name': 'Essential Aminoacids (eAA)', 'type': 'DIETARY_SUPPLEMENT', 'description': '4g/day of Essential Aminoacids during breakfast. Packets of powdered amino acid supplements (42.0% leucine, 14.0% lysine, 10.5% valine, 10.5% isoleucine, 10.5% threonine, 7.0% phenylalanine, and 5.5% other) were provided for the participants to be taken with water or milk, and they were instructed to take the 4-gram supplement once a day every day for 4 weeks.', 'armGroupLabels': ['Essential Aminoacids (eAA)']}, {'name': 'Essential Aminoacids + melatonin', 'type': 'COMBINATION_PRODUCT', 'description': '4g/day of Essential Aminoacids during breakfast + 1 mg/day of Melatonin 30 minutes before sleep. Packets of powdered amino acid supplements (42.0% leucine, 14.0% lysine, 10.5% valine, 10.5% isoleucine, 10.5% threonine, 7.0% phenylalanine, and 5.5% other) were provided for the participants to be taken with water or milk, and they were instructed to take the 4-gram supplement once a day every day for 4 weeks.', 'armGroupLabels': ['Essential Aminoacids + Melatonin (eAAM)']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'an isocaloric amount of maltodextrin with the same flavor and appearance as the intervention product', 'armGroupLabels': ['Placebo (P)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27100', 'city': 'Pavia', 'country': 'Italy', 'facility': 'Geriatric physical medicine and rehabilitation division at the Istituto Santa Margherita - Azienda di Servizi alla Persona di Pavia', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}], 'overallOfficials': [{'name': 'Mariangela Rondanelli, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'IRCCS Mondino Foundation, Pavia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD will be not available for other researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda di Servizi alla Persona di Pavia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Associate Professor', 'investigatorFullName': 'Mariangela Rondanelli', 'investigatorAffiliation': 'Azienda di Servizi alla Persona di Pavia'}}}}