Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:06 AM
Study NCT ID:
NCT07143305
Status:
COMPLETED
Last Update Posted:
2025-10-02
First Post:
2025-08-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Citrulline Malate Supplementation on Physical Function and Biochemical Parameters in Physically Active Older Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2020-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-26', 'studyFirstSubmitDate': '2025-08-08', 'studyFirstSubmitQcDate': '2025-08-19', 'lastUpdatePostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-04-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Handgrip strength', 'timeFrame': 'At baseline, immediately before the start of the supplementation protocol, and at the end of the six-week intervention period, within 24 hours of the final exercise session', 'description': 'Handgrip strength (kg) was assessed with a digital handheld dynamometer (JAMAR®, 0-90 kg; Performance Health, Warrenville, IL, USA), by standardised procedures.'}, {'measure': 'Cardiorespiratory', 'timeFrame': 'At baseline, immediately before the start of the supplementation protocol, and at the end of the six-week intervention period, within 24 hours of the final exercise session', 'description': 'Cardiorespiratory fitness was evaluated using the six-minute walk test (6MWT) on a standardised indoor 400-metre track.'}, {'measure': 'Gait speed', 'timeFrame': 'At baseline, immediately before the start of the supplementation protocol, and at the end of the six-week intervention period, within 24 hours of the final exercise session', 'description': 'Gait speed was measured over four metres using photoelectric timing gates. Participants began walking five metres before the start line to ensure a consistent pace throughout the timed section.'}, {'measure': 'Lower limb strength', 'timeFrame': 'At baseline, immediately before the start of the supplementation protocol, and at the end of the six-week intervention period, within 24 hours of the final exercise session', 'description': 'Lower limb strength was assessed using the Five Times Sit-to-Stand Test (5xSTS), which involved recording the time taken to rise from a 45 cm highchair five times as quickly as possible without using the arms for support.'}, {'measure': 'Balance', 'timeFrame': 'At baseline, immediately before the start of the supplementation protocol, and at the end of the six-week intervention period, within 24 hours of the final exercise session', 'description': 'Balance was assessed via static balance testing in three different stances, held for 10 seconds each: side-by-side, semi-tandem and tandem'}, {'measure': 'Frailty and global physical function', 'timeFrame': 'At baseline, immediately before the start of the supplementation protocol, and at the end of the six-week intervention period, within 24 hours of the final exercise session', 'description': 'Frailty and global physical function were evaluated using the Short Physical Performance Battery (SPPB), which incorporates tests of gait speed, balance, and the ability to rise from a chair. Based on the total score obtained in all tests (range from 0 to 10), participants are identified as having severe limitations (0-4), moderate limitations (4-6), mild limitations (7-9) and minimal limitations (10-12).'}, {'measure': 'High-density lipoprotein (HDL)', 'timeFrame': 'At baseline, immediately before the start of the supplementation protocol, and at the end of the six-week intervention period, within 24 hours of the final exercise session', 'description': "High-density lipoprotein (HDL) was evaluated to explore potential cardiovascular implications.\n\nVenous blood samples were collected under standardised conditions between 08:00 and 08:30 a.m., following a minimum of 12 hours' fasting and at least eight hours' rest overnight. All extractions were performed by a certified nurse at an accredited clinical laboratory (Det Norske Veritas, certification no. 18031, Spain). A total of 10 ml of serum was drawn into clot-activator tubes, centrifuged and stored at -20 °C until analysis. Meanwhile, 3-5 mL of plasma was collected in EDTA® tubes and refrigerated at 4 °C for subsequent processing. All analytical procedures were conducted using standardised and validated platforms. Haematological assessments were performed using the Coulter Counter MAX-M® system, while biochemical and hormonal analyses were conducted using the Architect 2000® analyser (Abbott Diagnostics)."}, {'measure': 'Creatine kinase', 'timeFrame': 'At baseline, immediately before the start of the supplementation protocol, and at the end of the six-week intervention period, within 24 hours of the final exercise session', 'description': "Creatine kinase was measured as an indicator of muscle damage.\n\nVenous blood samples were collected under standardised conditions between 08:00 and 08:30 a.m., following a minimum of 12 hours' fasting and at least eight hours' rest overnight. All extractions were performed by a certified nurse at an accredited clinical laboratory (Det Norske Veritas, certification no. 18031, Spain).\n\nA total of 10 ml of serum was drawn into clot-activator tubes, centrifuged and stored at -20 °C until analysis. Meanwhile, 3-5 mL of plasma was collected in EDTA® tubes and refrigerated at 4 °C for subsequent processing.\n\nAll analytical procedures were conducted using standardised and validated platforms. Haematological assessments were performed using the Coulter Counter MAX-M® system, while biochemical and hormonal analyses were conducted using the Architect 2000® analyser (Abbott Diagnostics)."}, {'measure': 'Liver enzyme activity', 'timeFrame': 'At baseline, immediately before the start of the supplementation protocol, and at the end of the six-week intervention period, within 24 hours of the final exercise session', 'description': "Liver enzyme activity was assessed via serum levels of aspartate aminotransferase (AST/GOT) and alanine aminotransferase (ALT/GPT).\n\nVenous blood samples were collected under standardised conditions between 08:00 and 08:30 a.m., following a minimum of 12 hours' fasting and at least eight hours' rest overnight. All extractions were performed by a certified nurse at an accredited clinical laboratory (Det Norske Veritas, certification no. 18031, Spain).\n\nA total of 10 ml of serum was drawn into clot-activator tubes, centrifuged and stored at -20 °C until analysis. Meanwhile, 3-5 mL of plasma was collected in EDTA® tubes and refrigerated at 4 °C for subsequent processing.\n\nAll analytical procedures were conducted using standardised and validated platforms. Haematological assessments were performed using the Coulter Counter MAX-M® system, while biochemical and hormonal analyses were conducted using the Architect 2000® analyser (Abbott Diagnostics)."}, {'measure': 'Low-density lipoprotein (LDL)', 'timeFrame': 'At baseline, immediately before the start of the supplementation protocol, and at the end of the six-week intervention period, within 24 hours of the final exercise session', 'description': "Low-density lipoprotein (HDL) was evaluated to explore potential cardiovascular implications.\n\nVenous blood samples were collected under standardised conditions between 08:00 and 08:30 a.m., following a minimum of 12 hours' fasting and at least eight hours' rest overnight. All extractions were performed by a certified nurse at an accredited clinical laboratory (Det Norske Veritas, certification no. 18031, Spain). A total of 10 ml of serum was drawn into clot-activator tubes, centrifuged and stored at -20 °C until analysis. Meanwhile, 3-5 mL of plasma was collected in EDTA® tubes and refrigerated at 4 °C for subsequent processing. All analytical procedures were conducted using standardised and validated platforms. Haematological assessments were performed using the Coulter Counter MAX-M® system, while biochemical and hormonal analyses were conducted using the Architect 2000® analyser (Abbott Diagnostics)."}, {'measure': 'Glucose', 'timeFrame': 'At baseline, immediately before the start of the supplementation protocol, and at the end of the six-week intervention period, within 24 hours of the final exercise session', 'description': "Glucose provided insight into metabolic regulation. Venous blood samples were collected under standardised conditions between 08:00 and 08:30 a.m., following a minimum of 12 hours' fasting and at least eight hours' rest overnight. All extractions were performed by a certified nurse at an accredited clinical laboratory (Det Norske Veritas, certification no. 18031, Spain). A total of 10 ml of serum was drawn into clot-activator tubes, centrifuged and stored at -20 °C until analysis. Meanwhile, 3-5 mL of plasma was collected in EDTA® tubes and refrigerated at 4 °C for subsequent processing. All analytical procedures were conducted using standardised and validated platforms. Haematological assessments were performed using the Coulter Counter MAX-M® system, while biochemical and hormonal analyses were conducted using the Architect 2000® analyser (Abbott Diagnostics)."}, {'measure': 'Testosterone', 'timeFrame': 'At baseline, immediately before the start of the supplementation protocol, and at the end of the six-week intervention period, within 24 hours of the final exercise session', 'description': "Testosterone was used to evaluate the hormonal status and potential anabolic-catabolic shifts.\n\nVenous blood samples were collected under standardised conditions between 08:00 and 08:30 a.m., following a minimum of 12 hours' fasting and at least eight hours' rest overnight. All extractions were performed by a certified nurse at an accredited clinical laboratory (Det Norske Veritas, certification no. 18031, Spain). A total of 10 ml of serum was drawn into clot-activator tubes, centrifuged and stored at -20 °C until analysis. Meanwhile, 3-5 mL of plasma was collected in EDTA® tubes and refrigerated at 4 °C for subsequent processing. All analytical procedures were conducted using standardised and validated platforms. Haematological assessments were performed using the Coulter Counter MAX-M® system, while biochemical and hormonal analyses were conducted using the Architect 2000® analyser (Abbott Diagnostics)."}], 'secondaryOutcomes': [{'measure': 'Quality of life questionnaire', 'timeFrame': 'At baseline, immediately before the start of the supplementation protocol, and at the end of the six-week intervention period, within 24 hours of the final exercise session', 'description': 'Quality of life was measured using the World Health Organization Quality of Life Questionnaire - Brief Version (WHOQOL-BREF). The scale ranges from 0 to 100. Higher scores indicate a higher quality of life.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['citrulline', 'Physical Performance', 'older women'], 'conditions': ['Supplementation']}, 'descriptionModule': {'briefSummary': 'A randomised, double-blind, placebo-controlled pilot trial was conducted with thirty-three community-dwelling women aged 65 years or over. Participants were assigned to a multicomponent training programme (three days per week) and received either 3 g per day of citrulline malate or a placebo. Assessments were conducted before and after the intervention, including tests of physical performance (6MWT, sit-to-stand, SPPB), blood biomarkers (vitamin D, glucose, CK, hormones), and perceived quality of life (WHOQOL-BREF).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '60 Years', 'genderBased': True, 'genderDescription': 'Identified as women', 'healthyVolunteers': True, 'eligibilityCriteria': 'Each participant underwent a comprehensive medical evaluation by their primary care physician to confirm their health status and eligibility.\n\nInclusion criteria:\n\n* Sex: women.\n* Age: 60-75 years.\n\nExclusion criteria:\n\n* Functional limitations (Barthel Index \\<100 and/or Lawton-Brody Scale \\<8).\n* Musculoskeletal injuries within the past six months.\n* Cardiovascular disease (e.g. advanced heart failure, unstable angina, recent myocardial infarction, arrhythmias, uncontrolled hypertension or hypotension, aortic stenosis, thromboembolic events).\n* Respiratory disorders (e.g. chronic respiratory failure or a moderate/severe BODEx index).\n* Endocrine/metabolic diseases (e.g. uncontrolled diabetes).\n* Neurological or psychiatric disorders (e.g. dementia).\n* Prior use of ergogenic nutritional supplements.\n* Any other condition deemed incompatible with moderate physical activity by the clinical team.'}, 'identificationModule': {'nctId': 'NCT07143305', 'briefTitle': 'Effect of Citrulline Malate Supplementation on Physical Function and Biochemical Parameters in Physically Active Older Women', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Burgos'}, 'officialTitle': 'Effect of Citrulline Malate Supplementation During a Multicomponent Exercise Program on Physical Function and Biochemical Parameters in Physically Active Older Women: a Randomised Controlled Pilot Trial', 'orgStudyIdInfo': {'id': 'CITMAL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo supplementation with 3 g/day of maltodextrine', 'interventionNames': ['Other: Multicomponent physical exercise programme']}, {'type': 'EXPERIMENTAL', 'label': 'Supplementation', 'description': '3 g/day of citrulline malate', 'interventionNames': ['Other: Multicomponent physical exercise programme']}], 'interventions': [{'name': 'Multicomponent physical exercise programme', 'type': 'OTHER', 'description': 'Participants engaged in a multicomponent physical exercise programme designed specifically for older adults. The programme was based on the latest evidence and international recommendations for sarcopenia and functional maintenance in ageing population.', 'armGroupLabels': ['Placebo', 'Supplementation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Soria', 'country': 'Spain', 'facility': 'City Council of Soria', 'geoPoint': {'lat': 41.76401, 'lon': -2.46883}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Burgos', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Juan Francisco Mielgo', 'investigatorAffiliation': 'Universidad de Burgos'}}}}