Ignite Creation Date:
2025-12-24 @ 9:17 PM
Ignite Modification Date:
2026-01-05 @ 8:06 AM
Study NCT ID:
NCT03810404
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2019-01-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Sodium Bicarbonate Supplementation in Athletes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-01-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-14', 'studyFirstSubmitDate': '2019-01-14', 'studyFirstSubmitQcDate': '2019-01-17', 'lastUpdatePostDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in anaerobic capacity after sodium bicarbonate supplementation and placebo treatment', 'timeFrame': 'Baseline and during 1 day of acute SB and PLA supplementation', 'description': 'The Wingate cycling test carried out at baseline, and after SB and PLA supplementation'}, {'measure': 'Changes in discipline-specific exercise capacity after sodium bicarbonate supplementation and placebo treatment', 'timeFrame': 'Baseline and during 1 day of acute SB and PLA supplementation', 'description': 'The discipline-specific exercise capacity tests carried out at baseline, and after SB and PLA supplementation'}, {'measure': 'Changes of bicarbonate concentration in blood after sodium bicarbonate supplementation and placebo treatment', 'timeFrame': 'Baseline and during 1 day of acute SB and PLA supplementation', 'description': 'Bicarbonate (HCO3-) \\[mmol/L\\] concentration analysis in blood carried out at baseline, and after SB and PLA supplementation'}, {'measure': 'Changes of base excess concentration in blood after sodium bicarbonate supplementation and placebo treatment', 'timeFrame': 'Baseline and during 1 day of acute SB and PLA supplementation', 'description': 'Base excess \\[mmol/L\\] concentration analysis in blood carried out at baseline, and after SB and PLA supplementation'}], 'secondaryOutcomes': [{'measure': 'Changes of pH in blood after sodium bicarbonate supplementation and placebo treatment', 'timeFrame': 'Baseline and during 1 day of acute SB and PLA supplementation', 'description': 'Blood pH (pH units) analysis carried out at baseline, and after SB and PLA supplementation'}, {'measure': 'Changes of lactate concentration in blood after sodium bicarbonate supplementation and placebo treatment', 'timeFrame': 'Baseline and during 1 day of acute SB and PLA supplementation', 'description': 'Lactate \\[mmol/L\\] concentration analysis carried out at baseline, and after SB and PLA supplementation'}, {'measure': 'Changes of pyruvate concentration in blood after sodium bicarbonate supplementation and placebo treatment', 'timeFrame': 'Baseline and during 1 day of acute SB and PLA supplementation', 'description': 'Pyruvate \\[mmol/L\\] concentration analysis carried out at baseline, and after SB and PLA supplementation'}, {'measure': 'Changes in blood glucose concentration after sodium bicarbonate supplementation and placebo treatment', 'timeFrame': 'Baseline and during 1 day of acute SB and PLA supplementation', 'description': 'Glucose \\[g/dl\\] concentration analysis carried out at baseline, and after SB and PLA supplementation'}, {'measure': 'Changes in hemoglobin concentration after sodium bicarbonate supplementation and placebo treatment', 'timeFrame': 'Baseline and during 1 day of acute SB and PLA supplementation', 'description': 'Hemoglobin (Hb) \\[g/dl\\] concentration analysis carried out at baseline, and after SB and PLA supplementation'}, {'measure': 'Changes of blood cells concentration in blood after sodium bicarbonate supplementation and placebo treatment', 'timeFrame': 'Baseline and during 1 day of acute SB and PLA supplementation', 'description': 'Blood cells \\[mln/mm³\\] concentration analysis carried out at baseline, and after SB and PLA supplementation'}, {'measure': 'Changes of creatine kinase activity in blood after sodium bicarbonate supplementation and placebo treatment', 'timeFrame': 'Baseline and during 1 day of acute SB and PLA supplementation', 'description': 'Creatine kinase \\[U/L\\] activity analysis carried out at baseline, and after SB and PLA supplementation'}, {'measure': 'Changes of lactate dehydrogenase activity in blood after sodium bicarbonate supplementation and placebo treatment', 'timeFrame': 'Baseline and during 1 day of acute SB and PLA supplementation', 'description': 'Lactate dehydrogenase \\[U/L\\] activity analysis carried out at baseline, and after SB and PLA supplementation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sports nutrition', 'Sodium bicarbonate', 'Physical capacity', 'Exercise performance', 'Buffering potential', 'Biochemical markers'], 'conditions': ['Supplementation', 'Sport']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to verify the effect of acute sodium bicarbonate (SB) and placebo (PLA) supplementation on buffering potential kinetics, physical capacity, discipline-specific performance as well as concentration of diagnostically significant blood biochemical indices in athletes, in a randomised, double-blind, placebo-controlled crossover trial.', 'detailedDescription': 'Effective muscle work is conditioned by maintaining the proper range of muscles pH, regulated by buffering systems, in which the main role is played by bicarbonates (HCO3-). For this reason, sodium bicarbonate (SB) is often proposed as an ergogenic agent, especially during high-intensity efforts. Until now the major limitation to SB supplementation has been the gastrointestinal (GI) side effects. There is also a lack of data of the individual SB-induced changes of buffering potential kinetics and its actual connection with physical capacity and discipline-specific performance. Therefore, this study aims to examine the effect of acute, different-dose SB ingestion on buffering potential kinetics, physical capacity, discipline-specific performance as well as changes of diagnostically significant blood biochemical indices concentration in athletes, in a randomised, double-blind, placebo-controlled crossover trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* written consent to participate,\n* a current medical clearance to practice sports,\n* training experience: at least 2 years,\n* minimum of 4 workout sessions (in the discipline covered by the study) a week.\n\nExclusion Criteria:\n\n* current injury,\n* any health-related contraindication,\n* declared general feeling of being unwell,\n* unwilling to follow the study protocol.'}, 'identificationModule': {'nctId': 'NCT03810404', 'briefTitle': 'Acute Sodium Bicarbonate Supplementation in Athletes', 'organization': {'class': 'OTHER', 'fullName': 'Poznan University of Physical Education'}, 'officialTitle': 'The Effect of Acute Sodium Bicarbonate Supplementation on Buffering Potential Kinetics, Physical Capacity and Discipline-Specific Performance', 'orgStudyIdInfo': {'id': 'ULS00006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sodium bicarbonate supplementation', 'description': 'Group taking oral SB supplementation in a different-dose regimen.', 'interventionNames': ['Dietary Supplement: Sodium bicarbonate supplementation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo treatment', 'description': 'Group taking oral supplementation with placebo (NaCl).', 'interventionNames': ['Dietary Supplement: Placebo treatment']}], 'interventions': [{'name': 'Sodium bicarbonate supplementation', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Interventions:\n\nThe experimental procedure for each athlete included an acute SB supplementation in a different-dose regimen in order to assess whether the dose affects the actual physical and exercise capacity (doses: 0.15-, 0.25-, 0.35- and 0.50 g/kgFFM (0.12-, 0.20-, 0.28- and 0.40 g/kgBM), respectively). SB (Alkala, SANUM, Poland) will be administered as dissolved form in a 750 ml of fluid (water + fruit juice). On testing days the SB will be taken before physical and exercise capacity tests session.\n\nBetween the SB and PLA or a PLA and SB treatments, a minimum 7-day washout period will be introduced.', 'armGroupLabels': ['Sodium bicarbonate supplementation']}, {'name': 'Placebo treatment', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Interventions:\n\nThe experimental procedure for each athlete will be included an PLA supplementation. Placebo will be administered in a form of 750 ml of fluid (water + fruit juice). On testing days the PLA will be taken before physical and exercise capacity tests session.\n\nBetween the PLA and SB or a SB and PLA treatments, a minimum 7-day washout period will be introduced.', 'armGroupLabels': ['Placebo treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61-871', 'city': 'Poznan', 'country': 'Poland', 'facility': 'Department of Sports Dietetics, Poznan University of Physical Education', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}], 'overallOfficials': [{'name': 'Krzysztof Durkalec-Michalski, Prof., PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Sports Dietetics, Poznan University of Physical Education'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Shared data will be exclusively related to the level of recorded indicators, without personal data. The data obtained will be attached to scientific publications, depending on the requirements of the journal.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poznan University of Physical Education', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Krzysztof Durkalec-Michalski', 'investigatorAffiliation': 'Poznan University of Physical Education'}}}}