Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-02-17 @ 5:25 PM
Study NCT ID:
NCT03165357
Status:
COMPLETED
Last Update Posted:
2017-05-24
First Post:
2017-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2016-04-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-23', 'studyFirstSubmitDate': '2017-05-22', 'studyFirstSubmitQcDate': '2017-05-23', 'lastUpdatePostDateStruct': {'date': '2017-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in aerobic capacity after sodium bicarbonate supplementation', 'timeFrame': 'Baseline and after 10 days', 'description': 'The incremental cycling test (ICT)'}, {'measure': 'Changes in specific performance capacity after sodium bicarbonate supplementation', 'timeFrame': 'Baseline and after 10 days', 'description': 'The CrossFit-specific physical fitness test: Fight Gone Bad (FGB)'}], 'secondaryOutcomes': [{'measure': 'Changes in fat mass and fat free mass after sodium bicarbonate supplementation', 'timeFrame': 'Baseline and after 10 days', 'description': 'Fat mass (kg) and fat free mass (kg) analysis'}, {'measure': 'Changes of red and white blood cell concentration in blood after sodium bicarbonate supplementation', 'timeFrame': 'Baseline and after 10 days', 'description': 'Red blood cells (RBC) \\[mln/mm³\\] and white blood cells (WBC) \\[mln/mm³\\] concentration analysis'}, {'measure': 'Changes in blood glucose and hemoglobin concentration after sodium bicarbonate supplementation', 'timeFrame': 'Baseline and after 10 days', 'description': 'Hemoglobin (Hb) \\[g/dl\\] and glucose \\[g/dl\\] concentration analysis'}, {'measure': 'Changes in blood hematocrit levels after sodium bicarbonate supplementation', 'timeFrame': 'Baseline and after 10 days', 'description': 'Hematocrit (HCT) \\[%\\] level analysis'}, {'measure': 'Changes of lactate and pyruvate concentration in blood after sodium bicarbonate supplementation', 'timeFrame': 'Baseline and after 10 days', 'description': 'Lactate \\[mmol/L\\] and pyruvate \\[mmol/L\\] concentration analysis'}, {'measure': 'Changes of creatine kinase and lactate dehydrogenase activity in blood after sodium bicarbonate supplementation', 'timeFrame': 'Baseline and after 10 days', 'description': 'Creatine kinase \\[U/L\\] and lactate dehydrogenase \\[U/L\\] activity analysis'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Crossfit', 'Sodium bicarbonate', 'Physical capacity'], 'conditions': ['Supplementation', 'Sport']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to verify the effect of 10-day sodium bicarbonate (NaHCO3) and placebo (PLA) supplementation on body composition, physical capacity, as well as concentrations of the selected biochemical blood markers in trained athletes, in a randomised, double-blind, placebo-controlled crossover trial.', 'detailedDescription': 'Sodium bicarbonate (NaHCO3) was proposed as an ergogenic agent, because it improves high-intensity and resistance exercise performance. Until now the major limitation to NaHCO3 supplementation has been the gastrointestinal (GI) side effects. Therefore, this study aims to examine the effect of chronic, progressive- dose NaHCO3 ingestion on physical capacity, body composition and concentrations of the selected biochemical blood markers in trained athletes, in a randomised, double-blind, placebo-controlled crossover trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '43 Years', 'minimumAge': '20 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 (of CrossFit training),\n* minimum of 3 workout sessions (CrossFit) a week,\n* 20-43 years.\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': 'NCT03165357', 'briefTitle': 'Sodium Bicarbonate Supplementation in Athletes', 'organization': {'class': 'OTHER', 'fullName': 'Poznan University of Life Sciences'}, 'officialTitle': 'The Effect of Sodium Bicarbonate Supplementation on Physical Capacity and Body Composition in Trained Athletes', 'orgStudyIdInfo': {'id': 'ULS00002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sodium bicarbonate', 'description': 'Group taking oral NaHCO3 supplementation in a progressive-dose regimen.\n\nInterventions:\n\nThe experimental procedure for each athlete included a 10-day NaHCO3 supplementation in a progressive-dose regimen in order to reduce the likelihood of gastrointestinal side effects (from 37.5 to 150 mg ∙ kg-1). NaHCO3 was administered in the form of unmarked disk-shaped tablets (Alkala T, SANUM, Poland). The tablets were ingested with at least 250 mL of water and could be either swallowed or dissolved in the mouth. On training days the supplements were taken in the morning, in the evening and 1.5 hours before training session. On rest days the supplements were taken in the morning, in the afternoon and in the evening.\n\nBetween the 10-day NaHCO3 and PLA or a PLA and NaHCO3 treatments, a 14-day washout period was introduced.', 'interventionNames': ['Dietary Supplement: Sodium bicarbonate supplementation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (maltodextrin)', 'description': 'Group taking oral supplementation with placebo (maltodextrin).\n\nInterventions:\n\nThe experimental procedure for each athlete included a 10-day placebo administration. Placebo was ingested with at least 250 mL of water. On training days the supplements were taken in the morning, in the evening and 1.5 hours before training session. On rest days the supplements were taken in the morning, in the afternoon and in the evening.\n\nBetween the 10-day NaHCO3 and PLA or a PLA and NaHCO3 treatments, a 14-day washout period was introduced.', 'interventionNames': ['Dietary Supplement: Placebo treatment']}], 'interventions': [{'name': 'Sodium bicarbonate supplementation', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Sodium bicarbonate']}, {'name': 'Placebo treatment', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Placebo (maltodextrin)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60-624', 'city': 'Poznan', 'state': 'Wielkopolska', 'country': 'Poland', 'facility': 'Poznan University of Life Sciences, ul.Wojska Polskiego 31', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}], 'overallOfficials': [{'name': 'Jan Jeszka, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Hygiene and Human Nutrition, Poznan University of Life Sciences, Poznan, Poland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Shared data will be exclusively related to the level recorded indicators (body composition, aerobic and anaerobic capacity indicators, levels of biochemical markers), 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 Life Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'Poznan University of PhysED', 'class': 'INDIV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}