Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2025-12-25 @ 11:40 PM
Study NCT ID:
NCT05586295
Status:
COMPLETED
Last Update Posted:
2022-10-19
First Post:
2022-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vitamin B Complex Improved Exercise Performance and Anti-fatigue
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, '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': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2021-06-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-17', 'studyFirstSubmitDate': '2022-09-12', 'studyFirstSubmitQcDate': '2022-10-17', 'lastUpdatePostDateStruct': {'date': '2022-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Exercise endurance exhaustion time', 'timeFrame': '28 days', 'description': 'Investigators adopted a double-blind test in which the volunteers, based on their basal maximal oxygen consumption (VO2max). before and after intervention, the individual basal VO2max during pretest was used as a reference to adjust the individually appropriate exercise intensity to measure exhaustive endurance (85% VO2max) and recording the running time from begin to exhaust.'}, {'measure': 'Clinical Biochemistry of lactate level', 'timeFrame': '28 days', 'description': 'For assessment of fatigue-related indices, volunteers fasted for at least 8 h before the 60% VO2max fixed intensity exercise challenge. Blood samples were collected with an arm venous catheter at indicated time points during exercise and recovery periods, including baseline (0), 5 (E5), 10 (E10), 15 (E15), and 30 (E30) min during the exercise phase, and 20 (R20), 40 (R40), 60 (R60), and 90 (R90) min in the recovery phase. Serum lactate (mmol/L), were assessed for monitoring physiological adaptation. All biochemical indices were assessed using an autoanalyzer (Hitachi 7060, Tokyo, Japan).'}, {'measure': 'Clinical Biochemistry of ammonia level', 'timeFrame': '28 days', 'description': 'For assessment of fatigue-related indices, volunteers fasted for at least 8 h before the 60% VO2max fixed intensity exercise challenge. Blood samples were collected with an arm venous catheter at indicated time points during exercise and recovery periods, including baseline (0), 5 (E5), 10 (E10), 15 (E15), and 30 (E30) min during the exercise phase, and 20 (R20), 40 (R40), 60 (R60), and 90 (R90) min in the recovery phase. Serum ammonia (umol/L), were assessed for monitoring physiological adaptation. All biochemical indices were assessed using an autoanalyzer (Hitachi 7060, Tokyo, Japan).'}, {'measure': 'Clinical Biochemistry of CK level', 'timeFrame': '28 days', 'description': 'For assessment of fatigue-related indices, volunteers fasted for at least 8 h before the 60% VO2max fixed intensity exercise challenge. Blood samples were collected with an arm venous catheter at indicated time points during exercise and recovery periods, including baseline (0), 5 (E5), 10 (E10), 15 (E15), and 30 (E30) min during the exercise phase, and 20 (R20), 40 (R40), 60 (R60), and 90 (R90) min in the recovery phase. Serum CK (U/L), were assessed for monitoring physiological adaptation. All biochemical indices were assessed using an autoanalyzer (Hitachi 7060, Tokyo, Japan).'}, {'measure': 'Clinical Biochemistry of glucose level', 'timeFrame': '28 days', 'description': 'For assessment of fatigue-related indices, volunteers fasted for at least 8 h before the 60% VO2max fixed intensity exercise challenge. Blood samples were collected with an arm venous catheter at indicated time points during exercise and recovery periods, including baseline (0), 5 (E5), 10 (E10), 15 (E15), and 30 (E30) min during the exercise phase, and 20 (R20), 40 (R40), 60 (R60), and 90 (R90) min in the recovery phase. Serum glucose (mg/dL), were assessed for monitoring physiological adaptation. All biochemical indices were assessed using an autoanalyzer (Hitachi 7060, Tokyo, Japan).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Exercise Performance', 'Fatigue']}, 'descriptionModule': {'briefSummary': "The aim of the present study was to evaluate potential beneficial effects of TTFD® EX PLUS (Prince Pharmaceutical Co., Ltd., Yunlin County, Taiwan) on fatigue and ergogenic functions following physiological challenge. The test used a double-blind crossover design and supplementation for 28 days. 32 male and female 20-30 year-old subjects were divided into two groups in a balanced order according to each individual's initial maximal oxygen uptake and were assigned to receive a placebo with equal gender (non TTFD® EX PLUS with same color/day, n=16, 8 male and 8 female) or TTFD® EX PLUS (600mg/tablet/day, n=16, 8 male and 8 female) every morning. After the intervention, there were 28 days of wash-out, during which time the subjects did not receive further interventions."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>20 years old\n* \\>health\n\nExclusion Criteria:\n\n* No smoking\n* drinking habits\n* no nutritional supplements or medications\n* no food allergies\n* normal liver and kidney function\n* no diabetes and other chronic diseases'}, 'identificationModule': {'nctId': 'NCT05586295', 'briefTitle': 'Vitamin B Complex Improved Exercise Performance and Anti-fatigue', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan Sport University'}, 'officialTitle': 'The Functional Evaluation on Antifatigue and Improving Sports Performance by Vitamin B Complex of BULIKELAO Sugar-coated Tablet', 'orgStudyIdInfo': {'id': '20-037-A2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'EX plus', 'interventionNames': ['Other: EX plus']}], 'interventions': [{'name': 'Placebo', 'type': 'OTHER', 'description': 'Microcrystalline α-cellulose, shellac, calcium hydrogen phosphate, edible yellow No. 4, edible yellow No. 5, sucrose, silica, talc, oxidized starch, gelatin, magnesium stearate, palm wax.', 'armGroupLabels': ['Placebo']}, {'name': 'EX plus', 'type': 'OTHER', 'description': 'Furanthiamine hydrochloride (vitamin B1), pyridoxine hydrochloride (vitamin B6), cyanocobalamin (vitamin B12), DL-alpha-tocopheryl acetate 50% (DL-alpha-tocopheryl acetate, sucrose, caprylic acid) Sodium alkenyl succinate starch, corn starch, water, sodium aluminosilicate), shellac, calcium hydrogen phosphate, edible yellow No. 4, edible yellow No. 5, γ-oryzanol (γ-oryzanol, rice bran powder ), sucrose, silica, inositol, taurine, talc, oxidized starch, gelatin, magnesium stearate, calcium panpolyate, microcrystalline α-cellulose, riboflavin (vitamin B2), palmar wax.', 'armGroupLabels': ['EX plus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33301', 'city': 'Taoyuan District', 'country': 'Taiwan', 'facility': 'Graduate Institute of Sports Science, National Taiwan Sport University', 'geoPoint': {'lat': 24.9896, 'lon': 121.3187}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan Sport University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Prince Pharmaceutical Co., Ltd', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Distinguished Professor', 'investigatorFullName': 'Chi-Chang Huang', 'investigatorAffiliation': 'National Taiwan Sport University'}}}}