Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-27 @ 12:35 PM
Study NCT ID:
NCT06110260
Status:
COMPLETED
Last Update Posted:
2025-12-18
First Post:
2023-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetic Effect of AstraGin on Whey Protein Absorption and Muscle Function in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000713447', 'term': 'Asian ginseng'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2024-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-10', 'studyFirstSubmitDate': '2023-10-26', 'studyFirstSubmitQcDate': '2023-10-26', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The AUC of BCAA in human plasma', 'timeFrame': '3 hr', 'description': 'Pharmacokinetic ( 0, 15, 30, 45, 60, 90, 120, 150, and 180 minutes)'}], 'secondaryOutcomes': [{'measure': 'Plasma TAC Test', 'timeFrame': '4weeks、12weeks'}, {'measure': 'Grip Strength', 'timeFrame': '4weeks、12weeks', 'description': 'Handgrip strength is assessed using a hand dynamometer to evaluate muscle strength'}, {'measure': 'Muscle Mass-DXA', 'timeFrame': '4weeks、12weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['BCAA', 'Ginseng and Astragalus Saponin Extract', 'Whey Protein', 'Pharmacokinetics'], 'conditions': ['Pharmacokinetic Effect of AstraGin on Whey Protein Absorption and Muscle Function in Healthy Subjects']}, 'descriptionModule': {'briefSummary': 'This study gave healthy people supplements with ginseng and astragalus saponin extracts (AstraGin), combined with whey protein, to explore whether it can promote amino acid absorption and thereby enhance protein nutritional status and muscle function.\n\nThis trial is a randomized, double-blind, crossover trial, and the research subjects are adult healthy subjects.', 'detailedDescription': 'A randomized-double blind, crossover human trial. 30 healthy adults, subdivided into two groups, are randomized into treatments and placebo groups to ensure equally balanced randomization and comparability, considering factors including age, sex, and diet.\n\n(2) The 1st round: Before each study day, all subjects took a 50 mg AstraGin/placebo (maltodextrin) capsule at 9 p.m. and began fasting for 12 hours, except for a small amount of water the night before the experiment. On each study day, all subjects collected their first blood sample at 9 a.m. from the median cubital vein using the indwelling catheter method. After the first blood collection, all subjects took 50 mg AstraGin/placebo and 35 g of whey protein with 250 mL water.\n\n(3) Additional blood samples were collected at 0, 15, 30, 45, 60, 90, 120, 150, and 180 min to analyze the plasma concentration of amino acids.\n\n(5) The washout period is seven days, during which the subjects maintain a stable lifestyle and dietary habits. The 2nd round: All subjects take a 50 mg Placebo/AstraGin capsule and conduct the procedure (same as the 1st round)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adults and aged 20-65 years.\n* Subject has provided written informed consent to participate in the study.\n* The subject is willing and able to comply with the study.\n\nExclusion Criteria:\n\n* The subject is participating in another clinical trial thirty days prior to enrollment.\n* Subject allergy to milk proteins\n* Subject has diabetes, obesity, hypertension, cardiovascular disease, liver or kidney disease, current infections, and smoking were exclusion criteria.\n* Subject has any medical condition or uses any medication, nutritional product, amino acids supplement, or program which might interfere with the conduct of the study or place the subject at risk.\n* Subjects lost to follow-up, non-compliance, and concomitant medication.'}, 'identificationModule': {'nctId': 'NCT06110260', 'briefTitle': 'Pharmacokinetic Effect of AstraGin on Whey Protein Absorption and Muscle Function in Healthy Subjects', 'organization': {'class': 'OTHER', 'fullName': 'Chung Shan Medical University'}, 'officialTitle': 'Pharmacokinetic Effect of AstraGin on Whey Protein Absorption and Muscle Function in Healthy Subjects: A Randomized, Double-blind, Crossover Trial.', 'orgStudyIdInfo': {'id': 'CS1-23151'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AstraGin', 'description': 'The 1st round: Before each study day, all subjects took a 50 mg AstraGin capsule at 9 p.m. and began fasting for 12 hours, except for a small amount of water the night before the experiment. On each study day, all subjects collected their first blood sample at 9 a.m. from the median cubital vein using the indwelling catheter method. After the first blood collection, all subjects took 50 mg AstraGin and 35 g of whey protein with 250 mL water.\n\nAdditional blood samples were collected at 0, 15, 30, 45, 60, 90, 120, 150, and 180 min to analyze the plasma concentration of amino acids.\n\nThe washout period is seven days, during which the subjects maintain a stable lifestyle and dietary habits.\n\nThe 2nd round: All subjects take a 50 mg AstraGin capsule and conduct the procedure (same as the 1st round)', 'interventionNames': ['Dietary Supplement: AstraGin (Ginseng and Astragalus Saponin Extract)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'The 1st round: Before each study day, all subjects took a 50 mg placebo (maltodextrin) capsule at 9 p.m. and began fasting for 12 hours, except for a small amount of water the night before the experiment. On each study day, all subjects collected their first blood sample at 9 a.m. from the median cubital vein using the indwelling catheter method. After the first blood collection, all subjects took 50 mg placebo and 35 g of whey protein with 250 mL water.\n\nAdditional blood samples were collected at 0, 15, 30, 45, 60, 90, 120, 150, and 180 min to analyze the plasma concentration of amino acids.\n\nThe washout period is seven days, during which the subjects maintain a stable lifestyle and dietary habits.\n\nThe 2nd round: All subjects take a 50 mg Placebo capsule and conduct the procedure (same as the 1st round)', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'AstraGin (Ginseng and Astragalus Saponin Extract)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'In this study, we are investigating the effects of AstraGin on healthy adults. The testing sample is orally administrated to subjects with 35g whey protein + AstraGin. After intervention, a 180-min kinetics study of plasma amino acids was conducted.', 'armGroupLabels': ['AstraGin']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'In this study, we are investigating the effects of AstraGin on healthy adults. The testing sample is orally administrated to subjects with 35g whey protein + Placebo. After intervention, a 180-min kinetics study of plasma amino acids was conducted.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taichung', 'country': 'Taiwan', 'facility': 'Chung Shan Medical University', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chung Shan Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}