Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2025-12-29 @ 7:34 PM
Study NCT ID:
NCT07302828
Status:
RECRUITING
Last Update Posted:
2025-12-24
First Post:
2025-12-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Double Nutri® Liposomal Encapsulation Technology on Human Absorption of Vitamin C and Glutathione Liquid Sachet
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001205', 'term': 'Ascorbic Acid'}, {'id': 'D005978', 'term': 'Glutathione'}, {'id': 'D008081', 'term': 'Liposomes'}], 'ancestors': [{'id': 'D013400', 'term': 'Sugar Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D008567', 'term': 'Membranes, Artificial'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D004337', 'term': 'Drug Carriers'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}, {'id': 'D040761', 'term': 'Biomimetic Materials'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2025-12-11', 'studyFirstSubmitQcDate': '2025-12-11', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood vitamin C level (ug/mL)', 'timeFrame': 'at 8 hours after taking test sample', 'description': 'Blood vitamin C levels will be measured at fasting and at 0.5, 1, 2, 4, 6, and 8 hours post-intake.'}, {'measure': 'Blood glutathione level (μmol/L)', 'timeFrame': 'at 8 hours after taking test sample', 'description': 'Whole blood glutathione levels will be measured at fasting and at 0.5, 1, 2, 4, 6, and 8 hours post-intake.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vitamin c', 'glutathione', 'liposomal', 'human bioavailability', 'Double Nutri'], 'conditions': ['Vitamin C', 'Glutathione']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate whether Double Nutri® liposomal encapsulation technology can enhance the oral absorption of liquid vitamin C and glutathione supplements in humans.', 'detailedDescription': 'This study is a single-center, self-controlled crossover human trial designed to evaluate the differences in blood concentration changes and bioavailability following a single oral dose of liquid vitamin C and glutathione supplements.\n\nHealthy adult participants aged 18 years and older will be enrolled. Each participant will complete two study sessions, with a minimum washout period of 7 days between sessions. On each study day, venous blood samples will be collected prior to test product administration (0 minutes) to assess vitamin C levels, glutathione levels, complete blood count, blood lipids, blood glucose, and liver and kidney function indicators.\n\nAfter baseline blood collection, a standardized breakfast will be provided and consumed within 10 minutes, followed by administration of the test product. Venous blood samples will then be collected at 0.5, 1, 2, 4, 6, and 8 hours post-intake to measure vitamin C and glutathione concentrations. Lunch will be provided after the 4-hour blood draw, and dinner will be provided after the 8-hour blood draw. Identical meals will be provided during both study sessions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults aged 18 years or older, of any sex, who are willing to sign the informed consent form and are able to fully comply with all study procedures.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women, or individuals unwilling to use physical contraceptive methods during the study period, such as condoms or intrauterine devices (IUDs).\n* Employees of TCI Co., Ltd and their family members.\n* Individuals who, within 30 days prior to study initiation, have been taking vitamin C supplements at doses greater than 200 mg per day, glutathione supplements at doses greater than 100 mg per day, or medications that may affect endogenous vitamin C or glutathione levels, such as oral contraceptives and estrogen preparations (including ethinylestradiol, desogestrel, gestodene, drospirenone, cyproterone acetate), or acetaminophen.\n* Individuals with chronic gastrointestinal diseases (including irritable bowel syndrome \\[IBS\\], inflammatory bowel disease \\[IBD\\], chronic diarrhea, Crohn's disease, celiac disease, bowel control disorders/fecal incontinence, pancreatitis, peptic ulcer disease, colorectal cancer, short bowel syndrome, and ulcerative colitis), a history of epilepsy or seizures, liver or kidney disease, malignancy, endocrine disorders, psychiatric disorders, alcohol or drug abuse, or other significant organic diseases based on medical history.\n* Individuals who have undergone gastrointestinal surgery, organ transplantation, or other major surgical procedures.\n* Individuals who experienced acute gastroenteritis within two weeks prior to study initiation.\n* Individuals with a known allergy to any components of the testing samples."}, 'identificationModule': {'nctId': 'NCT07302828', 'briefTitle': 'Effect of Double Nutri® Liposomal Encapsulation Technology on Human Absorption of Vitamin C and Glutathione Liquid Sachet', 'organization': {'class': 'INDUSTRY', 'fullName': 'TCI Co., Ltd.'}, 'officialTitle': 'Effect of Double Nutri® Liposomal Encapsulation Technology on Human Absorption of Vitamin C and Glutathione Liquid Sachet', 'orgStudyIdInfo': {'id': '25-098-A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Vitamin C and Glutathione without liposome', 'description': 'Each administration consists of two sachets, with each sachet containing 1,000 mg of vitamin C and 60 mg of glutathione', 'interventionNames': ['Dietary Supplement: Vitamin C and Glutathione without liposome']}, {'type': 'EXPERIMENTAL', 'label': 'Liposomal Vitamin C and Glutathione', 'description': 'Each administration consists of two sachets, with each sachet containing 1,000 mg of vitamin C and 60 mg of glutathione, and the test sample is processed using the Double Nutri liposomal technology', 'interventionNames': ['Dietary Supplement: Liposomal Vitamin C and Glutathione']}], 'interventions': [{'name': 'Vitamin C and Glutathione without liposome', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Each administration consists of two sachets, with each sachet containing 1,000 mg of vitamin C and 60 mg of glutathione.', 'armGroupLabels': ['Vitamin C and Glutathione without liposome']}, {'name': 'Liposomal Vitamin C and Glutathione', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['GLUTA BRIGHT', 'Double Nutri Vitamin C and Glutathione'], 'description': 'Each administration consists of two sachets, with each sachet containing 1,000 mg of vitamin C and 60 mg of glutathione, and the product is processed using the Double Nutri liposomal technology.', 'armGroupLabels': ['Liposomal Vitamin C and Glutathione']}]}, 'contactsLocationsModule': {'locations': [{'zip': '114', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Ping Lin', 'role': 'CONTACT', 'email': 'candice.lin@tci-bio.com', 'phone': '+886 02-8797-7811'}], 'facility': 'TCI Co., Ltd', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Tong-Lin Wu', 'role': 'CONTACT', 'email': 'Tony.Wu@tci-bio.com', 'phone': '+886 02-87977811'}, {'name': 'Ping Lin', 'role': 'CONTACT', 'email': 'candice.lin@tci-bio.com', 'phone': '+886 02-87977811'}], 'overallOfficials': [{'name': 'Tong-Lin Wu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'TCI Co., Ltd.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TCI Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}