- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07302828
Effect of Double Nutri® Liposomal Encapsulation Technology on Human Absorption of Vitamin C and Glutathione Liquid Sachet
Study Overview
Status
Conditions
Detailed Description
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.
Healthy 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.
After 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Taipei, Taiwan, 114
- TCI Co., Ltd
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Pregnant or breastfeeding women, or individuals unwilling to use physical contraceptive methods during the study period, such as condoms or intrauterine devices (IUDs).
- Employees of TCI Co., Ltd and their family members.
- 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.
- 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.
- Individuals who have undergone gastrointestinal surgery, organ transplantation, or other major surgical procedures.
- Individuals who experienced acute gastroenteritis within two weeks prior to study initiation.
- Individuals with a known allergy to any components of the testing samples.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Vitamin C and Glutathione without liposome
Each administration consists of two sachets, with each sachet containing 1,000 mg of vitamin C and 60 mg of glutathione
|
Each administration consists of two sachets, with each sachet containing 1,000 mg of vitamin C and 60 mg of glutathione.
|
|
Experimental: Liposomal Vitamin C and Glutathione
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
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood vitamin C level (ug/mL)
Time Frame: at 8 hours after taking test sample
|
Blood vitamin C levels will be measured at fasting and at 0.5, 1, 2, 4, 6, and 8 hours post-intake.
|
at 8 hours after taking test sample
|
|
Blood glutathione level (μmol/L)
Time Frame: at 8 hours after taking test sample
|
Whole blood glutathione levels will be measured at fasting and at 0.5, 1, 2, 4, 6, and 8 hours post-intake.
|
at 8 hours after taking test sample
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tong-Lin Wu, TCI Co., Ltd.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Peptides
- Amino Acids, Peptides, and Proteins
- Oligopeptides
- Organic Chemicals
- Pharmaceutical Preparations
- Dosage Forms
- Carbohydrates
- Sugar Acids
- Acids, Acyclic
- Carboxylic Acids
- Hydroxy Acids
- Biomedical and Dental Materials
- Manufactured Materials
- Technology, Industry, and Agriculture
- Membranes, Artificial
- Drug Carriers
- Biomimetic Materials
- Ascorbic Acid
- Liposomes
- Glutathione
Other Study ID Numbers
- 25-098-A
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Glutathione
-
Qualia Life SciencesNot yet recruitingGlutathione | Effects of Qualia Glutathione+ on Blood Glutathione LevelsUnited States
-
Dr Irma Bernadette S SitohangCompleted
-
Aristotle University Of ThessalonikiNational and Kapodistrian University of Athens; European University CyprusCompletedGlutathione Metabolism AnemiasCyprus, Greece
-
University Hospital, Strasbourg, FranceUnknownThe Glutathione Synthetase DeficiencyFrance
-
University Hospital, Clermont-FerrandUMR 1019 Unité de Nutrition Humaine; Laboratoire Régional de Nutrition HumaineCompletedAssay Muscle | Liver Glutathione in Healthy HumanFrance
-
Cairo UniversityFayoum UniversityRecruitingGlutathione | Gingival Pigmentation | Vitamin C | DepigmentationEgypt
-
Western University of Health SciencesCompletedGlutathione-cyclodextrin Complex AbsorptionUnited States
-
Baylor College of MedicineCompletedMuscle Weakness | Aging | Erythrocyte Glutathione DeficiencyUnited States
-
All India Institute of Medical Sciences, BhubaneswarNot yet recruitingThe Goal of This Trial is to to Compare the Effect of Risperidone vs Aripiprazole in Terms of Change in Serum Glutathione Level
-
University of FloridaWithdrawnAortic Stenosis | Transcatheter Aortic Valve Replacement | Glutathione Peroxidase ActivityUnited States
Clinical Trials on Vitamin C and Glutathione without liposome
-
University of Maryland, BaltimoreCompleted
-
TCI Co., Ltd.CompletedVitamin C DeficiencyTaiwan
-
Cairo UniversityFayoum UniversityRecruitingGlutathione | Gingival Pigmentation | Vitamin C | DepigmentationEgypt
-
TCI Co., Ltd.RecruitingSkin Condition | Anti-Oxidative StressTaiwan
-
University of LouisvilleNorton Healthcare; Cumberland PharmaceuticalsCompletedAutism | Severe Behavior DisorderUnited States
-
National Institute of Diabetes and Digestive and...Completed
-
Democritus University of ThraceCompleted
-
Taichung Veterans General HospitalUnknownLiver Cirrhosis | Liver CancerTaiwan
-
Shiraz University of Medical SciencesCompletedRestless Legs Syndrome | Kidney Failure, ChronicIran, Islamic Republic of
-
PepsiCo Global R&DFood and Nutrition Research Institute, PhilippinesCompleted