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:
TCI Co., Ltd.
Organization:
Study Overview
Official Title:
Effect of Double Nutri® Liposomal Encapsulation Technology on Human Absorption of Vitamin C and Glutathione Liquid Sachet
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: