Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06372171
Status:
RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-03-24
Brief Title:
Effects of Liposomal Encapsulation on Vitamin C Absorption and Metabolism
Sponsor:
National Yang Ming Chiao Tung University
Organization:
National Yang Ming Chiao Tung University
Study Overview
Official Title:
Effects of Liposomal Encapsulation on Vitamin C Absorption and Metabolism
Status:
RECRUITING
Status Verified Date:
2024-04
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:
Vitamin C is an important antioxidant in the human body and plays many important roles It is currently known that vitamin C has the functions of treating scurvy assisting in collagen synthesis whitening and increasing immunity Smokers patients with cardiovascular disease and patients with diabetes may have higher requirements for vitamins due to higher oxidative stress in the body Liposome coating is a technology commonly used in food processing and medicine to protect active substances increase absorption or slow release Currently vitamin C is commonly available on the market as an additive nutritional supplement in the form of powder packets tablets etc The disadvantages are that vitamin C is relatively unstable easily destroyed by gastric acid and maintains blood concentration for a short time Taking liposome microbial C has been Found to have the potential to increase bioavailability in the human body it is expected that vitamin C coated with lecithin is relatively stable and can be stabilized in the small intestine without being damaged by gastric acid while reducing the risk of gastrointestinal discomfort caused by the acidity of vitamin C According to the revised seventh edition of the Reference Intake of Dietary Nutrients for Chinese People the upper daily intake of vitamin C tolerable upper intake levels UL for people aged 19 to 70 is 2000 mg According to literature the absorption rate of vitamin C when consuming 30-180 mg per day is about 70-90 when the daily intake exceeds 1000 mg the absorption rate will drop to less than 50 The dose of vitamin C used in this study is more than 1500 mg The purpose is to explore whether the sustained-release characteristics of liposome coating technology can improve the absorption rate and achieve better bioavailability when consuming high-dose vitamin C powder It is expected that through the egg The liposome vitamin C powder made of phospholipids increases its maintenance time in the blood thereby increasing the supplementary effect of vitamin C powder and serving as another supplement option for vitamin C
Detailed Description:
The trial is divided into two parts the first part is pre-trial screening and the second part is clinical trial
This trial will first conduct the following tests to confirm that the subjects meet the inclusion and exclusion conditions before screening before they are eligible for the formal trial
1 General examination height weight blood pressure
2 Blood biochemical index detection fasting blood glucose triglycerides total cholesterol Blood urea nitrogen Creatinine GOT GPT single blood draw volume 3 cc frequency 1 time total blood volume 3 cc
It is expected to recruit 20 eligible healthy subjects This trial adopts a two-stage open crossover trial Crossover design After the subjects join the trial they need to participate in a total of 2 trials After each trial is completed a 14-day interval washout period is required before the next trial the first trial can be conducted 14 days apart second test At the beginning of the experiment the subjects drew lots to determine their numbers and the order of participating groups the participating groups in the two experiments will not be repeated
This trial will first conduct the following tests to confirm that the subjects meet the inclusion and exclusion conditions before screening before they are eligible for the formal trial
1 General examination height weight blood pressure
2 Blood biochemical index detection fasting blood glucose triglycerides total cholesterol Blood urea nitrogen Creatinine GOT GPT single blood draw volume 3 cc frequency 1 time total blood volume 3 cc
It is expected to recruit 20 eligible healthy subjects This trial adopts a two-stage open crossover trial Crossover design After the subjects join the trial they need to participate in a total of 2 trials After each trial is completed a 14-day interval washout period is required before the next trial the first trial can be conducted 14 days apart second test At the beginning of the experiment the subjects drew lots to determine their numbers and the order of participating groups the participating groups in the two experiments will not be repeated
Study Oversight
Has Oversight DMC:
None
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?:
None