Effects of Liposomal Encapsulation on Vitamin C Absorption and Metabolism

NCT ID: NCT06372171

Last Updated: 2024-04-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-30
• Study Completion Date: 2024-12-31

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 2,000 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 c.c., frequency: 1 time, total blood volume: 3 c.c.

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).

Conditions

Nutrition, Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Stage 1

Day 14

Group Type: OTHER

Satge 1

Intervention Type: DIETARY_SUPPLEMENT

General vitamin C powder group (Contains 1500 mg Vitamin C) Number 1-10 liposomal encapsulation C powder group (Contains 1500 mg of vitamin C and lecithin and is coated) Number 11-20

Stage 2

Day 28

Group Type: OTHER

Stage 2

Intervention Type: DIETARY_SUPPLEMENT

General vitamin C powder group (Contains 1500 mg Vitamin C) Number 11-20 liposomal encapsulation C powder group (Contains 1500 mg of vitamin C and lecithin and is coated) Number 1-10

Interventions

Satge 1

General vitamin C powder group (Contains 1500 mg Vitamin C) Number 1-10 liposomal encapsulation C powder group (Contains 1500 mg of vitamin C and lecithin and is coated) Number 11-20

Intervention Type: DIETARY_SUPPLEMENT

Stage 2

General vitamin C powder group (Contains 1500 mg Vitamin C) Number 11-20 liposomal encapsulation C powder group (Contains 1500 mg of vitamin C and lecithin and is coated) Number 1-10

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Adults aged 20-60 years old, without heart, liver, kidney, endocrine or major organic diseases (patient report), and able to fully cooperate with the experiment.

Exclusion Criteria

1. Patients with renal insufficiency and dialysis

2. Cancer patients

3. Underweight (BMI≦17) or obese (BMI≧27)

4. Those taking medications for chronic diseases

5. Blood pressure systolic blood pressure ≧ 130 mmHg or diastolic blood pressure ≧ 85 mmHg

6. Fasting blood glucose ≧ 100 mg/dL

7. Fasting triglycerides ≧ 150 mg/dL, total cholesterol ≧ 200 mg/dL

8. Have a history of vitamin C allergy

9. People suffering from mental illness

10. Pregnant and breastfeeding women

11. Patients with hemosiderosis

12. Kidney stone patients

13. People who take vitamin C for a long time should take supplements (at least 200 mg per day for more than one month)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Yang Ming Chiao Tung University

OTHER

Sponsor Role: lead

Responsible Party

YenPing, Lei

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

National Yang Ming Chiao Tung University

Taipei, Beitou Dist., Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

ChienYu Huang, Bachelor

Role: CONTACT

chienyu.ns11@nycu.edu.tw

+886-955-879163

Facility Contacts

Tze-Fang Wang, Ph.D.

Role: primary

tzefang@nycu.edu.tw

+886-2-28267907

Other Identifiers

NYCU112182AEF

Identifier Type: -

Identifier Source: org_study_id