Effects of Liposomal Encapsulation on Vitamin C Absorption and Metabolism

NCT06372171 | Recruiting

• 1 other identifier: NYCU112182AEF
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Nutrition, Healthy

Outcome Measures

Primary Outcomes (2)

• General examination

  BMI(Body Mass Index is a simple calculation using a person's height and weight. The formula is BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in metres squared) and blood pressure

  Day 14 and 28

• Hematology Test

  Fasting blood glucose, triglycerides, total cholesterol, Blood urea nitrogen, Creatinine(Blood urea nitrogen (BUN) and creatinine tests can be used together to find the BUN-to-creatinine ratio (BUN:creatinine). A BUN-to-creatinine ratio can help your doctor check for problems, such as dehydration, that may cause abnormal BUN and creatinine levels.), GOT, GPT

  Day 14 and 28

Study Arms (2)

Stage 1

OTHER

Day 14

Dietary Supplement: Satge 1

Stage 2

OTHER

Day 28

Dietary Supplement: Stage 2

Interventions

Satge 1 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 1

Stage 2 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

Stage 2

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Patients with renal insufficiency and dialysis
• Cancer patients
• Underweight (BMI≦17) or obese (BMI≧27)
• Those taking medications for chronic diseases
• Blood pressure systolic blood pressure ≧ 130 mmHg or diastolic blood pressure ≧ 85 mmHg
• Fasting blood glucose ≧ 100 mg/dL
• Fasting triglycerides ≧ 150 mg/dL, total cholesterol ≧ 200 mg/dL
• Have a history of vitamin C allergy
• People suffering from mental illness
• Pregnant and breastfeeding women
• Patients with hemosiderosis
• Kidney stone patients
• People who take vitamin C for a long time should take supplements (at least 200 mg per day for more than one month)

Sponsors & Collaborators

• National Yang Ming Chiao Tung University: lead

Study Sites (1)

National Yang Ming Chiao Tung University

Taipei, Beitou Dist., 112, Taiwan

RECRUITING

Central Study Contacts

ChienYu Huang, Bachelor

CONTACT

+886-955-879163; chienyu.ns11@nycu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: March 24, 2024
• First Posted: April 17, 2024
• Study Start: April 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)