The Effect of Liposome Vitamin C on the Absorption and Metabolism of the Human Body.

NCT ID: NCT04886752

Last Updated: 2021-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-10
• Study Completion Date: 2020-12-31

Brief Summary

To evaluate the difference between vitamin C in the form of oral liposomes and general vitamin C in a fixed period of time in plasma and urine.

Detailed Description

we recruited 11 healthy subjects and adopted a cross-over test. the subjects need to take 3 tests during trail. After each test was completed, a washout period of 14 days was required before the next test start. The subjects were informed to consume one sachet vitamin C without liposome, liposomal process A vitamin C, or liposomal process B vitamin C (Double Nutri™) every test, and vitamin C concentration was measured at baseline (0 hours), 0.5, 1, 2, 3, 4, and 8 hours after taking test sample.

Conditions

Vitamin C Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

vitamin C without liposome

vitamin C without liposome

Group Type: SHAM_COMPARATOR

vitamin C without liposome

Intervention Type: DIETARY_SUPPLEMENT

subjects need to take 3 tests during trail. After each test was completed, a washout period of 14 days was required before the next test start

liposomal process A vitamin C

liposomal process A vitamin C

Group Type: PLACEBO_COMPARATOR

liposomal process A vitamin C

Intervention Type: DIETARY_SUPPLEMENT

subjects need to take 3 tests during trail. After each test was completed, a washout period of 14 days was required before the next test start

liposomal process B vitamin C (Double Nutri™)

liposomal process B vitamin C (Double Nutri™)

Group Type: EXPERIMENTAL

liposomal process B vitamin C (Double Nutri™)

Intervention Type: DIETARY_SUPPLEMENT

subjects need to take 3 tests during trail. After each test was completed, a washout period of 14 days was required before the next test start

Interventions

vitamin C without liposome

subjects need to take 3 tests during trail. After each test was completed, a washout period of 14 days was required before the next test start

Intervention Type: DIETARY_SUPPLEMENT

liposomal process A vitamin C

subjects need to take 3 tests during trail. After each test was completed, a washout period of 14 days was required before the next test start

Intervention Type: DIETARY_SUPPLEMENT

liposomal process B vitamin C (Double Nutri™)

subjects need to take 3 tests during trail. After each test was completed, a washout period of 14 days was required before the next test start

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

1. Adults between 20-60 years old,

2. No heart, liver, kidney, endocrine and major organic diseases

Exclusion Criteria

1. Renal insufficiency and dialysis

2. Cancer

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

4. Take chronic disease drugs,

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

6. Too high fasting blood glucose ≧ 100 mg/dL,

7. Triglyceride ≧ 150 mg/dL,Total cholesterol ≧ 200 mg/dL,

8. Have a history of vitamin C allergy,

9. People with mental illness,

10. Pregnant or breastfeeding women,

11. Hematosis,

12. Kidney stones,

13. Long-term vitamin C 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

TCI Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jaw-Shiun Tsai, Doctor

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

Research & Design Center, TCI CO., Ltd

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

201903113RSA

Identifier Type: -

Identifier Source: org_study_id