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TCI Co.

Ltd

Effects of liposomal encapsulation on vitamin C


absorption and metabolism

Executive Unit: National Taiwan University Hospital

Client: TCI CO., LTD

Principal Investigator: Dr. Jaw-Shiun Tsai


TCI Co., Ltd
EVE Lab
Efficacy, Value, Experience

Report No. 2020E03004 1

Highly confidential document, do not disclose unless authorized by TCI Co., Ltd. Copyrights reserved.
TCI Co., Ltd
EVE Lab
Efficacy, Value, Experience

IRB Certification of Approval

Report No. 2020E03004 2

Highly confidential document, do not disclose unless authorized by TCI Co., Ltd. Copyrights reserved.
TCI Co., Ltd
EVE Lab
Efficacy, Value, Experience
1. Preface
The purpose of the study is to evaluate the oral delivery efficacy of

liposomal-encapsulated vitamin C via clinical trial.

2. Materials and Methods


2.1 Sample and Dosage
2.1.1 Lipo Vit C: 1000 mg Vitamin C

2.1.2 Non-Lipo Vit C: 1000 mg Vitamin C

2.2 Subject selection


2.2.1 Number of subjects

11 subjects

2.2.2 Inclusion criteria

Healthy adults aged 20-60 years old (without heart, liver, kidney,

endocrine and other major organic diseases)

2.2.3 Exclusion criteria

(1) Renal disease patient

(2) Cancer patient

(3) Underweight (BMI ≦ 17) or obesity (BMI ≧ 27)

(4) People who take drugs for chronic diseases

(5) Systolic blood pressure ≧130 mmHg or diastolic blood

pressure ≧85 mmHg

(6) Glucose AC ≧ 100 mg/dL

(7) Triglyceride ≧ 150 mg/dL、Total-Cholesterol ≧ 200 mg/dL

(8) Vitamin C allergic reaction

(9) People with mental illness

Report No. 2020E03004 3

Highly confidential document, do not disclose unless authorized by TCI Co., Ltd. Copyrights reserved.
TCI Co., Ltd
EVE Lab
Efficacy, Value, Experience
(10) Female who is pregnant or nursing

(11) People with hemochromatosis

(12) People with calculus of kidney

(13) People who take vitamin C as a supplement for a long time (at

least 200 mg per day, maintain for more than a month)

2.3 Study design


This study adopts a two-stage design. Subjects need to participate in a total

of 2 tests after joining the trial. After each test is completed, an interval of 14 days

(wash-out period) is required before the next test can be performed (1st test→

wash-out 14 days→ 2nd test). Subjects must fast for 8 hours before testing. The

plasma vitamin C concentration is measured at baseline (0 hours) and 0.5, 1, 2, 3,

4, and 8 hours after ingestion of the test sample.

The values of results are expressed as Mean ± SD. A student t-test is

performed to assess the difference. Differences with p < 0.05 are considered

statistically significant. The study flow chart is as follows:

Report No. 2020E03004 4

Highly confidential document, do not disclose unless authorized by TCI Co., Ltd. Copyrights reserved.
TCI Co., Ltd
EVE Lab
Efficacy, Value, Experience

2.4 Test item


Plasma concentrations of vitamin C

3. Results
A total of 10 subjects have completed the trial. The subjects were informed to

consume one sachet Lipo Vit C or Non-Lipo Vit C every test. During the trial,

there were no any discomforts reported by the subjects.

The circulating concentration of vitamin C in plasma before and after

consuming the test sample is shown in Figure 1. The vitamin C concentrations of

the Lipo Vit C group were higher than the Non-Lipo Vit C group, which showed

that Lipo Vit C has better bioavailability and can last up in the body to 8 hours.

The area under the curve (line chart) of vitamin C content in plasma before

Report No. 2020E03004 5

Highly confidential document, do not disclose unless authorized by TCI Co., Ltd. Copyrights reserved.
TCI Co., Ltd
EVE Lab
Efficacy, Value, Experience
and after consuming 8 hours was calculated according to Figure 1. The AUC of

Lipo Vit C is 86.29 g×hr/mL and the AUC of Non-Lipo Vit C is 37.08 g×hr/mL

(Figure 2). The bioavailability of Lipo Vit C was higher than Non-Lipo Vit C by

133%. Calculation formula=[(86.29-37.08)/37.08]×100%=133%.

The results showed that liposomal encapsulation technology can enhance the

bioavailability of vitamin C.

4. Conclusion
The vitamin C concentrations in plasma of Lipo Vit C group after the

liposomal encapsulation technology was higher than the Non-Lipo Vit C group,

which showed that Lipo Vit C has better bioavailability and provides the

supplementary benefit of vitamin C.

Report No. 2020E03004 6

Highly confidential document, do not disclose unless authorized by TCI Co., Ltd. Copyrights reserved.
TCI Co., Ltd
EVE Lab
Efficacy, Value, Experience
Lipo Vit C (1000 mg Vit C)
Non-Lipo Vit C (1000 mg Vit C)
20.0
Plasma Vitamin C (g/mL)

** **
15.0 **
* *
* * *
10.0
* *

5.0 *

0.0
0 0.5 1 2 3 4 5 6 7 8
Time (Hour)
-5.0

Figure 1. Changes in the concentrations of vitamin C in plasma at various time


points before (time = 0 hour) and after consuming the test sample. (Comparison of
Lipo Vit C and Non-Lipo Vit C at each time point: **p<0.01; *p<0.05)

100.00
Area Under Curve (g×hr/mL)

80.00

60.00

40.00 86.29

20.00 37.08

0.00
Lipo Vit C Non-Lipo Vit C
(1000 mg Vit C) (1000 mg Vit C)

Figure 2. The plasma concentration-time curve of vitamin C before (time = 0 hour)


and after consuming the test sample.

Report No. 2020E03004 7

Highly confidential document, do not disclose unless authorized by TCI Co., Ltd. Copyrights reserved.

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