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

Vitamin C Deficiency Clinical Trial

Official title:

The Effect of Liposome Vitamin C on the Absorption

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04886752
• Other study ID #: 201903113RSA
• Status: Completed
• Phase: N/A
• Start date: June 10, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: May 2021
• Source: TCI Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: December 31, 2020
• Est. primary completion date: June 9, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Ascorbic Acid Deficiency
• Scurvy
• Vitamin C Deficiency

Intervention

Dietary Supplement:
• 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
• 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
• 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

Locations

Country	Name	City	State
Taiwan	Research & Design Center, TCI CO., Ltd	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
TCI Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	vitamin c detection	vitamin c was assessed by Ascorbic Acid Colorimetric Assay Kit II	at 8 hours after taking test sample
Primary	The change of Triglyceride	Venous blood was sampled to measure concentrations of Triglyceride	at 8 hours after taking test sample
Primary	The change of body mass index (BMI)	BMI is a measurement of a person's leanness or corpulence based on their height and weight, and is intended to quantify tissue mass.The body mass index (BMI, kg/m^2) and body mass (kg) were assessed by InBody770.	Time 0, 0.5, 1, 2, 3, 4, and 8 hours after taking test sample
Primary	The change of aspartate aminotransferase	Venous blood was sampled to measure concentrations of aspartate aminotransferase	at 8 hours after taking test sample
Primary	The change of alanine aminotransferase	Venous blood was sampled to measure concentrations of alanine aminotransferase	at 8 hours after taking test sample
Primary	The change of creatine	Venous blood was sampled to measure concentrations of creatine	at 8 hours after taking test sample