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

Not Applicable

Completed

• Conditions: Vitamin C Deficiency
• Interventions: Dietary Supplement: liposomal process A vitamin C; Dietary Supplement: liposomal process B vitamin C (Double Nutri™); Dietary Supplement: vitamin C without liposome

• Registration Number: NCT04886752
• Lead Sponsor: TCI Co., Ltd.

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.

Study Timeline

• Study Start: 2019-06-10
• Primary Completion: 2020-06-09
• Study Completion: 2020-12-31
• Status Verified: 2021-05
• Study First Submitted: 2021-05-09
• Study First Submitted QC: 2021-05-13
• Last Update Submitted: 2021-05-13
• Study First Posted: 2021-05-14
• Last Update Posted: 2021-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
liposomal process A vitamin C	liposomal process A vitamin C	liposomal process A vitamin C
liposomal process B vitamin C (Double Nutri™)	liposomal process B vitamin C (Double Nutri™)	liposomal process B vitamin C (Double Nutri™)
vitamin C without liposome	vitamin C without liposome	vitamin C without liposome

Primary Outcome Measures

Name	Time	Method
vitamin c detection	at 8 hours after taking test sample	vitamin c was assessed by Ascorbic Acid Colorimetric Assay Kit II
The change of Triglyceride	at 8 hours after taking test sample	Venous blood was sampled to measure concentrations of Triglyceride
The change of aspartate aminotransferase	at 8 hours after taking test sample	Venous blood was sampled to measure concentrations of aspartate aminotransferase
The change of body mass index (BMI)	Time 0, 0.5, 1, 2, 3, 4, and 8 hours after taking test sample	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.
The change of alanine aminotransferase	at 8 hours after taking test sample	Venous blood was sampled to measure concentrations of alanine aminotransferase
The change of creatine	at 8 hours after taking test sample	Venous blood was sampled to measure concentrations of creatine

Trial Locations

Locations (1)

Research & Design Center, TCI CO., Ltd; 🇨🇳 Taipei, Taiwan