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

The Effect of Liposome Vitamin C on the Absorption

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.

Study Overview

• Status: Completed
• Conditions: Vitamin C Deficiency
• Intervention / Treatment: Dietary supplement: vitamin C without liposome; Dietary supplement: liposomal process A vitamin C; Dietary supplement: liposomal process B vitamin C (Double Nutri™)

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 Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 114
    • Research & Design Center, TCI CO., Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: vitamin C without liposome	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
Placebo Comparator: liposomal process A vitamin C	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
Experimental: liposomal process B vitamin C (Double Nutri™)	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
vitamin c detection	vitamin c was assessed by Ascorbic Acid Colorimetric Assay Kit II	at 8 hours after taking test sample
The change of Triglyceride	Venous blood was sampled to measure concentrations of Triglyceride	at 8 hours after taking test sample
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
The change of aspartate aminotransferase	Venous blood was sampled to measure concentrations of aspartate aminotransferase	at 8 hours after taking test sample
The change of alanine aminotransferase	Venous blood was sampled to measure concentrations of alanine aminotransferase	at 8 hours after taking test sample
The change of creatine	Venous blood was sampled to measure concentrations of creatine	at 8 hours after taking test sample

Collaborators and Investigators

• Sponsor: TCI Co., Ltd.
• Investigators: Principal Investigator: Jaw-Shiun Tsai, Doctor, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2019
• Primary Completion (Actual): June 9, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: May 9, 2021
• First Submitted That Met QC Criteria: May 13, 2021
• First Posted (Actual): May 14, 2021

Study Record Updates

• Last Update Posted (Actual): May 14, 2021
• Last Update Submitted That Met QC Criteria: May 13, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hematologic Diseases; Nutrition Disorders; Hemorrhagic Disorders; Hemostatic Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Scurvy; Ascorbic Acid Deficiency; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Antioxidants; Vitamins; Vitamin B Complex; Ascorbic Acid
• Other Study ID Numbers: 201903113RSA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No