Back to results

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

Primary Purpose

Vitamin C Deficiency

Status

Completed

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

vitamin C without liposome

liposomal process A vitamin C

liposomal process B vitamin C (Double Nutri™)

About this trial

This is an interventional treatment trial for Vitamin C Deficiency

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Adults between 20-60 years old,
No heart, liver, kidney, endocrine and major organic diseases

Exclusion Criteria:

Renal insufficiency and dialysis
Cancer
Underweight (BMI≦17) or obese (BMI≧27),
Take chronic disease drugs,
Blood pressure systolic blood pressure ≧130 mmHg or diastolic blood pressure ≧85 mmHg,
Too high fasting blood glucose ≧ 100 mg/dL,
Triglyceride ≧ 150 mg/dL,Total cholesterol ≧ 200 mg/dL,
Have a history of vitamin C allergy,
People with mental illness,
Pregnant or breastfeeding women,
Hematosis,
Kidney stones,
Long-term vitamin C supplements (at least 200 mg per day for more than one month)

Sites / Locations

Research & Design Center, TCI CO., Ltd

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Placebo Comparator

Experimental

Arm Label

vitamin C without liposome

liposomal process A vitamin C

liposomal process B vitamin C (Double Nutri™)

Arm Description

vitamin C without liposome

liposomal process A vitamin C

liposomal process B vitamin C (Double Nutri™)

Outcomes

Primary Outcome Measures

vitamin c detection

vitamin c was assessed by Ascorbic Acid Colorimetric Assay Kit II

The change of Triglyceride

Venous blood was sampled to measure concentrations of Triglyceride

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.

The change of aspartate aminotransferase

Venous blood was sampled to measure concentrations of aspartate aminotransferase

The change of alanine aminotransferase

Venous blood was sampled to measure concentrations of alanine aminotransferase

The change of creatine

Venous blood was sampled to measure concentrations of creatine

Secondary Outcome Measures

Full Information

NCT ID

NCT04886752

First Posted

May 9, 2021

Last Updated

May 13, 2021

Sponsor

TCI Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04886752

Brief Title

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

Official Title

The Effect of Liposome Vitamin C on the Absorption

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Completed

Study Start Date

June 10, 2019 (Actual)

Primary Completion Date

June 9, 2020 (Actual)

Study Completion Date

December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

TCI Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vitamin C Deficiency

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

vitamin C without liposome

Arm Type

Sham Comparator

Arm Description

vitamin C without liposome

Arm Title

liposomal process A vitamin C

Arm Type

Placebo Comparator

Arm Description

liposomal process A vitamin C

Arm Title

liposomal process B vitamin C (Double Nutri™)

Arm Type

Experimental

Arm Description

liposomal process B vitamin C (Double Nutri™)

Intervention Type

Dietary Supplement

Intervention Name(s)

vitamin C without liposome

Intervention Description

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

Intervention Name(s)

liposomal process A vitamin C

Intervention Description

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

Intervention Name(s)

liposomal process B vitamin C (Double Nutri™)

Intervention Description

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

Primary Outcome Measure Information:

Title

vitamin c detection

Description

vitamin c was assessed by Ascorbic Acid Colorimetric Assay Kit II

Time Frame

at 8 hours after taking test sample

Title

The change of Triglyceride

Description

Venous blood was sampled to measure concentrations of Triglyceride

Time Frame

at 8 hours after taking test sample

Title

The change of body mass index (BMI)

Description

Time Frame

Time 0, 0.5, 1, 2, 3, 4, and 8 hours after taking test sample

Title

The change of aspartate aminotransferase

Description

Venous blood was sampled to measure concentrations of aspartate aminotransferase

Time Frame

at 8 hours after taking test sample

Title

The change of alanine aminotransferase

Description

Venous blood was sampled to measure concentrations of alanine aminotransferase

Time Frame

at 8 hours after taking test sample

Title

The change of creatine

Description

Venous blood was sampled to measure concentrations of creatine

Time Frame

at 8 hours after taking test sample

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adults between 20-60 years old, No heart, liver, kidney, endocrine and major organic diseases Exclusion Criteria: Renal insufficiency and dialysis Cancer Underweight (BMI≦17) or obese (BMI≧27), Take chronic disease drugs, Blood pressure systolic blood pressure ≧130 mmHg or diastolic blood pressure ≧85 mmHg, Too high fasting blood glucose ≧ 100 mg/dL, Triglyceride ≧ 150 mg/dL,Total cholesterol ≧ 200 mg/dL, Have a history of vitamin C allergy, People with mental illness, Pregnant or breastfeeding women, Hematosis, Kidney stones, Long-term vitamin C supplements (at least 200 mg per day for more than one month)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jaw-Shiun Tsai, Doctor

Organizational Affiliation

National Taiwan University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Research & Design Center, TCI CO., Ltd

City

Taipei

ZIP/Postal Code

114

Country

Taiwan

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs