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

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Liposome Vitamin C on the Absorption

Conditions
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Vitamin C Deficiency

Intervention / Treatment
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* Dietary Supplement: vitamin C without liposome
* Dietary Supplement: liposomal process A vitamin C
* Dietary Supplement: liposomal process B vitamin C (Double Nutri™)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: vitamin C without liposome<br>vitamin C without liposome | Dietary Supplement: vitamin C without liposome<br>* 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<br>|
| Placebo Comparator: liposomal process A vitamin C<br>liposomal process A vitamin C | Dietary Supplement: liposomal process A vitamin C<br>* 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<br>|
| Experimental: liposomal process B vitamin C (Double Nutri™)<br>liposomal process B vitamin C (Double Nutri™) | Dietary Supplement: liposomal process B vitamin C (Double Nutri™)<br>* 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<br>|

What is the study measuring?
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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 |