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Clinical Trials/NCT04886752
NCT04886752CompletedNot Applicable

The Effect of Liposome Vitamin C on the Absorption

TCI Co., Ltd.2 sites in 1 country11 target enrollmentStarted: June 10, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
11
Locations
2
Primary Endpoint
vitamin c detection

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
20 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

  • Renal insufficiency and dialysis
  • 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,
  • Kidney stones,
  • Long-term vitamin C supplements (at least 200 mg per day for more than one month)

Outcomes

Primary Outcomes

vitamin c detection

Time Frame: at 8 hours after taking test sample

vitamin c was assessed by Ascorbic Acid Colorimetric Assay Kit II

The change of Triglyceride

Time Frame: at 8 hours after taking test sample

Venous blood was sampled to measure concentrations of Triglyceride

The change of aspartate aminotransferase

Time Frame: 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 Frame: 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

Time Frame: at 8 hours after taking test sample

Venous blood was sampled to measure concentrations of alanine aminotransferase

The change of creatine

Time Frame: at 8 hours after taking test sample

Venous blood was sampled to measure concentrations of creatine

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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