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Completed

NCT Number: NCT04886752

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

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.

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Key information

Conditions

Vitamin C Deficiency Ascorbic Acid Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Research & Design Center, TCI CO., Ltd

Taipei, 114, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

vitamin C without liposome

Dietary Supplement

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

liposomal process A vitamin C

Dietary Supplement

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

liposomal process B vitamin C (Double Nutri™)

Dietary Supplement

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 outcomes

  1. vitamin c detection

    Time frame: at 8 hours after taking test sample

    vitamin c was assessed by Ascorbic Acid Colorimetric Assay Kit II

  2. The change of Triglyceride

    Time frame: at 8 hours after taking test sample

    Venous blood was sampled to measure concentrations of Triglyceride

  3. 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.

  4. The change of aspartate aminotransferase

    Time frame: at 8 hours after taking test sample

    Venous blood was sampled to measure concentrations of aspartate aminotransferase

  5. The change of alanine aminotransferase

    Time frame: at 8 hours after taking test sample

    Venous blood was sampled to measure concentrations of alanine aminotransferase

  6. The change of creatine

    Time frame: at 8 hours after taking test sample

    Venous blood was sampled to measure concentrations of creatine

Sponsors and collaborators

Lead sponsor

TCI Co., Ltd.

Industry

Registry information

Official study title

The Effect of Liposome Vitamin C on the Absorption

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 14, 2021
Registry last updated
May 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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