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

NCT04886752 | Completed

• 1 other identifier: 201903113RSA
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin C Deficiency

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (3)

vitamin C without liposome

SHAM COMPARATOR

vitamin C without liposome

Dietary Supplement: vitamin C without liposome

liposomal process A vitamin C

PLACEBO COMPARATOR

liposomal process A vitamin C

Dietary Supplement: liposomal process A vitamin C

liposomal process B vitamin C (Double Nutri™)

EXPERIMENTAL

liposomal process B vitamin C (Double Nutri™)

Dietary Supplement: liposomal process B vitamin C (Double Nutri™)

Interventions

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

vitamin C without liposome

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 A vitamin C

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

liposomal process B vitamin C (Double Nutri™)

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• TCI Co., Ltd.: lead

Study Sites (1)

Research & Design Center, TCI CO., Ltd

Taipei, 114, Taiwan

Location

MeSH Terms

Conditions

Ascorbic Acid Deficiency

Interventions

Ascorbic Acid; Liposomes

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Membranes, Artificial; Biomedical and Dental Materials; Drug Carriers; Dosage Forms; Pharmaceutical Preparations; Manufactured Materials; Technology, Industry, and Agriculture; Biomimetic Materials

Study Officials

• Jaw-Shiun Tsai, Doctor

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2021
• First Posted: May 14, 2021
• Study Start: June 10, 2019
• Primary Completion: June 9, 2020
• Study Completion: December 31, 2020
• Last Updated: May 14, 2021

Record last verified: 2021-05

Locations

TW (1)