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

NCT04886752 — Not applicable, Completed, 11 participants, TCI Co., Ltd.

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The Effect of Liposome Vitamin C on the Absorption

RegistryNCT04886752
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, crossover, masking: double, treatment
Enrollment11 (Actual)
SponsorTCI Co., Ltd. (Industry)
ConditionsVitamin C Deficiency
Interventionsvitamin C without liposome, liposomal process A vitamin C, liposomal process B vitamin C (Double Nutri™) (Dietary supplement)
Datesstart 2019-06-10, primary completion 2020-06-09, completion 2020-12-31, first posted 2021-05-14, last updated 2021-05-14
Locations1 site in Taiwan

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All trials for Vitamin C Deficiency All trials of vitamin C without liposome All trials of liposomal process A vitamin C

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
vitamin C without liposomeSham comparatorDietary Supplement: vitamin C without liposomevitamin C without liposome
liposomal process A vitamin CPlacebo comparatorDietary Supplement: liposomal process A vitamin Cliposomal process A vitamin C
liposomal process B vitamin C (Double Nutri™)ExperimentalDietary Supplement: liposomal process B vitamin C (Double Nutri™)liposomal process B vitamin C (Double Nutri™)
  • 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

+Outcome measures

Primary outcomes

  • vitamin c detection [at 8 hours after taking test sample]: vitamin c was assessed by Ascorbic Acid Colorimetric Assay Kit II
  • The change of Triglyceride [at 8 hours after taking test sample]: Venous blood was sampled to measure concentrations of Triglyceride
  • The change of body mass index (BMI) [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 aspartate aminotransferase [at 8 hours after taking test sample]: Venous blood was sampled to measure concentrations of aspartate aminotransferase
  • The change of alanine aminotransferase [at 8 hours after taking test sample]: Venous blood was sampled to measure concentrations of alanine aminotransferase
  • The change of creatine [at 8 hours after taking test sample]: Venous blood was sampled to measure concentrations of creatine

+Eligibility

Sex: All, ages: 20 Years to 60 Years, accepts healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

+Locations (1)

FacilityCityCountryStatus
Research & Design Center, TCI CO., LtdTaipeiTaiwan

+Investigators

My Notes