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临床试验/NCT04886752
NCT04886752已完成不适用

The Effect of Liposome Vitamin C on the Absorption

TCI Co., Ltd.2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2019年6月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
TCI Co., Ltd.
入组人数
11
试验地点
2
主要终点
vitamin c detection

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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)

结局指标

主要结局

vitamin c detection

时间窗: at 8 hours after taking test sample

vitamin c was assessed by Ascorbic Acid Colorimetric Assay Kit II

The change of Triglyceride

时间窗: at 8 hours after taking test sample

Venous blood was sampled to measure concentrations of Triglyceride

The change of aspartate aminotransferase

时间窗: at 8 hours after taking test sample

Venous blood was sampled to measure concentrations of aspartate aminotransferase

The change of body mass index (BMI)

时间窗: 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

时间窗: at 8 hours after taking test sample

Venous blood was sampled to measure concentrations of alanine aminotransferase

The change of creatine

时间窗: at 8 hours after taking test sample

Venous blood was sampled to measure concentrations of creatine

次要结局

未报告次要终点

研究者

发起方
TCI Co., Ltd.
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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