The Effect of Liposome Vitamin C on the Absorption
| Registry | NCT04886752 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, crossover, masking: double, treatment |
| Enrollment | 11 (Actual) |
| Sponsor | TCI Co., Ltd. (Industry) |
| Conditions | Vitamin C Deficiency |
| Interventions | vitamin C without liposome, liposomal process A vitamin C, liposomal process B vitamin C (Double Nutri™) (Dietary supplement) |
| Dates | start 2019-06-10, primary completion 2020-06-09, completion 2020-12-31, first posted 2021-05-14, last updated 2021-05-14 |
| Locations | 1 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
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| vitamin C without liposome | Sham comparator | Dietary Supplement: vitamin C without liposome | vitamin C without liposome |
| liposomal process A vitamin C | Placebo comparator | Dietary Supplement: liposomal process A vitamin C | liposomal process A vitamin C |
| liposomal process B vitamin C (Double Nutri™) | Experimental | Dietary Supplement: liposomal process B vitamin C (Double Nutri™) | liposomal process B vitamin C (Double Nutri™) |
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)
| Facility | City | Country | Status |
|---|---|---|---|
| Research & Design Center, TCI CO., Ltd | Taipei | Taiwan |