Comparison of Bioavailability of Liposomal and Traditional Formulation of Vitamin C

Study Overview
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Brief Summary
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The aim of the study was to compare the profiles of vitamin C serum concentration in healthy volunteers after the single oral administration either in a liposomal (Liposovit-C pure) or traditional formulation.

Detailed Description
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The randomized, double-blind, cross-over study was conducted under the supervision of physician on a group of 10 healthy subjects. The volunteers received 1g of vitamin C in a traditional formulation (powder in capsules), and after 14 days of a washout period 1 gram of Liposovit-C pure (liposomal formulation, powder in capsules). Venous blood was collected from each participant of the study immediately before the administration of a studied substance and 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 24 hours post the administration.

Official Title
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Comparison of Bioavailability of Liposomal and Traditional Formulation of Vitamin C

Conditions
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Bioavailability of Vitamin C

Intervention / Treatment
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* Dietary Supplement: Liposomal Vitamin C (Liposovit-C)
* Dietary Supplement: Traditional Vitamin C


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women and men, 18-65 years old. Signed informed consent. No injuries or hospitalizations within the last 3 months. Refraining from consuming any vitamin C supplements or foods enriched with vitamin C for a period of 72 hours. Limiting excessive consumption of red peppers, parsley (stalks), Brussels sprouts, broccoli, turnip, tomatoes, cabbage, spinach, watercress, citrus fruits, and citrus juices. Not taking acetylsalicylic acid (aspirin, polopiryna, etopiryna) during the study. Participants should fast for at least 8-12 hours prior to the administration of the preparations. Exclusion Criteria: Unwilling to give consent. Injuries within the last 3 months. Cancer (current or past). Renal dysfunction (eGFR < 60 ml/min). Gastrointestinal disorders (including use of antacids). Tobacco use in any form. Pregnancy/breastfeeding. Patient after organ transplantation, after a stroke, use of anticoagulants, use of immunosuppressants. Female patient receiving hormonal therapy (contraception).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liposomal Vitamin C (Liposovit-C)<br>Single oral dose of liposomal vitamin C formulation | Dietary Supplement: Liposomal Vitamin C (Liposovit-C)<br>* 1000 mg of ascorbic acid in liposomal formulation<br>|
| Active Comparator: Traditional Vitamin C<br>Single oral dose of traditional vitamin C formulation | Dietary Supplement: Traditional Vitamin C<br>* 1000 mg of ascorbic acid in traditional formulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total amount of ascorbic acid that has been absorbed, defined as AUC | Comparison of the bioavailability of formulations based on the total amount of ascorbic acid that has been absorbed, defined as AUC (area under the curve) | baseline, 30 minutes, 1, 2, 3, 4, 6, 8, 10, 24 hours post the administration | 
| Maximum concentration of ascorbic acid (Cmax) | Maximum concentration of ascorbic acid achieved in the blood after administration of both formulations | baseline, 30 minutes, 1, 2, 3, 4, 6, 8, 10, 24 hours post the administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of ascorbic acid after 24 hours (C24h) | Comparison of the concentration achieved in the blood after 24 hours (C24h) from the administration of both formulations | 24 hours post the administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liposovit-C, Ascorbic Acid, Liposomal Vitamin C