Antioxidant Bioavailability

Study Overview
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Brief Summary
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A small cross-over trial on 3 different doses of liposomal vitamin C, comparing vitamin C uptake and downstream effects when 24 people consume 1, 2, and 5 grams on different test days, compared to placebo.

Detailed Description
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A randomized, cross-over study design will be used to evaluate the effects of consumption of 4 different doses of liposomal vitamin C (0, 1, 2, and 5 grams). The study is of 5 weeks' duration, with evaluation of a different dose at each of week 1, week 3 and week 5 with a one week washout between each dose.

Official Title
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Clinical Pilot Study on Antioxidant Uptake and Downstream Effects

Conditions
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Pharmacokinetics

Intervention / Treatment
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* Dietary Supplement: Liposomal vitamin C, 1 gram
* Dietary Supplement: Liposomal vitamin C, 2 grams
* Dietary Supplement: Liposomal vitamin C, 5 grams
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult people of either gender; BMI between 18.0 and 34.9 (inclusive); Willing to abstain from coffee, tea, and soft-drinks for at least one hour prior to a clinic visit; Willing to abstain from alcohol for at least 12 hours prior to a clinic visit; Willing to maintain a consistent habit of abstaining from exercising, tobacco use, and nutritional supplements on the morning of a study visit. Exclusion Criteria: Cancer during past 12 months; Chemotherapy during past 12 months; Significant active uncontrolled illness (such as lymphoma, liver disease, kidney failure, heart failure). Previous major surgery to stomach or intestines [(absorption of test product may be altered) minor surgery is not a problem, including appendix and gallbladder removal]; Currently taking nutritional supplements judged by the study coordinator to negate or camouflage the effects of the test product; Food allergies related to ingredients in test product; Women who are pregnant, nursing, or trying to become pregnant.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized, placebo-controlled, single blind, cross-over trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Liposomal vitamin C, 1 gram<br>Participants will consume 1 gram on study day | Dietary Supplement: Liposomal vitamin C, 1 gram<br>* after a blood draw 1 gram of vitamin c will be consumed followed by 3 additional blood draws<br>|
| Active Comparator: Liposomal vitamin C, 2 grams<br>Participants will consume 2 grams on study day | Dietary Supplement: Liposomal vitamin C, 2 grams<br>* after a blood draw 2 grams of vitamin c will be consumed followed by 3 additional blood draws<br>|
| Active Comparator: Liposomal vitamin C, 5 grams<br>Participants will consume 5 grams on study day | Dietary Supplement: Liposomal vitamin C, 5 grams<br>* after a blood draw 5 grams of vitamin c will be consumed followed by 3 additional blood draws<br>|
| Placebo Comparator: Placebo<br>Participants will consume placebo on study day | Dietary Supplement: Placebo<br>* after a blood draw placebo will be consumed followed by 3 additional blood draws<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of vitamin C levels | HPLC (High performance liquid chromatography) | 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of antioxidant status | FRAP (Ferric reducing antioxidant power) assay | 6 hours |