Antioxidant Bioavailability

Natural Immune Systems

Status: Enrolling

Conditions: Pharmacokinetics

Treatments: Dietary Supplement: Liposomal vitamin C, 2 grams; Dietary Supplement: Liposomal vitamin C, 1 gram; Dietary Supplement: Liposomal vitamin C, 5 grams; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04463030

NIS161-004

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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24 participants in 4 patient groups, including a placebo group

Liposomal vitamin C, 1 gram

Active Comparator group

Description:

Participants will consume 1 gram on study day

Treatment:

Dietary Supplement: Liposomal vitamin C, 1 gram

Liposomal vitamin C, 2 grams

Active Comparator group

Description:

Participants will consume 2 grams on study day

Treatment:

Dietary Supplement: Liposomal vitamin C, 2 grams

Liposomal vitamin C, 5 grams

Active Comparator group

Description:

Participants will consume 5 grams on study day

Treatment:

Dietary Supplement: Liposomal vitamin C, 5 grams

Placebo

Placebo Comparator group

Description:

Participants will consume placebo on study day

Treatment:

Dietary Supplement: Placebo