Antioxidant Bioavailability

NCT04463030 — Not applicable, Unknown, 24 participants, Natural Immune Systems Inc

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Clinical Pilot Study on Antioxidant Uptake and Downstream Effects

Registry	NCT04463030
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, crossover, masking: single, basic science
Enrollment	24 (Estimated)
Sponsor	Natural Immune Systems Inc (Other)
Conditions	Pharmacokinetics
Interventions	Liposomal vitamin C, 1 gram, Liposomal vitamin C, 2 grams, Liposomal vitamin C, 5 grams, Placebo (Dietary supplement)
Dates	start 2020-07-01, primary completion 2022-12-25 (estimated), completion 2023-06-25 (estimated), first posted 2020-07-09, last updated 2022-09-27
Locations	1 site in United States

-Summary

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.

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+Detailed 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.

+Arms and interventions

Arm	Type	Interventions	Description
Liposomal vitamin C, 1 gram	Active comparator	Dietary Supplement: Liposomal vitamin C, 1 gram	Participants will consume 1 gram on study day
Liposomal vitamin C, 2 grams	Active comparator	Dietary Supplement: Liposomal vitamin C, 2 grams	Participants will consume 2 grams on study day
Liposomal vitamin C, 5 grams	Active comparator	Dietary Supplement: Liposomal vitamin C, 5 grams	Participants will consume 5 grams on study day
Placebo	Placebo comparator	Dietary Supplement: Placebo	Participants will consume placebo on study day

Liposomal vitamin C, 1 gram (Dietary supplement): after a blood draw 1 gram of vitamin c will be consumed followed by 3 additional blood draws
Liposomal vitamin C, 2 grams (Dietary supplement): after a blood draw 2 grams of vitamin c will be consumed followed by 3 additional blood draws
Liposomal vitamin C, 5 grams (Dietary supplement): after a blood draw 5 grams of vitamin c will be consumed followed by 3 additional blood draws
Placebo (Dietary supplement): after a blood draw placebo will be consumed followed by 3 additional blood draws

+Outcome measures

Primary outcomes

Evaluation of vitamin C levels [6 hours]: HPLC (High performance liquid chromatography)

Secondary outcomes

Evaluation of antioxidant status [6 hours]: FRAP (Ferric reducing antioxidant power) assay

Other outcomes

Evaluation of downstream effects reflecting antioxidant protection [6 hours]: lipid peroxidation

+Eligibility

Sex: All, ages: 18 Years to 70 Years, 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.

+Locations (1)

Facility	City	Country	Status
Gitte Jensen	Klamath Falls, Oregon	United States	Recruiting

+Investigators

Gitte Jensen, PhD, Principal investigator, NIS Labs