Antioxidant Bioavailability

Not Applicable

Recruiting

• Conditions: Pharmacokinetics
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Liposomal vitamin C, 1 gram; Dietary Supplement: Liposomal vitamin C, 2 grams; Dietary Supplement: Liposomal vitamin C, 5 grams

• Registration Number: NCT04463030
• Lead Sponsor: Natural Immune Systems Inc

Brief 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.

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.

Study Timeline

• Study Start: 2020-07-01
• Study First Submitted: 2020-07-03
• Study First Submitted QC: 2020-07-03
• Study First Posted: 2020-07-09
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-26
• Last Update Posted: 2022-09-27
• Primary Completion: 2022-12-25
• Study Completion: 2023-06-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants will consume placebo on study day
Liposomal vitamin C, 1 gram	Liposomal vitamin C, 1 gram	Participants will consume 1 gram on study day
Liposomal vitamin C, 2 grams	Liposomal vitamin C, 2 grams	Participants will consume 2 grams on study day
Liposomal vitamin C, 5 grams	Liposomal vitamin C, 5 grams	Participants will consume 5 grams on study day

Primary Outcome Measures

Name	Time	Method
Evaluation of vitamin C levels	6 hours	HPLC (High performance liquid chromatography)

Secondary Outcome Measures

Name	Time	Method
Evaluation of antioxidant status	6 hours	FRAP (Ferric reducing antioxidant power) assay

Trial Locations

Locations (1)

Gitte Jensen; 🇺🇸 Klamath Falls, Oregon, United States