Antioxidant Bioavailability

Natural Immune Systems Inc24 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

Conditions

Pharmacokinetics

Interventions

Liposomal vitamin C, 1 gramDIETARY_SUPPLEMENT

after a blood draw 1 gram of vitamin c will be consumed followed by 3 additional blood draws

Liposomal vitamin C, 2 gramsDIETARY_SUPPLEMENT

after a blood draw 2 grams of vitamin c will be consumed followed by 3 additional blood draws

Liposomal vitamin C, 5 gramsDIETARY_SUPPLEMENT

after a blood draw 5 grams of vitamin c will be consumed followed by 3 additional blood draws

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Gitte Jensen

Klamath Falls, Oregon, United States

RECRUITING

Outcomes

Primary Outcomes

Evaluation of vitamin C levels

HPLC (High performance liquid chromatography)

Time frame: 6 hours

Secondary Outcomes

Evaluation of antioxidant status

FRAP (Ferric reducing antioxidant power) assay

Time frame: 6 hours

Central Contacts

Gitte Jensen, PhD

CONTACT

541-884-0112 gitte@nislabs.com

Data from ClinicalTrials.gov

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