Antioxidant Bioavailability

Pharmacokinetics Clinical Trial

Official title:

Clinical Pilot Study on Antioxidant Uptake and Downstream Effects

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04463030
• Other study ID #: NIS161-004
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: June 25, 2023

Study information

• Verified date: September 2022
• Source: Natural Immune Systems Inc
• Contact: Gitte Jensen, PhD
• Phone: 541-884-0112
• Email: gitte[@]nislabs.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: June 25, 2023
• Est. primary completion date: December 25, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pharmacokinetics

Intervention

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

Locations

Country	Name	City	State
United States	Gitte Jensen	Klamath Falls	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Natural Immune Systems Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Evaluation of downstream effects reflecting antioxidant protection	lipid peroxidation	6 hours
Primary	Evaluation of vitamin C levels	HPLC (High performance liquid chromatography)	6 hours
Secondary	Evaluation of antioxidant status	FRAP (Ferric reducing antioxidant power) assay	6 hours