Antioxidant Bioavailability

Clinical Pilot Study on Antioxidant Uptake and Downstream Effects

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.

Study Overview

• Status: Recruiting
• Conditions: Pharmacokinetics
• Intervention / Treatment: Dietary supplement: Liposomal vitamin C, 1 gram; Dietary supplement: Liposomal vitamin C, 2 grams; Dietary supplement: Liposomal vitamin C, 5 grams; Dietary supplement: 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 Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gitte Jensen, PhD; Phone Number: 541-884-0112; Email: gitte@nislabs.com

Study Locations

• United States
  • Oregon
    • Klamath Falls, Oregon, United States, 97601
      • Recruiting
      • Gitte Jensen
      • Contact: Gitte S. Jensen, PhD; Phone Number: 541-884-0112; Email: gitte@nislabs.com
      • Principal Investigator: Gitte S. Jensen, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Liposomal vitamin C, 1 gram; Participants will consume 1 gram on study day	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
Active Comparator: Liposomal vitamin C, 2 grams; Participants will consume 2 grams on study day	Dietary supplement: Liposomal vitamin C, 2 grams; after a blood draw 2 grams of vitamin c will be consumed followed by 3 additional blood draws
Active Comparator: Liposomal vitamin C, 5 grams; Participants will consume 5 grams on study day	Dietary supplement: Liposomal vitamin C, 5 grams; after a blood draw 5 grams of vitamin c will be consumed followed by 3 additional blood draws
Placebo Comparator: Placebo; Participants will consume placebo on study day	Dietary supplement: Placebo; after a blood draw placebo will be consumed followed by 3 additional blood draws

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of vitamin C levels	HPLC (High performance liquid chromatography)	6 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of antioxidant status	FRAP (Ferric reducing antioxidant power) assay	6 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of downstream effects reflecting antioxidant protection	lipid peroxidation	6 hours

Collaborators and Investigators

• Sponsor: Natural Immune Systems Inc
• Investigators: Principal Investigator: Gitte Jensen, PhD, NIS Labs

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Anticipated): December 25, 2022
• Study Completion (Anticipated): June 25, 2023

Study Registration Dates

• First Submitted: July 3, 2020
• First Submitted That Met QC Criteria: July 3, 2020
• First Posted (Actual): July 9, 2020

Study Record Updates

• Last Update Posted (Actual): September 27, 2022
• Last Update Submitted That Met QC Criteria: September 26, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Antioxidants; Vitamins; Ascorbic Acid
• Other Study ID Numbers: NIS161-004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No