Recruiting

Liposomal Vitamin C

Sponsor:

Natural Immune Systems Inc

Code:

NCT04463030

Conditions

Pharmacokinetics

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Interventions

Liposomal vitamin C, 1 gram

Liposomal vitamin C, 2 grams

Liposomal vitamin C, 5 grams

Placebo

Study Details

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.

Conditions

Pharmacokinetics

Study ID

NCT04463030

Start date

Jul 1, 2020

Status verified date

Sep, 2022

Completion date

Jun 25, 2023

Anticipated

Primary completion date

Dec 25, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

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

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: Liposomal vitamin C, 1 gram

Participants will consume 1 gram on study day

active comparator: Liposomal vitamin C, 2 grams

Participants will consume 2 grams on study day

active comparator: Liposomal vitamin C, 5 grams

Participants will consume 5 grams on study day

placebo comparator: Placebo

Participants will consume placebo on study day

Interventions

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

Primary outcome measure

  • Evaluation of vitamin C levels [ Time Frame: 6 hours ]

Central Contacts and Locations

Central contacts

Gitte Jensen, PhD

541-884-0112gitte@nislabs.com

Locations

Gitte Jensen

Recruiting

Klamath Falls, Oregon, United States, 97601

Contacts

Gitte S. Jensen, PhD

541-884-0112gitte@nislabs.com

Principal Investigator:

Gitte S. Jensen, PhD

More Information

Sponsor

Natural Immune Systems Inc

Last update posted

Sep 27, 2022

Last verified

Sep, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Natural Immune Systems Inc on 2022-09-27.