Antioxidant Bioavailability

NCT04463030 | Unknown

• 1 other identifier: NIS161-004
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Evaluation of vitamin C levels

  HPLC (High performance liquid chromatography)

  6 hours

Secondary Outcomes (1)

• Evaluation of antioxidant status

  6 hours

Other Outcomes (1)

• Evaluation of downstream effects reflecting antioxidant protection

  6 hours

Study Arms (4)

Liposomal vitamin C, 1 gram

ACTIVE COMPARATOR

Participants will consume 1 gram on study day

Dietary Supplement: Liposomal vitamin C, 1 gram

Liposomal vitamin C, 2 grams

ACTIVE COMPARATOR

Participants will consume 2 grams on study day

Dietary Supplement: Liposomal vitamin C, 2 grams

Liposomal vitamin C, 5 grams

ACTIVE COMPARATOR

Participants will consume 5 grams on study day

Dietary Supplement: Liposomal vitamin C, 5 grams

Placebo

PLACEBO COMPARATOR

Participants will consume placebo on study day

Dietary Supplement: Placebo

Interventions

Liposomal vitamin C, 1 gram DIETARY_SUPPLEMENT

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

Liposomal vitamin C, 1 gram

Liposomal vitamin C, 2 grams DIETARY_SUPPLEMENT

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

Liposomal vitamin C, 2 grams

Liposomal vitamin C, 5 grams DIETARY_SUPPLEMENT

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

Liposomal vitamin C, 5 grams

Placebo DIETARY_SUPPLEMENT

after a blood draw placebo will be consumed followed by 3 additional blood draws

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Natural Immune Systems Inc: lead

Study Sites (1)

Gitte Jensen

Klamath Falls, Oregon, 97601, United States

RECRUITING

Study Officials

• Gitte Jensen, PhD

  NIS Labs

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gitte Jensen, PhD

CONTACT

541-884-0112; gitte@nislabs.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Director

Model Details: Randomized, placebo-controlled, single blind, cross-over trial

Study Record Dates

• First Submitted: July 3, 2020
• First Posted: July 9, 2020
• Study Start: July 1, 2020
• Primary Completion: December 25, 2022
• Study Completion: June 25, 2023
• Last Updated: September 27, 2022

Record last verified: 2022-09

Locations

US (1)