Antioxidant Bioavailability

NCT ID: NCT04463030

Last Updated: 2022-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2023-06-25

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pharmacokinetics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomized, placebo-controlled, single blind, cross-over trial
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Investigators

Study Groups

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Liposomal vitamin C, 1 gram

Participants will consume 1 gram on study day

Group Type ACTIVE_COMPARATOR

Liposomal vitamin C, 1 gram

Intervention Type DIETARY_SUPPLEMENT

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

Liposomal vitamin C, 2 grams

Participants will consume 2 grams on study day

Group Type ACTIVE_COMPARATOR

Liposomal vitamin C, 2 grams

Intervention Type DIETARY_SUPPLEMENT

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

Liposomal vitamin C, 5 grams

Participants will consume 5 grams on study day

Group Type ACTIVE_COMPARATOR

Liposomal vitamin C, 5 grams

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Participants will consume placebo on study day

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Liposomal vitamin C, 1 gram

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

Intervention Type 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

Intervention Type 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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Natural Immune Systems Inc

OTHER

Sponsor Role lead

Responsible Party

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Gitte Jensen, Ph.D.

Research Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gitte Jensen, PhD

Role: PRINCIPAL_INVESTIGATOR

NIS Labs

Locations

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Gitte Jensen

Klamath Falls, Oregon, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Gitte Jensen, PhD

Role: CONTACT

541-884-0112

Facility Contacts

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Gitte S. Jensen, PhD

Role: primary

541-884-0112

Other Identifiers

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NIS161-004

Identifier Type: -

Identifier Source: org_study_id

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