PharmacokineticsNCT04463030
Antioxidant Bioavailability
A study testing Liposomal vitamin C, 1 gram, Liposomal vitamin C, 2 grams and Liposomal vitamin C, 5 grams in people with Pharmacokinetics, run by Natural Immune Systems Inc at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- Liposomal vitamin C, 1 gram, Liposomal vitamin C, 2 grams and Liposomal vitamin C, 5 grams
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2020to 25 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Gitte Jensen
Klamath Falls, Oregon, 97601
Gitte S. Jensen, PhD, 541-884-0112, gitte@nislabs.com
Gitte S. Jensen, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Pharmacokinetics
- Being tested
- Liposomal vitamin C, 1 gram, Liposomal vitamin C, 2 grams, Liposomal vitamin C, 5 grams, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal vitamin C, 1 gramDietary supplement
after a blood draw 1 gram of vitamin c will be consumed followed by 3 additional blood draws
Liposomal vitamin C, 2 gramsDietary supplement
after a blood draw 2 grams of vitamin c will be consumed followed by 3 additional blood draws
Liposomal vitamin C, 5 gramsDietary supplement
after a blood draw 5 grams of vitamin c will be consumed followed by 3 additional blood draws
PlaceboDietary supplement
after a blood draw placebo will be consumed followed by 3 additional blood draws
| Study group | Role | What they receive |
|---|---|---|
| Liposomal vitamin C, 1 gram | Active comparator | Participants will consume 1 gram on study day Receives: Dietary Supplement: Liposomal vitamin C, 1 gram |
| Liposomal vitamin C, 2 grams | Active comparator | Participants will consume 2 grams on study day Receives: Dietary Supplement: Liposomal vitamin C, 2 grams |
| Liposomal vitamin C, 5 grams | Active comparator | Participants will consume 5 grams on study day Receives: Dietary Supplement: Liposomal vitamin C, 5 grams |
| Placebo | Placebo comparator | Participants will consume placebo on study day Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of vitamin C levels
HPLC (High performance liquid chromatography)
Measured: 6 hours
Secondary outcomes (1)
Evaluation of antioxidant status
FRAP (Ferric reducing antioxidant power) assay
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start1 Jul 2020
- Primary completion25 Dec 2022 (estimated)
- Study completion25 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, placebo-controlled, single blind, cross-over trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Natural Immune Systems Inc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gitte Jensen, Ph.D., Natural Immune Systems Inc
- Investigators
- Gitte Jensen, PhD, Principal investigator, NIS Labs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04463030
- Sponsor's protocol ID
- NIS161-004
- Status last verified
- Sep 2022
- First submitted
- 3 Jul 2020
- Last updated
- 27 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Pilot Study on Antioxidant Uptake and Downstream Effects
- ClinicalTrials.gov ID
- NCT04463030
- Acronym / sponsor ID
- NIS161-004
- Conditions
- Pharmacokinetics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Natural Immune Systems IncUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 25 Dec 2022 (estimated)
- Study completion
- 25 Jun 2023 (estimated)
- First posted
- 9 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 4
- Model description
- Randomized, placebo-controlled, single blind, cross-over trial
| Arm | Type | Receives |
|---|---|---|
| Liposomal vitamin C, 1 gram | Active comparator | Dietary Supplement: Liposomal vitamin C, 1 gramParticipants will consume 1 gram on study day |
| Liposomal vitamin C, 2 grams | Active comparator | Dietary Supplement: Liposomal vitamin C, 2 gramsParticipants will consume 2 grams on study day |
| Liposomal vitamin C, 5 grams | Active comparator | Dietary Supplement: Liposomal vitamin C, 5 gramsParticipants will consume 5 grams on study day |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboParticipants will consume placebo on study day |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liposomal vitamin C, 1 gramafter a blood draw 1 gram of vitamin c will be consumed followed by 3 additional blood draws | Dietary supplement | Liposomal vitamin C, 1 gram |
| Liposomal vitamin C, 2 gramsafter a blood draw 2 grams of vitamin c will be consumed followed by 3 additional blood draws | Dietary supplement | Liposomal vitamin C, 2 grams |
| Liposomal vitamin C, 5 gramsafter a blood draw 5 grams of vitamin c will be consumed followed by 3 additional blood draws | Dietary supplement | Liposomal vitamin C, 5 grams |
| Placeboafter a blood draw placebo will be consumed followed by 3 additional blood draws | Dietary supplement | Placebo |
Primary outcome
Evaluation of vitamin C levels
Time frame: 6 hours
HPLC (High performance liquid chromatography)
1 secondary outcome
Evaluation of antioxidant status
Time frame: 6 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gitte Jensen, PhD principal investigator
NIS Labs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liposomal vitamin C, 1 gram, Liposomal vitamin C, 2 grams and Liposomal vitamin C, 5 grams in people with Pharmacokinetics, run by Natural Immune Systems Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gitte Jensen, PhD (541-884-0112, gitte@nislabs.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of vitamin C levels (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2022.