Immune SurveillanceNCT05431751
Clinical Proof-of-concept Study on Immune Surveillance and Alertness
A study testing Whole Algae in people with Immune Surveillance, run by Natural Immune Systems Inc at 1 site in United States.
Trial summary
Clinical proof-of-concept study comparing the acute. effects of an algae-based dietary supplement on immune surveillance and alertness. This study involves twenty-four participants composed of healthy adults, who will be taking either a placebo or supplement at different times. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Immune Surveillance
- What is being tested?
- Whole Algae
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jul 2022to Oct 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults
- Veins easy to see in both arms
- Willing to comply with a 24-hours wash-out period for vitamins and nutritional supplements
- Willing to comply with study procedures, including maintaining a consistent diet and lifestyle routine throughout the study. Consistent habit of bland breakfasts on days of clinic visits, abstaining from exercising, tobacco use, and nutritional supplements on the morning of a study visit, abstaining from use of coffee, tea, and soft-drinks for at least one hour prior to a clinic visit
- Willing to abstain from music, candy, gum, computer/cellphone use during clinic visits
Who cannot join
- Previous major gastrointestinal surgery (absorption of test product may be altered) (minor surgery not a problem, including previous removal of appendix and gall bladder)
- Taking anti-inflammatory medications on a daily basis (81 mg aspirin is acceptable)
- Vaccination during past 2 weeks
- Currently experiencing intense stressful events/ life changes
- Currently in intensive athletic training (such as marathon runners)
- Currently taking antipsychotic medications such as clozapine, Risperdal, Abilify, Zyprexa or Seroquel
Show all 12Show fewer
- An unusual sleep routine (examples: working graveyard shift, irregular routine with frequent late nights)
- Unwilling to maintain a constant intake of supplements over the duration of the study
- Anxiety about having blood drawn
- People of childbearing potential: Pregnant, nursing, or trying to become pregnant
- Known food allergies or sensitivities related to the test product or placebo
- Prescription medication will be evaluated on a case-by-case basis
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
NIS Labs
Klamath Falls, Oregon, 97601
Gitte Jensen, PhD, 541-882-0112, gitte@nislabs.com
Alex Cruickshank, Alex@nislabs.com
About this study
Clinical proof-of-concept study comparing the acute. effects of an algae-based dietary supplement on immune surveillance and alertness. This study involves twenty-four participants composed of healthy adults, who will be taking either a placebo or supplement at different times. Testing for immune status, cytokine levels, and immune responsiveness will be conducted to determine the acute impact of the supplement on immune function compared to a placebo.
Long term effects and lingering effects will be tested using the same parameters, following a consumption period of one week, as well as a washout period of one week.
Read the detailed description
Clinical-proof-of-concept study comparing the acute immune effects as well as the lasting and lingering effects of a dietary supplement, and a placebo. The dietary supplement is composed of whole Euglena gracilis algae, produced using a proprietary fermentation technique.
24 subjects will participate in a placebo-controlled, double-blinded, cross-over study design, wherein they will be taking placebo, or dietary supplement each separated by a 1-week washout period to evaluate rapid effects. Following which the subjects will also be taking placebo or dietary supplement continuously for 1 week each, to evaluate the long term and lingering effects.
For acute evaluation, blood samples are taken 1 hour after participants arrive, the dose is then administered. Samples are take 1 hour and 2 hours following administration. For long-term and lingering evaluation, blood samples are taken 1 hour after participants arrive. At all blood sample collections, a spit sample will also be taken for salivary IgA testing.
A series of immune panels will be used to determine the acute impacts on immune surveillance, immune cell activation status, immune cell priming, and cytokine profiles. Ex vivo immune challenges and salivary IgA testing will be used to determine the direct impacts on immune cells.
- Conditions
- Immune Surveillance
- Being tested
- Whole Algae
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole AlgaeDietary supplement
Whole Euglena gracilis algae, produced by proprietary fermentation.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group A | Experimental | Crossover study: Participants will be consuming placebo on a clinic day at least 1 week prior to a clinic day where they will consume the active intervention. Following the second clinic day, the participant will consume active intervention for 7 days. The participant will then undergo a washout period of 7 days. Receives: Dietary Supplement: Whole Algae |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune Surveillance and Alerness
Observation of changes in immune cell trafficking and status of immune cell alertness, ie. the changes in immune cell populations and activation following administration.
Measured: 2 hours, 1 week
Secondary outcomes (1)
Immune communication
Observation of changes in serum cytokine levels
Measured: 2 hours, 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start12 Jul 2022
- Primary completion31 Oct 2022
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune SurveillanceStudies 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
- Not applicable
- Intervention model
- Crossover
- Model description
- Placebo-controlled, cross-over study design
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Natural Immune Systems Inc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05431751
- Sponsor's protocol ID
- 153-012
- Status last verified
- Aug 2022
- First submitted
- 20 Jun 2022
- Last updated
- 7 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Proof-of-concept Study on Immune Surveillance and Alertness
- ClinicalTrials.gov ID
- NCT05431751
- Acronym / sponsor ID
- 153-012
- Conditions
- Immune Surveillance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Natural Immune Systems IncUniversity, hospital or other
- Study start
- 12 Jul 2022 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- Oct 2023 (estimated)
- First posted
- 24 Jun 2022 (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.
Clinical proof-of-concept study comparing the acute. effects of an algae-based dietary supplement on immune surveillance and alertness. This study involves twenty-four participants composed of healthy adults, who will be taking either a placebo or supplement at different times. Testing for immune status, cytokine levels, and immune responsiveness will be conducted to determine the acute impact of the supplement on immune function compared to a placebo.
Long term effects and lingering effects will be tested using the same parameters, following a consumption period of one week, as well as a washout period of one week.
Detailed description
Clinical-proof-of-concept study comparing the acute immune effects as well as the lasting and lingering effects of a dietary supplement, and a placebo. The dietary supplement is composed of whole Euglena gracilis algae, produced using a proprietary fermentation technique.
24 subjects will participate in a placebo-controlled, double-blinded, cross-over study design, wherein they will be taking placebo, or dietary supplement each separated by a 1-week washout period to evaluate rapid effects. Following which the subjects will also be taking placebo or dietary supplement continuously for 1 week each, to evaluate the long term and lingering effects.
For acute evaluation, blood samples are taken 1 hour after participants arrive, the dose is then administered. Samples are take 1 hour and 2 hours following administration. For long-term and lingering evaluation, blood samples are taken 1 hour after participants arrive. At all blood sample collections, a spit sample will also be taken for salivary IgA testing.
A series of immune panels will be used to determine the acute impacts on immune surveillance, immune cell activation status, immune cell priming, and cytokine profiles. Ex vivo immune challenges and salivary IgA testing will be used to determine the direct impacts on immune cells.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Placebo-controlled, cross-over study design
| Arm | Type | Receives |
|---|---|---|
| Experimental Group A | Experimental | Dietary Supplement: Whole AlgaeCrossover study: Participants will be consuming placebo on a clinic day at least 1 week prior to a clinic day where they will consume the active intervention. Following the second clinic day, the participant will consume active intervention for 7 days. The participant will then undergo a washout period of 7 days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy adults
- Veins easy to see in both arms
- Willing to comply with a 24-hours wash-out period for vitamins and nutritional supplements
- Willing to comply with study procedures, including maintaining a consistent diet and lifestyle routine throughout the study. Consistent habit of bland breakfasts on days of clinic visits, abstaining from exercising, tobacco use, and nutritional supplements on the morning of a study visit, abstaining from use of coffee, tea, and soft-drinks for at least one hour prior to a clinic visit
- Willing to abstain from music, candy, gum, computer/cellphone use during clinic visits
Key exclusion criteria (12 listed)
- Previous major gastrointestinal surgery (absorption of test product may be altered) (minor surgery not a problem, including previous removal of appendix and gall bladder)
- Taking anti-inflammatory medications on a daily basis (81 mg aspirin is acceptable)
- Vaccination during past 2 weeks
- Currently experiencing intense stressful events/ life changes
- Currently in intensive athletic training (such as marathon runners)
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 |
|---|---|---|
| Whole AlgaeWhole Euglena gracilis algae, produced by proprietary fermentation. | Dietary supplement | Experimental Group A |
Primary outcome
Immune Surveillance and Alerness
Time frame: 2 hours, 1 week
Observation of changes in immune cell trafficking and status of immune cell alertness, ie. the changes in immune cell populations and activation following administration.
1 secondary outcome
Immune communication
Time frame: 2 hours, 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole Algae in people with Immune Surveillance, 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 12 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 7 Aug 2023. 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. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immune Surveillance and Alerness (time frame: 2 hours, 1 week). 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 7 Aug 2023.