Immune SurveillanceNCT05364710
Clinical Proof-of-concept Study on Rapid Immune Modulating Effects
A study testing Transfer factor from colostrum ultrafiltrate 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 immune impacts of of 2 doses of a novel blend of supplements to a placebo. This study involves twenty-four participants, composed of healthy adults, who will be taking a placebo and 2 different doses of the blend 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?
- Transfer factor from colostrum ultrafiltrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2022to 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults
- Veins easy to see in one or both arms
- Willing to comply with study procedures, including
- Maintaining a consistent diet and lifestyle routine throughout the study;
- Consistent habit of bland breakfast on days of clinic visits
- Abstaining from exercising on 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;
- Abstaining from music, candy, gum, computer/cell phone use, during clinic visits
Who cannot join
- Previous major gastrointestinal surgery
- Taking anti-inflammatory medications on a daily basis
- Currently experiencing intense stressful events/life changes
- Currently in intensive athletic training (such as marathon runner)
- Currently taking antipsychotic medications such as clozapine, Risperdal, Abilify, Zyprexa or Seroquel
- An unusual sleep routine
Show all 10Show fewer
- 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 sensitivities related to ingredients in active test product placebo Prescription medication evaluated on a cas-by-case basis
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
NIS Labs
Klamath Falls, Oregon, 97601
Alex Cruickshank, 541-884-0112, alex@nislabs.com
Gitte Jensen, 5418840112, gitte@nislabs.com
About this study
Official title: Clinical Poof-of-concept Study on Rapid Immune Modulating Effects
Clinical-proof-of concept study, comparing the acute immune impacts of of 2 doses of a novel blend of supplements to a placebo. This study involves twenty-four participants, composed of healthy adults, who will be taking a placebo and 2 different doses of the blend at different times. Testing for immune status and cytokine levels will be conducted to determine the acute impact of the blend on immune function as compared to the placebo.
Read the detailed description
Clinical-proof-of-concept study comparing the acute immune effects of 2 doses of a nutraceutical blend, and a placebo. The nutraceutical blend is based on a transfer factor isolated from cow colostrum ultrafiltrate.
24 subjects will participate in a placebo-controlled, randomized, double-blinded, cross-over study design, wherein they will be taking placebo, dose 1, and dose 2, each separated by a 1-week washout period.
Blood samples are taken 1 hour after participants arrive; the dose is then administered. Samples are taken 1 hour, 2 hours, and 24 hours following administration. At each blood sample collection, 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.
- Conditions
- Immune Surveillance
- Being tested
- Transfer factor from colostrum ultrafiltrate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transfer factor from colostrum ultrafiltrateDietary supplement
Proteins that confer immune protection, isolated from cow colostrum ultrafiltrate and used to promote immune health and surveillance.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Crossover study: Participants will be consuming placebo on a clinic day at least 1 week prior to a clinic day where he/she will consume the active intervention. Receives: Dietary Supplement: Transfer factor from colostrum ultrafiltrate |
| Group B | Experimental | Crossover study: Participants will be consuming the active intervention on a clinic day at least 1 week prior to a clinic day where he/she will consume placebo. Receives: Dietary Supplement: Transfer factor from colostrum ultrafiltrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune communication
Observation of changes in serum cytokine levels
Measured: 2 hours
Secondary outcomes (1)
Immune Surveillance and Alertness
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2022
- Study start7 May 2022
- Primary completionDec 2022 (estimated)
- Study completionJun 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
- Randomised
- Intervention model
- Crossover
- Model description
- Placebo-controlled, double-blinded, cross-over study design.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- 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
- NCT05364710
- Sponsor's protocol ID
- 058-006
- Status last verified
- May 2022
- First submitted
- 3 May 2022
- Last updated
- 13 May 2022
- 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 13 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Poof-of-concept Study on Rapid Immune Modulating Effects
- ClinicalTrials.gov ID
- NCT05364710
- Acronym / sponsor ID
- 058-006
- 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
- 7 May 2022 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 6 May 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 immune impacts of of 2 doses of a novel blend of supplements to a placebo. This study involves twenty-four participants, composed of healthy adults, who will be taking a placebo and 2 different doses of the blend at different times. Testing for immune status and cytokine levels will be conducted to determine the acute impact of the blend on immune function as compared to the placebo.
Detailed description
Clinical-proof-of-concept study comparing the acute immune effects of 2 doses of a nutraceutical blend, and a placebo. The nutraceutical blend is based on a transfer factor isolated from cow colostrum ultrafiltrate.
24 subjects will participate in a placebo-controlled, randomized, double-blinded, cross-over study design, wherein they will be taking placebo, dose 1, and dose 2, each separated by a 1-week washout period.
Blood samples are taken 1 hour after participants arrive; the dose is then administered. Samples are taken 1 hour, 2 hours, and 24 hours following administration. At each blood sample collection, 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Placebo-controlled, double-blinded, cross-over study design.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Dietary Supplement: Transfer factor from colostrum ultrafiltrateCrossover study: Participants will be consuming placebo on a clinic day at least 1 week prior to a clinic day where he/she will consume the active intervention. |
| Group B | Experimental | Dietary Supplement: Transfer factor from colostrum ultrafiltrateCrossover study: Participants will be consuming the active intervention on a clinic day at least 1 week prior to a clinic day where he/she will consume placebo. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Healthy adults
- Veins easy to see in one or both arms
- Willing to comply with study procedures, including
- Maintaining a consistent diet and lifestyle routine throughout the study;
- Consistent habit of bland breakfast on days of clinic visits
Key exclusion criteria (10 listed)
- Previous major gastrointestinal surgery
- Taking anti-inflammatory medications on a daily basis
- Currently experiencing intense stressful events/life changes
- Currently in intensive athletic training (such as marathon runner)
- Currently taking antipsychotic medications such as clozapine, Risperdal, Abilify, Zyprexa or Seroquel
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 |
|---|---|---|
| Transfer factor from colostrum ultrafiltrateProteins that confer immune protection, isolated from cow colostrum ultrafiltrate and used to promote immune health and surveillance. | Dietary supplement | Group A, Group B |
Primary outcome
Immune communication
Time frame: 2 hours
Observation of changes in serum cytokine levels
1 secondary outcome
Immune Surveillance and Alertness
Time frame: 2 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2022.
- 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 Transfer factor from colostrum ultrafiltrate 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 8 inclusion and 10 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 13 May 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. 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 communication (time frame: 2 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 13 May 2022.