Stem Cell MobilizationNCT03388073
Evaluation of Plant-based Nutritional Products on Stem Cells
A study testing Berry extract I, Berry Extract II and Berry extract blend in people with Stem Cell Mobilization and Hematopoietic Stem Cell Mobilization, run by Natural Immune Systems Inc at 1 site in United States.
Trial summary
The purpose of this clinical study is to evaluate acute effects of plant-based nutritional extracts on adult stem cells, using a randomized double-blinded placebo-controlled cross-over study design. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Stem Cell Mobilization, Hematopoietic Stem Cell Mobilization, Stem Cell Homing
- What is being tested?
- Berry extract I, Berry Extract II and Berry extract blend
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2018to 2 Feb 2020
- 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 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults 20-75 years of age;
- Body weight higher than 110 pounds;
- BMI below 35;
Who cannot join
- Previous major gastrointestinal surgery (absorption of test product may be altered) (minor surgery not a problem);
- Currently taking daily OTC medications, such as NSAIDs, Tylenol, allergy medications, and others (birth control and 81 mg aspirin not a problem);
- Taking medications that affect the mind (such as anti-depressants) or nervous system (such as gabapentin);
- Currently experiencing intense stressful events and life changes;
- Actively depressed;
- Experiencing sleep disturbances;
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- Working night shift;
- Pregnant, nursing, or trying to become pregnant;
- Food intolerances or allergies currently causing discomfort (such as Celiac's disease), due to ongoing inflammatory reactions that may negatively affect product absorption within the 3 hours of testing;
- Food allergies related to ingredients in test product.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Natural Immune Systems
Klamath Falls, Oregon, 97601
Gitte Jensen, 541-884-0112, gitte@nislabs.com
About this study
The purpose of this clinical study is to evaluate acute effects of plant-based nutritional extracts on adult stem cells, using a randomized double-blinded placebo-controlled cross-over study design.
Read the detailed description
The purpose of this clinical study is to evaluate acute effects of plant-based nutritional extracts on adult stem cells, using a randomized double-blinded placebo-controlled cross-over study design. The research involves testing of acute effects of single doses of antioxidant-rich berry-based extracts, compared to a placebo. Blood samples are taken at baseline and 1 and 2 hours after consuming a single dose. The blood will be used to measure the numbers of different types of stem cells, to evaluate potential effects of stem cell mobilization and homing after consuming plant-based extracts. Adult stem cells are a type of cells that play a role in repairing and rejuvenating various tissue and organs in the body. At NIS Labs, we have shown that many types of plant-based nutritional products have small but reproducible and significant effects on stem cells, cytokines, and regenerative growth factors.
- Being tested
- Berry extract I, Berry Extract II, Berry extract blend, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Berry extract IOther
Seabuckthorn berry proanthocyanidin extract 250 mg single dose
Berry Extract IIOther
Seabuckthorn berry proanthocyanidin extract 500 mg single dose
Berry extract blendOther
Seabuckthorn berry blend with other berry-based antioxidants
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Berry extract I | Experimental | Plant-based antioxidant-rich berry-based extract. Receives: Other: Berry extract I |
| Berry extract II | Experimental | Plant-based antioxidant-rich berry-based extract. Receives: Other: Berry Extract II |
| Berry extract blend | Experimental | Blend of plant-based antioxidant-rich berry-based extracts. Receives: Other: Berry extract blend |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change to stem cell numbers in blood circulation.
Flow cytometry evaluation of stem cell phenotype.
Measured: Changes at 1 and 2 hours after consumption.
Secondary outcomes (5)
Change to numbers of circulating CD45dim CD34+ stem cells in blood circulation.
Flow cytometry evaluation of stem cell phenotype.
Measured: Changes at 1 and 2 hours after consumption.
Change to numbers of circulating CD45dim CD34+ CD309- stem cells in blood circulation.
Flow cytometry evaluation of stem cell phenotype.
Measured: Changes at 1 and 2 hours after consumption.
Change to numbers of circulating CD45dim CD34+ CD309+ stem cells in blood circulation.
Flow cytometry evaluation of stem cell phenotype.
Measured: Changes at 1 and 2 hours after consumption.
Change to numbers of circulating CD45- CD31+ CD309+ stem cells in blood circulation.
Flow cytometry evaluation of stem cell phenotype.
Measured: Changes at 1 and 2 hours after consumption.
Change to numbers of circulating CD45- CD90+ stem cells in blood circulation.
Flow cytometry evaluation of stem cell phenotype.
Measured: Changes at 1 and 2 hours after consumption.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2018
- Study start30 Jan 2018
- Primary completion20 Dec 2019 (estimated)
- Study completion2 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stem Cell MobilizationStudies 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
- The study uses a randomized double-blinded placebo-controlled cross-over study design.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Natural Immune Systems Inc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gitte Jensen, Study director, NIS Labs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03388073
- Sponsor's protocol ID
- NIS135002
- Status last verified
- Feb 2019
- First submitted
- 23 Dec 2017
- Last updated
- 13 Mar 2019
- Results posted
- 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 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Plant-based Nutritional Products on Stem Cells
- ClinicalTrials.gov ID
- NCT03388073
- Acronym / sponsor ID
- NIS135002
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Natural Immune Systems IncUniversity, hospital or other
- Study start
- 30 Jan 2018 (actual)
- Primary completion
- 20 Dec 2019 (estimated)
- Study completion
- 2 Feb 2020 (estimated)
- First posted
- 2 Jan 2018 (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.
The purpose of this clinical study is to evaluate acute effects of plant-based nutritional extracts on adult stem cells, using a randomized double-blinded placebo-controlled cross-over study design.
Detailed description
The purpose of this clinical study is to evaluate acute effects of plant-based nutritional extracts on adult stem cells, using a randomized double-blinded placebo-controlled cross-over study design. The research involves testing of acute effects of single doses of antioxidant-rich berry-based extracts, compared to a placebo. Blood samples are taken at baseline and 1 and 2 hours after consuming a single dose. The blood will be used to measure the numbers of different types of stem cells, to evaluate potential effects of stem cell mobilization and homing after consuming plant-based extracts. Adult stem cells are a type of cells that play a role in repairing and rejuvenating various tissue and organs in the body. At NIS Labs, we have shown that many types of plant-based nutritional products have small but reproducible and significant effects on stem cells, cytokines, and regenerative growth factors.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
- Model description
- The study uses a randomized double-blinded placebo-controlled cross-over study design.
| Arm | Type | Receives |
|---|---|---|
| Berry extract I | Experimental | Other: Berry extract IPlant-based antioxidant-rich berry-based extract. |
| Berry extract II | Experimental | Other: Berry Extract IIPlant-based antioxidant-rich berry-based extract. |
| Berry extract blend | Experimental | Other: Berry extract blendBlend of plant-based antioxidant-rich berry-based extracts. |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy adults 20-75 years of age;
- Body weight higher than 110 pounds;
- BMI below 35;
Key exclusion criteria (10 listed)
- Previous major gastrointestinal surgery (absorption of test product may be altered) (minor surgery not a problem);
- Currently taking daily OTC medications, such as NSAIDs, Tylenol, allergy medications, and others (birth control and 81 mg aspirin not a problem);
- Taking medications that affect the mind (such as anti-depressants) or nervous system (such as gabapentin);
- Currently experiencing intense stressful events and life changes;
- Actively depressed;
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 |
|---|---|---|
| Berry extract ISeabuckthorn berry proanthocyanidin extract 250 mg single dose | Other | Berry extract I |
| Berry Extract IISeabuckthorn berry proanthocyanidin extract 500 mg single dose | Other | Berry extract II |
| Berry extract blendSeabuckthorn berry blend with other berry-based antioxidants | Other | Berry extract blend |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Change to stem cell numbers in blood circulation.
Time frame: Changes at 1 and 2 hours after consumption.
Flow cytometry evaluation of stem cell phenotype.
5 secondary outcomes
Change to numbers of circulating CD45dim CD34+ stem cells in blood circulation.
Time frame: Changes at 1 and 2 hours after consumption.
Change to numbers of circulating CD45dim CD34+ CD309- stem cells in blood circulation.
Time frame: Changes at 1 and 2 hours after consumption.
Change to numbers of circulating CD45dim CD34+ CD309+ stem cells in blood circulation.
Time frame: Changes at 1 and 2 hours after consumption.
Change to numbers of circulating CD45- CD31+ CD309+ stem cells in blood circulation.
Time frame: Changes at 1 and 2 hours after consumption.
Change to numbers of circulating CD45- CD90+ stem cells in blood circulation.
Time frame: Changes at 1 and 2 hours after consumption.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
- 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.
Gitte Jensen study director
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 Berry extract I, Berry Extract II and Berry extract blend in people with Stem Cell Mobilization and Hematopoietic Stem Cell Mobilization, 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 3 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 Mar 2019. 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 (5418840112, gitte@nislabs.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change to stem cell numbers in blood circulation. (time frame: Changes at 1 and 2 hours after consumption.). 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 Mar 2019.