HypertensionPhase 4NCT02886507
Effects of NSK-SD (Nattokinase) on Blood Pressure
A Phase 4 study testing NSK-SD (nattokinase) in people with Hypertension, run by Natural Immune Systems Inc.
Trial summary
This is a randomized double-blinded placebo-controlled study to evaluate the effects of NSK-SD consumption in subjects with Stage I hypertension. The study population will be randomized into two groups, where both groups will receive dietary and lifestyle recommendations to help reduce hypertension. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- NSK-SD (nattokinase)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- No sites listed yet
- Study dates
- Mar 2012to Jun 2014
- Phase
- Phase 4
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults of both genders;
- Age 18-85 years;
- Elevated blood pressure as identified by:
- Systolic blood pressure 130mmHg or higher, or diastolic blood pressure 90mmHg or higher;
- Confirmed on three separate occasions.
Who cannot join
- Use of Nattokinase-containing supplements within 60 days prior to enrollment;
- Currently on blood pressure medication;
- History of cancer chemotherapy within the last 12 months;
- Significant active uncontrolled disease (such as lymphoma, cirrhosis, nephritis, uncompensated heart failure);
- Consumption of more than an average of 2 standard alcoholic drinks/day (14 drinks per week)
- Currently experiencing intense stressful events/ life changes that would negatively affect compliance;
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- Pregnant, nursing, or trying to become pregnant;
- Women not using effective contraception;
- Food allergies related to ingredients in test product.
About this study
Official title: Effects of NSK-SD (Nattokinase) on Blood Pressure. A Randomized, Double-blind, Placebo-controlled Clinical Trial
This is a randomized double-blinded placebo-controlled study to evaluate the effects of NSK-SD consumption in subjects with Stage I hypertension.
The study population will be randomized into two groups, where both groups will receive dietary and lifestyle recommendations to help reduce hypertension. One group will receive placebo and the other group NSK-SD for 8 weeks.
The endpoint will be the change in systolic and diastolic blood pressure after 8 weeks of treatment in the two subject groups.
Read the detailed description
Previous randomized double blinded placebo-controlled studies on the consumption of the fibrinolytic enzyme Nattokinase and NSK-SD is transported across the gut, and has shown multiple effects on vascular health, including fibrinolytic effects and regulation of blood pressure.
A previous study on effects on blood pressure was conducted in an Asian population involving 86 people, where 73 people completed the study requirements (39 in the NSK-SD group, 34 in the placebo group). The data showed statistically significant reduction in both systolic and diastolic blood pressure after consumption of Nattokinase, whereas the changes after consuming placebo were not significantly different from baseline.
The objective of this study is to evaluate the effects of consumption of nattokinase on hypertension in a North American hypertensive population with associated genetic, dietary, and lifestyle factors. This is in extension of, and contrast to, previous studies in Asian populations.
- Conditions
- Hypertension
- Being tested
- NSK-SD (nattokinase), Placebo
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NSK-SD (nattokinase)Dietary supplement
Nattokinase is a fibrinolytic enzyme from the fermented soy product natto. Encapsulated 100mg/capsule, excipient include microcrystalline cellulose.
PlaceboDietary supplement
The placebo capsules contain microcrystalline cellulose.
| Study group | Role | What they receive |
|---|---|---|
| NSK-SD (nattokinase) | Active comparator | One capsule (100 mg) nattokinase/day for the 8-week study duration. Receives: Dietary Supplement: NSK-SD (nattokinase) |
| Placebo | Placebo comparator | One capsule placebo/day for the 8-week study duration. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of hypertension
Measured: Eight weeks
Secondary outcomes (2)
von Willebrand factor
Measured: Eight weeks
Plasma renin activity
Measured: Eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2016 (estimated)
- Study startMar 2012
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Natural Immune Systems Inc
- Sponsor type
- University, hospital or other
- Collaborators
- JBSL-USA Incorporated
- Responsible party
- Principal investigator, Gitte Jensen, Ph.D., Natural Immune Systems Inc
- Investigators
- Gitte S Jensen, PhD, Principal investigator, NIS Labs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02886507
- Sponsor's protocol ID
- NIS 087-001
- Status last verified
- Aug 2016
- First submitted
- 29 Aug 2016
- Last updated
- 1 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Manuscript publication.
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of NSK-SD (Nattokinase) on Blood Pressure. A Randomized, Double-blind, Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02886507
- Acronym / sponsor ID
- NIS 087-001
- Conditions
- Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Natural Immune Systems IncUniversity, hospital or other
- Collaborators
- JBSL-USA Incorporated
- Study start
- Mar 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 1 Sep 2016 (estimated)
- 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.
This is a randomized double-blinded placebo-controlled study to evaluate the effects of NSK-SD consumption in subjects with Stage I hypertension.
The study population will be randomized into two groups, where both groups will receive dietary and lifestyle recommendations to help reduce hypertension. One group will receive placebo and the other group NSK-SD for 8 weeks.
The endpoint will be the change in systolic and diastolic blood pressure after 8 weeks of treatment in the two subject groups.
Detailed description
Previous randomized double blinded placebo-controlled studies on the consumption of the fibrinolytic enzyme Nattokinase and NSK-SD is transported across the gut, and has shown multiple effects on vascular health, including fibrinolytic effects and regulation of blood pressure.
A previous study on effects on blood pressure was conducted in an Asian population involving 86 people, where 73 people completed the study requirements (39 in the NSK-SD group, 34 in the placebo group). The data showed statistically significant reduction in both systolic and diastolic blood pressure after consumption of Nattokinase, whereas the changes after consuming placebo were not significantly different from baseline.
The objective of this study is to evaluate the effects of consumption of nattokinase on hypertension in a North American hypertensive population with associated genetic, dietary, and lifestyle factors. This is in extension of, and contrast to, previous studies in Asian populations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NSK-SD (nattokinase) | Active comparator | Dietary Supplement: NSK-SD (nattokinase)One capsule (100 mg) nattokinase/day for the 8-week study duration. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboOne capsule placebo/day for the 8-week study duration. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy adults of both genders;
- Age 18-85 years;
- Elevated blood pressure as identified by:
Key exclusion criteria (9 listed)
- Use of Nattokinase-containing supplements within 60 days prior to enrollment;
- Currently on blood pressure medication;
- History of cancer chemotherapy within the last 12 months;
- Significant active uncontrolled disease (such as lymphoma, cirrhosis, nephritis, uncompensated heart failure);
- Consumption of more than an average of 2 standard alcoholic drinks/day (14 drinks per week)
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 |
|---|---|---|
| NSK-SD (nattokinase)Nattokinase is a fibrinolytic enzyme from the fermented soy product natto. Encapsulated 100mg/capsule, excipient include microcrystalline cellulose. | Dietary supplement | NSK-SD (nattokinase) |
| PlaceboThe placebo capsules contain microcrystalline cellulose. | Dietary supplement | Placebo |
Primary outcome
Reduction of hypertension
Time frame: Eight weeks
2 secondary outcomes
von Willebrand factor
Time frame: Eight weeks
Plasma renin activity
Time frame: Eight weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2016.
- Individual participant dataSharing planned: Yes. Manuscript publication.
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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 S Jensen, PhD principal investigator
NIS Labs
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing NSK-SD (nattokinase) in people with Hypertension, run by Natural Immune Systems Inc.
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 9 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: finished, as of the sponsor's last update on 1 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of hypertension (time frame: Eight weeks). 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 1 Sep 2016.