HypercholesterolemiaPhase 4NCT02913170
Nattokinase Supplementation and Hemostatic Factors
A Phase 4 study testing Nattokinase in people with Hypercholesterolemia, run by Yonsei University at 1 site in South Korea.
Trial summary
The aim of this study is to examine the effects of nattokinase supplementation on hemostatic factors in nondiabetic and hypercholesterolemic subjects. Collagen-epinephrine closure time, prothrombin time, activated partial thromboplastin time, fibrinogen levels, and lipid profiles were measured at baseline and at… Read more about this study
- Who is it for?
- Ages 20 to 69 years
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Nattokinase
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2015to Sep 2016
- 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 20 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 20 and 69 years
- Hypercholesterolemia (200mg/dL ≤ serum cholesterol ≤ 280mg/dL)
- Nondiabetic (fasting blood glucose < 126mg/dL and 2-hour blood glucose < 200mg/dL)
Who cannot join
- Use of any medication or supplements
- Diagnosis of dyslipidemia, diabetes mellitus, hypertension, liver disease, renal disease, cardiovascular disease, pancreatitis, cancer, or any life-threatening illness that required regular medical treatment
- Women who were pregnant, breastfeeding or intending to become pregnant during the study period
- Drug or alcohol abuse
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University.
Seoul, 120-749
About this study
The aim of this study is to examine the effects of nattokinase supplementation on hemostatic factors in nondiabetic and hypercholesterolemic subjects. Collagen-epinephrine closure time, prothrombin time, activated partial thromboplastin time, fibrinogen levels, and lipid profiles were measured at baseline and at 8-week follow-up.
- Conditions
- Hypercholesterolemia
- Being tested
- Nattokinase, Placebo
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NattokinaseDietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Nattokinase group | Experimental | A nattokinase group composed of 50 individuals who consumed a 300mg nattokinase capsule (100mg of nattokinase and 200mg of maltodextrin) daily after meal. Receives: Dietary Supplement: Nattokinase |
| Placebo group | Placebo comparator | A placebo group composed of 50 individuals who consumed a 300mg placebo capsule (300mg of maltodextrin) daily after meal. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collagen-epinephrine closure time at baseline
Measured: baseline
Collagen-epinephrine closure time at 8-week follow-up
Measured: 8-week follow-up
Secondary outcomes (6)
Prothrombin time at baseline
Measured: baseline
Prothrombin time at 8-week follow-up
second
Measured: 8-week follow-up
Activated partial thromboplastin time at baseline
Measured: baseline
Activated partial thromboplastin time at 8-week follow-up
Measured: 8-week follow-up
Fibrinogen concentration at baseline
mg/dL
Measured: baseline
Fibrinogen concentration at 8-week follow-up
mg/dL
Measured: 8-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2016 (estimated)
- Study startMay 2015
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong Ho Lee, Yonsei University
- Investigators
- Jong Ho Lee, Ph.D., Principal investigator, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02913170
- Sponsor's protocol ID
- NP_intervention
- Status last verified
- Sep 2016
- First submitted
- 20 Sep 2016
- Last updated
- 23 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nattokinase Supplementation and Hemostatic Factors
- ClinicalTrials.gov ID
- NCT02913170
- Acronym / sponsor ID
- NP_intervention
- Conditions
- Hypercholesterolemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 23 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.
The aim of this study is to examine the effects of nattokinase supplementation on hemostatic factors in nondiabetic and hypercholesterolemic subjects. Collagen-epinephrine closure time, prothrombin time, activated partial thromboplastin time, fibrinogen levels, and lipid profiles were measured at baseline and at 8-week follow-up.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nattokinase group | Experimental | Dietary Supplement: NattokinaseA nattokinase group composed of 50 individuals who consumed a 300mg nattokinase capsule (100mg of nattokinase and 200mg of maltodextrin) daily after meal. |
| Placebo group | Placebo comparator | Dietary Supplement: PlaceboA placebo group composed of 50 individuals who consumed a 300mg placebo capsule (300mg of maltodextrin) daily after meal. |
Who may qualify
- Ages
- 20 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 20 and 69 years
- Hypercholesterolemia (200mg/dL ≤ serum cholesterol ≤ 280mg/dL)
- Nondiabetic (fasting blood glucose < 126mg/dL and 2-hour blood glucose < 200mg/dL)
Key exclusion criteria (4 listed)
- Use of any medication or supplements
- Diagnosis of dyslipidemia, diabetes mellitus, hypertension, liver disease, renal disease, cardiovascular disease, pancreatitis, cancer, or any life-threatening illness that required regular medical treatment
- Women who were pregnant, breastfeeding or intending to become pregnant during the study period
- Drug or alcohol abuse
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 |
|---|---|---|
| Nattokinase | Dietary supplement | Nattokinase group |
| Placebo | Dietary supplement | Placebo group |
Primary outcome
Collagen-epinephrine closure time at baseline
Time frame: baseline
Collagen-epinephrine closure time at 8-week follow-up
Time frame: 8-week follow-up
6 secondary outcomes
Prothrombin time at baseline
Time frame: baseline
Prothrombin time at 8-week follow-up
Time frame: 8-week follow-up
Activated partial thromboplastin time at baseline
Time frame: baseline
Activated partial thromboplastin time at 8-week follow-up
Time frame: 8-week follow-up
Fibrinogen concentration at baseline
Time frame: baseline
Fibrinogen concentration at 8-week follow-up
Time frame: 8-week follow-up
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 23 Sep 2016.
- Individual participant dataSharing planned: No
Related trials for Hypercholesterolemia
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Primary Prevention of Atherosclerotic Cardiovascular Disease
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Effectiveness and Tolerability of a Treat-to-Target Versus Fixed-Dose Statin Strategy in Patients With Atherosclerotic Cardiovascular Disease
Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia, Stroke (CVA) or TIA
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
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Active, not recruitingObservational study
Evaluation of the Effect of Lomitapide Treatment on Major Adverse Cardiovascular Events (MACE) in Patients With Homozygous Familial Hypercholesterolemia
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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.
Jong Ho Lee, Ph.D. principal investigator
Yonsei University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nattokinase in people with Hypercholesterolemia, run by Yonsei University at 1 site in South Korea.
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 4 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 23 Sep 2016. 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 South Korea. 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.
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?
Collagen-epinephrine closure time at baseline (time frame: baseline). The study lists 2 primary outcomes in all. 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 23 Sep 2016; AzTrials last refreshed its copy on 6 Nov 2026.