HypertriglyceridemiasNCT00938249
Effects of Monascus Garlic Fermented Extract on Serum Triglyceride Level
A study testing Monascus Garlic Fermented Extract in people with Hypertriglyceridemias, run by Hiroshima University at 1 site in Japan.
Trial summary
The purpose of the study is to determine the effect of monascus garlic fermented extract on serum lipid concentrations in subjects with moderately elevated serum triglyceride. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertriglyceridemias
- What is being tested?
- Monascus Garlic Fermented Extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteJapan
- Study dates
- Jul 2009to Feb 2010
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy as based on medical history and physical examination
- Fasting serum triglyceride 120 to 200mg/dl
- Willing not to serve as blood donor during the study
- Informed consent signed
Who cannot join
- Female subjects who are pregnant or nursing a child
- Participation in any clinical trial up to 90 days before Day 1 of this study
- Renal or hepatic dysfunction
- Heart disease
- Under medication
- Subjects who are taking functional food designed for weight loss or serum lipid reduction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Monascus Garlic Fermented Extract on Serum Triglyceride Level: a Double-Blind, Randomized Controlled Trial
The purpose of the study is to determine the effect of monascus garlic fermented extract on serum lipid concentrations in subjects with moderately elevated serum triglyceride.
- Conditions
- Hypertriglyceridemias
- Being tested
- Monascus Garlic Fermented Extract, Placebo
- Keywords
- Moderately Elevated Serum Triglyceride
- Medical subject headings
- Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monascus Garlic Fermented ExtractDietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Monascus Garlic Fermented Extract | Experimental | Not described Receives: Dietary Supplement: Monascus Garlic Fermented Extract |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting triglyceride level
Measured: Every 4 weeks (Overall 20 weeks)
Secondary outcomes (4)
Abdominal circumference
Measured: Every 4 weeks (Overall 20 weeks)
Visceral fat area by CT scan
Measured: Week 0 and Week 12
Serum total cholesterol and LDL cholesterol levels
Measured: Every 4 weeks (Overall 20 weeks)
Serum adiponectin level
Measured: Week 0 and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertriglyceridemiasStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hiroshima University
- Sponsor type
- University, hospital or other
- Collaborators
- Wakunaga Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00938249
- Sponsor's protocol ID
- eki-146
- Status last verified
- Apr 2010
- First submitted
- 10 Jul 2009
- Last updated
- 26 Apr 2010
- Results posted
- No
Publications
Higashikawa F, Noda M, Awaya T, Ushijima M, Sugiyama M. Reduction of serum lipids by the intake of the extract of garlic fermented with Monascus pilosus: a randomized, double-blind, placebo-controlled clinical trial. Clin Nutr. 2012 Apr;31(2):261-6. doi: 10.1016/j.clnu.2011.10.008. Epub 2011 Oct 29.
PubMed 22041543
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Monascus Garlic Fermented Extract on Serum Triglyceride Level: a Double-Blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00938249
- Acronym / sponsor ID
- eki-146
- Conditions
- Hypertriglyceridemias
- Keywords
- Moderately Elevated Serum Triglyceride
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Hiroshima UniversityUniversity, hospital or other
- Collaborators
- Wakunaga Pharmaceutical Co., Ltd.
- Study start
- Jul 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 13 Jul 2009 (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 purpose of the study is to determine the effect of monascus garlic fermented extract on serum lipid concentrations in subjects with moderately elevated serum triglyceride.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monascus Garlic Fermented Extract | Experimental | Dietary Supplement: Monascus Garlic Fermented Extract |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy as based on medical history and physical examination
- Fasting serum triglyceride 120 to 200mg/dl
- Willing not to serve as blood donor during the study
- Informed consent signed
Key exclusion criteria (6 listed)
- Female subjects who are pregnant or nursing a child
- Participation in any clinical trial up to 90 days before Day 1 of this study
- Renal or hepatic dysfunction
- Heart disease
- Under medication
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 |
|---|---|---|
| Monascus Garlic Fermented Extract | Dietary supplement | Monascus Garlic Fermented Extract |
| Placebo | Dietary supplement | Placebo |
Primary outcome
Fasting triglyceride level
Time frame: Every 4 weeks (Overall 20 weeks)
4 secondary outcomes
Abdominal circumference
Time frame: Every 4 weeks (Overall 20 weeks)
Visceral fat area by CT scan
Time frame: Week 0 and Week 12
Serum total cholesterol and LDL cholesterol levels
Time frame: Every 4 weeks (Overall 20 weeks)
Serum adiponectin level
Time frame: Week 0 and Week 12
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 26 Apr 2010.
- Derived from this study: PubMed 22041543Higashikawa F, Noda M, Awaya T, Ushijima M, Sugiyama M. Reduction of serum lipids by the intake of the extract of garlic fermented with Monascus pilosus: a randomized, double-blind, placebo-controlled clinical trial. Clin Nutr. 2012 Apr;31(2):261-6. doi: 10.1016/j.clnu.2011.10.008. Epub 2011 Oct 29.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monascus Garlic Fermented Extract in people with Hypertriglyceridemias, run by Hiroshima University at 1 site in Japan.
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 4 inclusion and 6 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 26 Apr 2010. 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 Japan. 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?
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?
Fasting triglyceride level (time frame: Every 4 weeks (Overall 20 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00938249, which also lists 1 linked publication.
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 26 Apr 2010.