High Blood SugarNCT05737342
Effect of ANKASCIN 568-P Products on Decreasing HbA1c and Regulating Blood Glucose
A study testing ANKASCIN 568-P Red yeast rice capsules in people with High Blood Sugar and Metabolic Syndrome, run by SunWay Biotech Co., LTD. at 1 site in Taiwan.
Trial summary
This study is a randomized, double-blind, placebo-controlled, parallel-controlled trial (24 weeks in total), divided into three periods (screening, treatment, and discontinuation follow-up) Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- High Blood Sugar, Metabolic Syndrome
- What is being tested?
- ANKASCIN 568-P Red yeast rice capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Apr 2023to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or non-pregnant women over 20 years old (women of childbearing age are not allowed to become pregnant or breastfeed during the study) adults who are sane and able to communicate.
- 18≦BMI≦35.
- Blood routine examination (CBC; Complete blood count): the mean corpuscular volume MCV should not be less than 70 fL.
- Blood glucose level measurement meets any of the following conditions:
- The fasting blood sugar is between 100∼125 mg/dL, and the doctor judges that there is no need to use hypoglycemic drugs for the time being.
- Or the glycosylated hemoglobin is between 5.7∼6.4%, and the doctor judges that the use of hypoglycemic drugs is not needed for the time being.
Show all 10Show fewer
- Diabetic patients who have no willingness to take medicine and have not taken hypoglycemic drugs in the past month.
- 5. Those without other serious diseases (cancer, heart failure, myocardial infarction, liver cirrhosis, moderate to severe liver and kidney dysfunction, stroke, etc.).
- 6. Hypoglycemic drugs are not allowed to be used during the trial. If the condition changes and the use of hypoglycemic drugs is required, the trial must be withdrawn.
- 7. During the test period, the daily routine and eating habits should be maintained without deliberately changing them.
Who cannot join
- Blood pressure: systolic blood pressure ≧ 200 mmHg or diastolic blood pressure ≧ 140 mmHg.
- Moderate or severe liver and kidney dysfunction (generally refers to serum aminopyruvate converting enzyme (SGPT) and serum glutamate phenylacetate transaminase (SGOT) are more than 3 times higher than the upper limit of normal value or have been diagnosed Liver cirrhosis, or glomerular filtration rate eGFR≦30 ml/min/1.73m2).
- Pregnant or lactating women.
- Diabetic patients taking hypoglycemic drugs or insulin injections.
- Those who take traditional Chinese medicine mainly red yeast rice.
- Have undergone surgery within one month.
- Combined with serious diseases such as heart, liver, kidney and hematopoietic system, mentally ill patients who do not meet the inclusion criteria, who do not eat the test samples according to the regulations, so that the efficacy cannot be judged or the incomplete data affect the judgment of efficacy or safety.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Tri-Service General Hospital, National Defense Medical Center, Taipei city,
Taipei, 114202
WEN-HUI FANG, PhD, rumaf.fang@gmail.com
About this study
Official title: Effect of ANKASCIN 568-P Products on Decreasing HbA1c and Regulating Blood Glucose- A Double-blind, Placebo-controlled Clinical Research
This study is a randomized, double-blind, placebo-controlled, parallel-controlled trial (24 weeks in total), divided into three periods (screening, treatment, and discontinuation follow-up)
Read the detailed description
This trial is a randomized double-blind human trial, mainly to investigate the effect of long-term consumption of red yeast rice products on reducing glycated hemoglobin (HbA1c) and regulating blood sugar. It is expected to recruit 80 subjects for a period of 24 weeks. The test group takes 2 capsules of red yeast rice per day (Each capsule contains 440mg ANKASCIN 568-P), the control group took placebo capsules daily, blood samples were collected for biochemical analysis at 0, 4, 12, and 24 weeks, and the general body position measurement, blood pressure, Blood lipids, blood sugar and other related changes, and monitor liver, kidney, thyroid function.
- Conditions
- High Blood Sugar, Metabolic Syndrome
- Being tested
- ANKASCIN 568-P Red yeast rice capsules, Placebo Capsules
- Medical subject headings
- Hyperglycemia, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANKASCIN 568-P Red yeast rice capsulesDietary supplement
Product ingredients: ANKASCIN 568-P red yeast rice product 440 mg,microcrystalline ,cellulose,Maltodextrin; capsule shell composition: HPMC (hydroxypropyl methylcellulose), purified water, titanium dioxide, gellan gum.
Placebo CapsulesDietary supplement
Maltodextrin was used as a placebo
| Study group | Role | What they receive |
|---|---|---|
| ANKASCIN 568-P Red yeast rice capsules | Experimental | ANKASCIN 568-P is a fermented product from the red yeast rice fungus <Monascus purpureus NTU 568>. It does not contain Monacolin K, an ingredient that may harm the human body, and is rich in new active ingredients. Take 2 red yeast rice capsules (each containing 440mg ANKASCIN 568-P) every day, and the control group takes 2 placebo capsules (containing equal weight maltodextrin) every day, respectively, at the 0th, 4th , , 12, 24, Collect blood samples for biochemical analysis and record the general body position measurement, blood pressure, blood lipid, blood sugar and other related changes of the subjects, and monitor the liver, kidney, and thyroid functions. Receives: Dietary Supplement: ANKASCIN 568-P Red yeast rice capsules |
| Placebo Capsules | Placebo comparator | Maltodextrin was used as a placebo. Receives: Dietary Supplement: Placebo Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improve glycated hemoglobin (HbA1c) value
After 24 weeks of taking red yeast rice capsules or placebo gel, whether there is a statistical difference between the test group and the placebo group in terms of improving the HbA1c value of glycosylated hemoglobin.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start1 Apr 2023
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for High Blood SugarStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SunWay Biotech Co., LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- WEN-HUI FANG, Ph. D., Principal investigator, Chief of Family medicine department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05737342
- Sponsor's protocol ID
- 22 ANKASCIN 568-P
- Status last verified
- Aug 2025
- First submitted
- 10 Feb 2023
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hsu LC, Hsu YW, Hong CC, Pan TM. Safety and mutagenicity evaluation of red mold dioscorea fermented from Monascus purpureus NTU 568. Food Chem Toxicol. 2014 May;67:161-8. doi: 10.1016/j.fct.2014.02.033. Epub 2014 Feb 28.
PubMed 24582683Shi YC, Pan TM. Anti-diabetic effects of Monascus purpureus NTU 568 fermented products on streptozotocin-induced diabetic rats. J Agric Food Chem. 2010 Jul 14;58(13):7634-40. doi: 10.1021/jf101194f.
PubMed 20557124Shi YC, Pan TM. Antioxidant and pancreas-protective effect of red mold fermented products on streptozotocin-induced diabetic rats. J Sci Food Agric. 2010 Nov;90(14):2519-25. doi: 10.1002/jsfa.4115.
PubMed 20737515Shi YC, Liao JW, Pan TM. Antihypertriglyceridemia and anti-inflammatory activities of monascus-fermented dioscorea in streptozotocin-induced diabetic rats. Exp Diabetes Res. 2011;2011:710635. doi: 10.1155/2011/710635. Epub 2011 May 11.
PubMed 21716679Lee BH, Hsu WH, Huang T, Chang YY, Hsu YW, Pan TM. Monascin improves diabetes and dyslipidemia by regulating PPARgamma and inhibiting lipogenesis in fructose-rich diet-induced C57BL/6 mice. Food Funct. 2013 Jun;4(6):950-9. doi: 10.1039/c3fo60062a. Epub 2013 May 14.
PubMed 23673903Chen CL, Pan TM. Effects of red mold dioscorea with pioglitazone, a potentially functional food, in the treatment of diabetes. J Food Drug Anal. 2015 Dec;23(4):719-728. doi: 10.1016/j.jfda.2015.04.013. Epub 2015 Jul 21.
PubMed 28911488Slim R, Ben Salem C, Zamy M, Biour M. Pioglitazone-induced acute rhabdomyolysis. Diabetes Care. 2009 Jul;32(7):e84. doi: 10.2337/dc09-0593. No abstract available.
PubMed 19564463Wang YR, Liu SF, Shen YC, Chen CL, Huang CN, Pan TM, Wang CK. A randomized, double-blind clinical study to determine the effect of ANKASCIN 568 plus on blood glucose regulation. J Food Drug Anal. 2017 Apr;25(2):409-416. doi: 10.1016/j.jfda.2016.06.011. Epub 2016 Jul 30.
PubMed 28911684Liu SF, Wang YR, Shen YC, Chen CL, Huang CN, Pan TM, Wang CK. A randomized, double-blind clinical study of the effects of Ankascin 568 plus on blood lipid regulation. J Food Drug Anal. 2018 Jan;26(1):393-400. doi: 10.1016/j.jfda.2017.04.006. Epub 2017 Jun 1.
PubMed 29389579
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of ANKASCIN 568-P Products on Decreasing HbA1c and Regulating Blood Glucose- A Double-blind, Placebo-controlled Clinical Research
- ClinicalTrials.gov ID
- NCT05737342
- Acronym / sponsor ID
- 22 ANKASCIN 568-P
- Conditions
- High Blood Sugar, Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- SunWay Biotech Co., LTD.Industry (pharma, biotech, devices)
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 21 Feb 2023 (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.
This study is a randomized, double-blind, placebo-controlled, parallel-controlled trial (24 weeks in total), divided into three periods (screening, treatment, and discontinuation follow-up)
Detailed description
This trial is a randomized double-blind human trial, mainly to investigate the effect of long-term consumption of red yeast rice products on reducing glycated hemoglobin (HbA1c) and regulating blood sugar. It is expected to recruit 80 subjects for a period of 24 weeks. The test group takes 2 capsules of red yeast rice per day (Each capsule contains 440mg ANKASCIN 568-P), the control group took placebo capsules daily, blood samples were collected for biochemical analysis at 0, 4, 12, and 24 weeks, and the general body position measurement, blood pressure, Blood lipids, blood sugar and other related changes, and monitor liver, kidney, thyroid function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ANKASCIN 568-P Red yeast rice capsules | Experimental | Dietary Supplement: ANKASCIN 568-P Red yeast rice capsulesANKASCIN 568-P is a fermented product from the red yeast rice fungus <Monascus purpureus NTU 568>. It does not contain Monacolin K, an ingredient that may harm the human body, and is rich in new active ingredients. Take 2 red yeast rice capsules (each containing 440mg ANKASCIN 568-P) every day, and the control group takes 2 placebo capsules (containing equal weight maltodextrin) every day, respectively, at the 0th, 4th , , 12, 24, Collect blood samples for biochemical analysis and record the general body position measurement, blood pressure, blood lipid, blood sugar and other related changes of the subjects, and monitor the liver, kidney, and thyroid functions. |
| Placebo Capsules | Placebo comparator | Dietary Supplement: Placebo CapsulesMaltodextrin was used as a placebo. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Men or non-pregnant women over 20 years old (women of childbearing age are not allowed to become pregnant or breastfeed during the study) adults who are sane and able to communicate.
- 18≦BMI≦35.
- Blood routine examination (CBC; Complete blood count): the mean corpuscular volume MCV should not be less than 70 fL.
- Blood glucose level measurement meets any of the following conditions:
- The fasting blood sugar is between 100∼125 mg/dL, and the doctor judges that there is no need to use hypoglycemic drugs for the time being.
Key exclusion criteria (7 listed)
- Blood pressure: systolic blood pressure ≧ 200 mmHg or diastolic blood pressure ≧ 140 mmHg.
- Moderate or severe liver and kidney dysfunction (generally refers to serum aminopyruvate converting enzyme (SGPT) and serum glutamate phenylacetate transaminase (SGOT) are more than 3 times higher than the upper limit of normal value or have been diagnosed Liver cirrhosis, or glomerular filtration rate eGFR≦30 ml/min/1.73m2).
- Pregnant or lactating women.
- Diabetic patients taking hypoglycemic drugs or insulin injections.
- Those who take traditional Chinese medicine mainly red yeast rice.
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 |
|---|---|---|
| ANKASCIN 568-P Red yeast rice capsulesProduct ingredients: ANKASCIN 568-P red yeast rice product 440 mg,microcrystalline ,cellulose,Maltodextrin; capsule shell composition: HPMC (hydroxypropyl methylcellulose), purified water, titanium dioxide, gellan gum. | Dietary supplement | ANKASCIN 568-P Red yeast rice capsules |
| Placebo CapsulesMaltodextrin was used as a placebo | Dietary supplement | Placebo Capsules |
Primary outcome
Improve glycated hemoglobin (HbA1c) value
Time frame: 24 weeks
After 24 weeks of taking red yeast rice capsules or placebo gel, whether there is a statistical difference between the test group and the placebo group in terms of improving the HbA1c value of glycosylated hemoglobin.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Results publication: PubMed 24582683Hsu LC, Hsu YW, Hong CC, Pan TM. Safety and mutagenicity evaluation of red mold dioscorea fermented from Monascus purpureus NTU 568. Food Chem Toxicol. 2014 May;67:161-8. doi: 10.1016/j.fct.2014.02.033. Epub 2014 Feb 28.
- Results publication: PubMed 20557124Shi YC, Pan TM. Anti-diabetic effects of Monascus purpureus NTU 568 fermented products on streptozotocin-induced diabetic rats. J Agric Food Chem. 2010 Jul 14;58(13):7634-40. doi: 10.1021/jf101194f.
- Results publication: PubMed 20737515Shi YC, Pan TM. Antioxidant and pancreas-protective effect of red mold fermented products on streptozotocin-induced diabetic rats. J Sci Food Agric. 2010 Nov;90(14):2519-25. doi: 10.1002/jsfa.4115.
- Results publication: PubMed 21716679Shi YC, Liao JW, Pan TM. Antihypertriglyceridemia and anti-inflammatory activities of monascus-fermented dioscorea in streptozotocin-induced diabetic rats. Exp Diabetes Res. 2011;2011:710635. doi: 10.1155/2011/710635. Epub 2011 May 11.
- Results publication: PubMed 23673903Lee BH, Hsu WH, Huang T, Chang YY, Hsu YW, Pan TM. Monascin improves diabetes and dyslipidemia by regulating PPARgamma and inhibiting lipogenesis in fructose-rich diet-induced C57BL/6 mice. Food Funct. 2013 Jun;4(6):950-9. doi: 10.1039/c3fo60062a. Epub 2013 May 14.
- Results publication: PubMed 28911488Chen CL, Pan TM. Effects of red mold dioscorea with pioglitazone, a potentially functional food, in the treatment of diabetes. J Food Drug Anal. 2015 Dec;23(4):719-728. doi: 10.1016/j.jfda.2015.04.013. Epub 2015 Jul 21.
- Results publication: PubMed 19564463Slim R, Ben Salem C, Zamy M, Biour M. Pioglitazone-induced acute rhabdomyolysis. Diabetes Care. 2009 Jul;32(7):e84. doi: 10.2337/dc09-0593. No abstract available.
- Results publication: PubMed 28911684Wang YR, Liu SF, Shen YC, Chen CL, Huang CN, Pan TM, Wang CK. A randomized, double-blind clinical study to determine the effect of ANKASCIN 568 plus on blood glucose regulation. J Food Drug Anal. 2017 Apr;25(2):409-416. doi: 10.1016/j.jfda.2016.06.011. Epub 2016 Jul 30.
- Results publication: PubMed 29389579Liu SF, Wang YR, Shen YC, Chen CL, Huang CN, Pan TM, Wang CK. A randomized, double-blind clinical study of the effects of Ankascin 568 plus on blood lipid regulation. J Food Drug Anal. 2018 Jan;26(1):393-400. doi: 10.1016/j.jfda.2017.04.006. Epub 2017 Jun 1.
- 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.
WEN-HUI FANG, Ph. D. principal investigator
Chief of Family medicine department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ANKASCIN 568-P Red yeast rice capsules in people with High Blood Sugar and Metabolic Syndrome, run by SunWay Biotech Co., LTD. at 1 site in Taiwan.
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 10 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 28 Aug 2025. 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 Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sean Lin (02-27929568 ext. 612, sean.lin@sunway.cc), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improve glycated hemoglobin (HbA1c) value (time frame: 24 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 NCT05737342, which also lists 9 linked publications.
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 28 Aug 2025.