Effect of ANKASCIN 568-P Products on Decreasing HbA1c and Regulating Blood Glucose

NCT05737342 | Recruiting

• 1 other identifier: 22 ANKASCIN 568-P
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

High Blood Sugar; Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

• 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.

  24 weeks

Study Arms (2)

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.

Dietary Supplement: ANKASCIN 568-P Red yeast rice capsules

Placebo Capsules

PLACEBO COMPARATOR

Maltodextrin was used as a placebo.

Dietary Supplement: Placebo Capsules

Interventions

ANKASCIN 568-P Red yeast rice capsules DIETARY_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.

ANKASCIN 568-P Red yeast rice capsules

Placebo Capsules DIETARY_SUPPLEMENT

Maltodextrin was used as a placebo

Placebo Capsules

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• ≦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:
• (1) 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.
• (2) 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.
• (3) Diabetic patients who have no willingness to take medicine and have not taken hypoglycemic drugs in the past month.
• \. Those without other serious diseases (cancer, heart failure, myocardial infarction, liver cirrhosis, moderate to severe liver and kidney dysfunction, stroke, etc.).
• \. 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.
• \. During the test period, the daily routine and eating habits should be maintained without deliberately changing them.

You may not qualify if:

• 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.

Sponsors & Collaborators

• SunWay Biotech Co., LTD.: lead

Study Sites (1)

Tri-Service General Hospital, National Defense Medical Center, Taipei city,

Taipei, 114202, Taiwan

RECRUITING

Related Publications (9)

• 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.

  PMID: 24582683 RESULT

• Shi 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.

  PMID: 20557124 RESULT

• Shi 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.

  PMID: 20737515 RESULT

• Shi 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.

  PMID: 21716679 RESULT

• Lee 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.

  PMID: 23673903 RESULT

• Chen 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.

  PMID: 28911488 RESULT

• Slim 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.

  PMID: 19564463 RESULT

• Wang 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.

  PMID: 28911684 RESULT

• Liu 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.

  PMID: 29389579 RESULT

MeSH Terms

Conditions

Hyperglycemia; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Insulin Resistance; Hyperinsulinism

Study Officials

• WEN-HUI FANG, Ph. D.

  Chief of Family medicine department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sean Lin

CONTACT

02-27929568; sean.lin@sunway.cc

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This experiment adopts a block random assignment design, and the system assignment table (Block randomization, block size = 6) randomly generated by the program is given serial numbers and assigned to groups. The probability of assignment to each group is 1/2.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2023
• First Posted: February 21, 2023
• Study Start: April 1, 2023
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)