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

Primary Purpose

High Blood Sugar, Metabolic Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ANKASCIN 568-P Red yeast rice capsules
Placebo Capsules
Sponsored by
SunWay Biotech Co., LTD.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for High Blood Sugar

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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: (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. 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 If the condition changes and the use of hypoglycemic drugs is required, the trial must be withdrawn. 7.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. Exclusion Criteria: 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    ANKASCIN 568-P Red yeast rice capsules

    Placebo Capsules

    Arm Description

    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.

    Maltodextrin was used as a placebo.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 10, 2023
    Last Updated
    March 2, 2023
    Sponsor
    SunWay Biotech Co., LTD.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05737342
    Brief Title
    Effect of ANKASCIN 568-P Products on Decreasing HbA1c and Regulating Blood Glucose
    Official Title
    Effect of ANKASCIN 568-P Products on Decreasing HbA1c and Regulating Blood Glucose- A Double-blind, Placebo-controlled Clinical Research
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 1, 2023 (Anticipated)
    Primary Completion Date
    March 31, 2025 (Anticipated)
    Study Completion Date
    May 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    SunWay Biotech Co., LTD.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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)
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    High Blood Sugar, Metabolic Syndrome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Masking Description
    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.
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    ANKASCIN 568-P Red yeast rice capsules
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Placebo Capsules
    Arm Type
    Placebo Comparator
    Arm Description
    Maltodextrin was used as a placebo.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    ANKASCIN 568-P Red yeast rice capsules
    Intervention Description
    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.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Placebo Capsules
    Intervention Description
    Maltodextrin was used as a placebo
    Primary Outcome Measure Information:
    Title
    Improve glycated hemoglobin (HbA1c) value
    Description
    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.
    Time Frame
    24 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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: (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. 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. Exclusion Criteria: 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sean Lin
    Phone
    02-27929568
    Ext
    612
    Email
    sean.lin@sunway.cc
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    WEN-HUI FANG, Ph. D.
    Organizational Affiliation
    Chief of Family medicine department
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    24582683
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    20557124
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    20737515
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    21716679
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    23673903
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    28911488
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    19564463
    Citation
    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. Erratum In: Diabetes Care. 2010 Jun;33(6):1406. Zami, Michele [corrected to Zamy, Michele].
    Results Reference
    result
    PubMed Identifier
    28911684
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    29389579
    Citation
    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.
    Results Reference
    result

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

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