search
Back to results

Effect of ANKASCIN 568-P Products Regulating Blood Lipid

Primary Purpose

Hyperlipidemias

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 Hyperlipidemias

Eligibility Criteria

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

Inclusion Criteria: Male or Female women over the age of 20 (women of childbearing age should not be pregnant or breastfeeding during the study period). A sane and communicative adult. 18≦BMI≦35. Sub-healthy people with simple dyslipidemia and those who have been judged by the doctor that they do not need to take hypolipidemic drugs for the time being, or those who insist on not taking drugs. Screening criteria Low-density lipoprotein cholesterol (LDL-C): 130~190 mg/dL. screening criteria and high-density lipoprotein cholesterol (HLDL-C): below 50 mg/dL. Those without other serious diseases (cancer, heart failure, diabetes, myocardial infarction, liver cirrhosis, moderate to severe liver and kidney dysfunction, stroke, etc.). During the experiment, the daily routine and eating habits should be maintained and not changed deliberately. Exclusion Criteria: Triglyceride TG≧500 mg/dL. Blood pressure value: systolic blood pressure ≧ 200 mmHg or diastolic blood pressure ≧ 140 mmHg. Patients with moderate or severe abnormal liver and kidney function (generally referring to serum aminopyruvate converting enzyme (SGPT), serum glutamate phenylacetate transaminase (SGOT) are more than 3 times the upper limit of normal or have been diagnosed Liver cirrhosis, or glomerular filtration rate eGFR≦30 ml/min/1.73m2). Pregnant or lactating women. Those who take traditional Chinese medicine mainly based on red yeast rice. Those who have undergone surgery within one month. Those who have serious diseases such as heart, liver, kidney, and hematopoietic system, mentally ill patients who do not meet the inclusion criteria, fail to use the test product according to the regulations so that the efficacy or safety cannot be judged due to incomplete data.

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

    Improves total cholesterol (TC)
    Compare the improvement of total cholesterol (TC) between the test group and the placebo group after taking red yeast rice capsules or placebo capsules for 24 weeks. According to the results of Section 9. Statistical method, whether there is a statistical difference between the two groups.

    Secondary Outcome Measures

    Full Information

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

    1. Study Identification

    Unique Protocol Identification Number
    NCT05737355
    Brief Title
    Effect of ANKASCIN 568-P Products Regulating Blood Lipid
    Official Title
    Effect of ANKASCIN 568-P Products Regulating Blood Lipid- 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 experiment hopes to understand the effect of long-term consumption of red yeast rice products on blood lipid regulation and high-density lipoprotein cholesterol (HDL-C) elevation and to monitor the changes in the subjects' overall health status. This case is a randomized, double-blind, placebo-controlled trial. It is expected to recruit 80 subjects and randomly assign them to 2 groups to take red yeast rice products or a placebo for 24 weeks. The test group takes one red yeast rice capsule (containing 220 mg ANKASCIN 568-P), the control group took a placebo capsule of similar appearance (containing an equal weight of maltodextrin) every day, and blood samples were collected at 0, 4, and 12, 24, weeks for biochemical analysis and recorded. Subjects' general body position measurement, blood pressure, blood lipids, blood sugar and other related changes, and monitoring of liver, kidney, and thyroid function.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hyperlipidemias

    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
    Improves total cholesterol (TC)
    Description
    Compare the improvement of total cholesterol (TC) between the test group and the placebo group after taking red yeast rice capsules or placebo capsules for 24 weeks. According to the results of Section 9. Statistical method, whether there is a statistical difference between the two groups.
    Time Frame
    24 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male or Female women over the age of 20 (women of childbearing age should not be pregnant or breastfeeding during the study period). A sane and communicative adult. 18≦BMI≦35. Sub-healthy people with simple dyslipidemia and those who have been judged by the doctor that they do not need to take hypolipidemic drugs for the time being, or those who insist on not taking drugs. Screening criteria Low-density lipoprotein cholesterol (LDL-C): 130~190 mg/dL. screening criteria and high-density lipoprotein cholesterol (HLDL-C): below 50 mg/dL. Those without other serious diseases (cancer, heart failure, diabetes, myocardial infarction, liver cirrhosis, moderate to severe liver and kidney dysfunction, stroke, etc.). During the experiment, the daily routine and eating habits should be maintained and not changed deliberately. Exclusion Criteria: Triglyceride TG≧500 mg/dL. Blood pressure value: systolic blood pressure ≧ 200 mmHg or diastolic blood pressure ≧ 140 mmHg. Patients with moderate or severe abnormal liver and kidney function (generally referring to serum aminopyruvate converting enzyme (SGPT), serum glutamate phenylacetate transaminase (SGOT) are more than 3 times the upper limit of normal or have been diagnosed Liver cirrhosis, or glomerular filtration rate eGFR≦30 ml/min/1.73m2). Pregnant or lactating women. Those who take traditional Chinese medicine mainly based on red yeast rice. Those who have undergone surgery within one month. Those who have serious diseases such as heart, liver, kidney, and hematopoietic system, mentally ill patients who do not meet the inclusion criteria, fail to use the test product according to the regulations so that the efficacy or safety cannot be judged due to incomplete data.
    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
    29184622
    Citation
    Hajar R. Risk Factors for Coronary Artery Disease: Historical Perspectives. Heart Views. 2017 Jul-Sep;18(3):109-114. doi: 10.4103/HEARTVIEWS.HEARTVIEWS_106_17. No abstract available.
    Results Reference
    result
    PubMed Identifier
    18038131
    Citation
    Lin YL, Wang TH, Lee MH, Su NW. Biologically active components and nutraceuticals in the Monascus-fermented rice: a review. Appl Microbiol Biotechnol. 2008 Jan;77(5):965-73. doi: 10.1007/s00253-007-1256-6. Epub 2007 Nov 22.
    Results Reference
    result
    PubMed Identifier
    20147729
    Citation
    Echaniz-Laguna A, Mohr M, Tranchant C. Neuromuscular symptoms and elevated creatine kinase after statin withdrawal. N Engl J Med. 2010 Feb 11;362(6):564-5. doi: 10.1056/NEJMc0908215. No abstract available.
    Results Reference
    result
    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
    23360447
    Citation
    Lee CL, Wen JY, Hsu YW, Pan TM. Monascus-fermented yellow pigments monascin and ankaflavin showed antiobesity effect via the suppression of differentiation and lipogenesis in obese rats fed a high-fat diet. J Agric Food Chem. 2013 Feb 20;61(7):1493-500. doi: 10.1021/jf304015z. Epub 2013 Feb 8.
    Results Reference
    result
    PubMed Identifier
    20666456
    Citation
    Lee CL, Kung YH, Wu CL, Hsu YW, Pan TM. Monascin and ankaflavin act as novel hypolipidemic and high-density lipoprotein cholesterol-raising agents in red mold dioscorea. J Agric Food Chem. 2010 Aug 25;58(16):9013-9. doi: 10.1021/jf101982v. Epub 2010 Jul 28.
    Results Reference
    result
    PubMed Identifier
    23237237
    Citation
    Lee CL, Hung YP, Hsu YW, Pan TM. Monascin and ankaflavin have more anti-atherosclerosis effect and less side effect involving increasing creatinine phosphokinase activity than monacolin K under the same dosages. J Agric Food Chem. 2013 Jan 9;61(1):143-50. doi: 10.1021/jf304346r. Epub 2012 Dec 24.
    Results Reference
    result
    PubMed Identifier
    23107730
    Citation
    Chen CL, Pan TM. Red mold dioscorea: a potentially safe traditional function food for the treatment of hyperlipidemia. Food Chem. 2012 Sep 15;134(2):1074-80. doi: 10.1016/j.foodchem.2012.03.019. Epub 2012 Mar 16.
    Results Reference
    result
    PubMed Identifier
    27422746
    Citation
    Lee CL, Wen JY, Hsu YW, Pan TM. The blood lipid regulation of Monascus-produced monascin and ankaflavin via the suppression of low-density lipoprotein cholesterol assembly and stimulation of apolipoprotein A1 expression in the liver. J Microbiol Immunol Infect. 2018 Feb;51(1):27-37. doi: 10.1016/j.jmii.2016.06.003. Epub 2016 Jun 24.
    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

    Learn more about this trial

    Effect of ANKASCIN 568-P Products Regulating Blood Lipid

    We'll reach out to this number within 24 hrs