Development The Potentiality of β-1,3/1,6-D-Glucan (Polysaccharide Peptide) From Mycelia Extract of Indonesia's Ganoderma Lucidum as Adjuvant Therapy in Patients With Cardiometabolic Syndrome

Study Overview
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Brief Summary
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The aim of this study is to determine the role and efficacy of β-1,3/1,6-D-Glucan (Polysaccharide Peptide) from mycelia extract of Indonesia's Ganoderma lucidum as an antioxidant and anti-inflammatory agent on cardiometabolic syndrome

Detailed Description
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This study is held at Saiful Anwar General Hospital and General Hospital of Brawijaya University by enrolled 70 participants and using a double-blinded true experimental using a randomized control perspective method with pre-test and post-test design, to determine the effect of giving β-1,3/1,6-D-Glucan (Polysaccharide Peptide) from mycelia extract of Indonesia's Ganoderma lucidum on cardiometabolic syndrome population. The intended target or experimental variables that will be studied in this study are blood pressure, body mass index, blood glucose profile (fasting glucose, HbA1C), lipid profile (total cholesterol, High-Density Lipoprotein, Low-Density Lipoprotein, and triglyceride), renal function profile (urea and creatinine), heart function from echocardiography examination, inflammation parameter (Interleukin 6, Tumor Necrosis Factor-Alpha, and high sensitivity C-Reactive Protein), stress oxidative parameter (superoxide dismutase and malondialdehyde), endothelial function parameter (nitric oxide), and quality of life that conducted by completion of the SF-36 questionnaire. Hypothesis of this study is β-1,3/1,6-D-Glucan (Polysaccharide Peptide) from mycelia extract of Indonesia's Ganoderma lucidum can acts as a chronic anti-inflammatory and antioxidant agent in cardiometabolic syndrome patients by contributing in blood pressure control, body mass index control, blood glucose improvement, lipid profile improvement, renal function profile improvement, heart function improvement, and better quality of life. Beside that, the investigators hope that there will be a change of inflammation, stress oxidative, and endothelial function parameter in which shift to the good level.

Official Title
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Development The Potentiality of β-1,3/1,6-D-Glucan (Polysaccharide Peptide) From Mycelia Extract of Indonesia's Ganoderma Lucidum as Adjuvant Therapy in Patients With Cardiometabolic Syndrome Based on NCEP-ATP III Criteria With Modification on Obesity Classification (Waist Circumference Measurement) for Asian Population

Conditions
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Cardiometabolic Syndrome

Intervention / Treatment
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* Drug: β-1,3/1,6-D-Glucan From Mycelia Extract of Indonesia's Ganoderma Lucidum Group
* Drug: Placebo Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age more or same than 18 years old Defined as metabolic syndrome patients based on NCEP-ATP III Criteria with modified of obesity classification (waist measurement) for Asian population Agreed to participate in this study Exclusion Criteria: Allergic to Ganoderma lucidum Pregnant woman Participate in another drug or medical device study Waiting for an organ transplantation or have undergone a transplant Cancer patients who undergoing a chemotherapy or radiotherapy People with organ failure Could not be randomized and participate in this study by clinical judgement

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study conducted cardiometabolic syndrome patients based on NCEP-ATPIII criteria with modification of obesity classification to Asian population criteria. All of the participant would be divided into 2 groups/arms in which one group will be given Polysaccharide Peptide capsule 3 times daily for 90 days and the other one will be given Placebo in the same duration of time. Before Polysaccharide Peptide is given, there will be a sequence of pre-test examination, include: blood pressure measurement, body weight and body height measurement to determine Body Mass Index status, waist circumference measurement, blood glucose profile, lipid profile, renal function profile, parameter of inflammation status, parameter of oxidative stress, parameter of endothelial function, and completion of SF 36 questionnaire in which all of them will be done as post-test after intervention completed.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: β-1,3/1,6-D-Glucan From Mycelia Extract of Indonesia's Ganoderma Lucidum Group<br>This group will receive capsule contains 180 mg of β-1,3/1,6-D-Glucan From Mycelia Extract of Indonesia's Ganoderma lucidum which will be taken 3 times daily for 90 days | Drug: β-1,3/1,6-D-Glucan From Mycelia Extract of Indonesia's Ganoderma Lucidum Group<br>* Takes β-1,3/1,6-D-Glucan capsule 3 times daily for 90 days<br>* Other names: β-1,3/1,6-D-Glucan;|
| Placebo Comparator: Placebo Group<br>This group will receive empty capsule which will be taken 3 times daily for 90 days | Drug: Placebo Group<br>* Takes placebo capsule 3 times daily for 90 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of Life from completion of SF-36 questionnaire | Quality of Life is assessed by Indonesia validated Short Formm 36 questionnaire. This questionnaire consist of 36 items/questions that evaluate quality of life in some elements. The elements are consisted of changes in health (1 item), general health perception (5 items), energy/fatique (4 items), mental health (5 items), social functioning (2 items), pain (2 items), physical functioning (10 items), role limitations due to emotional problems (3 items) and role limitations due to physical problems (4 items). The score from each question will be summed. Minimum score is 36 and maximum score is 138. Higher score indicates higher quality of life and lower score indicates lower quality of life. Higher score after intervention in post-test examination represents a positive outcome | 0 and 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of inflammation status parameter (IL-6) level | Level of IL-6 is obtained from laboratory blood plasma test | 0 and 90 days | 
| Change of inflammation status parameter (TNF-alpha) level | Level of TNF-alpha is obtained from laboratory blood plasma test | 0 and 90 days | 
| Change of inflammation status parameter (hs-CRP) level | Level of hs-CRP is obtained from laboratory blood plasma test | 0 and 90 days | 
| Change of oxidative stress parameter (MDA) level | Level of MDA is obtained from laboratory blood plasma test | 0 and 90 days | 
| Change of oxidative stress parameter (SOD) level | Level of SOD is obtained from laboratory blood plasma test | 0 and 90 days | 
| Change of endothelial function (NO) parameter level | Level of NO is obtained from laboratory blood plasma test | 0 and 90 days | 
| Change of waist circumference measurement | Waist circumference is measured by tape to determine abdominal obesity | 0 and 90 days | 
| Change of body weight and body height measurement | Body weight is measured by body weight scale and body height is measured by body height scale, then will be combined to determine BMI in kg/m^2 | 0 and 90 days | 
| Change of blood pressure | Blood pressure is measured using manual sphygmomanometer | 0 and 90 days | 
| Change of fasting glucose level | Fasting glucose level is obtained from laboratory blood test | 0 and 90 days | 
| Change of HbA1C serum level | HbA1C serum level is obtained from laboratory blood test | 0 and 90 days | 
| Change of triglicyride level status | Triglyceride level is obtained from laboratory blood test | 0 and 90 days | 
| Change of total cholesterol level status | Total cholesterol level is obtained from laboratory blood test | 0 and 90 days | 
| Change of HDL level status | HDL level is obtained from laboratory blood test | 0 and 90 days | 
| Change of LDL level status | LDL level is obtained from laboratory blood test | 0 and 90 days | 
| Change of creatinine blood level | Creatinine level is obtained from laboratory blood test | 0 and 90 days | 
| Change of urea blood level | Urea level is obtained from laboratory blood test | 0 and 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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β-1,3/1,6-D-Glucan, Polysaccharide Peptide, Ganoderma lucidum, Cardiometabolic syndrome