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

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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Cardiometabolic Syndrome
• Intervention / Treatment: Drug: β-1,3/1,6-D-Glucan From Mycelia Extract of Indonesia's Ganoderma Lucidum Group; Drug: Placebo Group

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Phase 2

Contacts and Locations

Study Locations

• Indonesia
  • East Java
    • Malang, East Java, Indonesia, 65141
      • General Hospital of Brawijaya University (Rumah Sakit Universitas Brawijaya)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

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; 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; Takes β-1,3/1,6-D-Glucan capsule 3 times daily for 90 days; Other Names: β-1,3/1,6-D-Glucan
Placebo Comparator: Placebo Group; This group will receive empty capsule which will be taken 3 times daily for 90 days	Drug: Placebo Group; Takes placebo capsule 3 times daily for 90 days

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with adverse event (AEs)	Number of participants that experience adverse event in this study	30, 60, and 90 days
Number of participants with Serious Adverse Event (SAEs)	Number of participants that go through serious adverse event in this study	30, 60, and 90 days

Collaborators and Investigators

• Sponsor: University of Brawijaya
• Collaborators: PT. Sahabat Lingkungan Hidup

Publications and helpful links

General Publications

• Dinh QN, Drummond GR, Sobey CG, Chrissobolis S. Roles of inflammation, oxidative stress, and vascular dysfunction in hypertension. Biomed Res Int. 2014;2014:406960. doi: 10.1155/2014/406960. Epub 2014 Jul 20.
• Kharroubi AT, Darwish HM. Diabetes mellitus: The epidemic of the century. World J Diabetes. 2015 Jun 25;6(6):850-67. doi: 10.4239/wjd.v6.i6.850.

Helpful Links

• Journal Title: Vascular Inflammation and Hypertension
• Standards of Medical Care in Diabetes
• Journal Title: Pathophysiology, Diagnosis and Management of Diabetes Melitus
• Journal Title: Hypertension: Pathophysiology and Treatment
• CDC Grand Rounds: A Public Health Approach to Detect and Control Hypertension

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2021
• Primary Completion (Anticipated): December 28, 2021
• Study Completion (Anticipated): January 6, 2022

Study Registration Dates

• First Submitted: September 18, 2021
• First Submitted That Met QC Criteria: October 3, 2021
• First Posted (Actual): October 15, 2021

Study Record Updates

• Last Update Posted (Actual): October 15, 2021
• Last Update Submitted That Met QC Criteria: October 3, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Ganoderma lucidum; β-1,3/1,6-D-Glucan; Polysaccharide Peptide; Cardiometabolic syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: MFBU.DS.PsP021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: The research team would like to discuss to what extent and the criteria of individual participant data that will be shared related to Statistical Analysis Plan, Informed Consent Form and/or Clinical Study Report

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No