Clinical trial NCT05079529: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Cardiometabolic Syndrome
Keywords: β-1,3/1,6-D-Glucan
Polysaccharide Peptide
Ganoderma lucidum
Cardiometabolic syndrome
Lead sponsor: University of Brawijaya
Sponsor class: OTHER
Collaborators: name: PT. Sahabat Lingkungan Hidup
First posted: 2021-10-15
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Quality of Life from completion of SF-36 questionnaire
timeFrame: 0 and 90 days
Secondary outcomes:
measure: Change of inflammation status parameter (IL-6) level
timeFrame: 0 and 90 days
measure: Change of inflammation status parameter (TNF-alpha) level
timeFrame: 0 and 90 days
measure: Change of inflammation status parameter (hs-CRP) level
timeFrame: 0 and 90 days
measure: Change of oxidative stress parameter (MDA) level
timeFrame: 0 and 90 days
measure: Change of oxidative stress parameter (SOD) level
timeFrame: 0 and 90 days
measure: Change of endothelial function (NO) parameter level
timeFrame: 0 and 90 days
measure: Change of waist circumference measurement
timeFrame: 0 and 90 days
measure: Change of body weight and body height measurement
timeFrame: 0 and 90 days
measure: Change of blood pressure
timeFrame: 0 and 90 days
measure: Change of fasting glucose level
timeFrame: 0 and 90 days
measure: Change of HbA1C serum level
timeFrame: 0 and 90 days
measure: Change of triglicyride level status
timeFrame: 0 and 90 days
measure: Change of total cholesterol level status
timeFrame: 0 and 90 days
measure: Change of HDL level status
timeFrame: 0 and 90 days
measure: Change of LDL level status
timeFrame: 0 and 90 days
measure: Change of creatinine blood level
timeFrame: 0 and 90 days
measure: Change of urea blood level
timeFrame: 0 and 90 days
Other outcomes:
measure: Number of participants with adverse event (AEs)
timeFrame: 30, 60, and 90 days
measure: Number of participants with Serious Adverse Event (SAEs)
timeFrame: 30, 60, and 90 days
Locations:
city: Malang
country: Indonesia
facility: General Hospital of Brawijaya University (Rumah Sakit Universitas Brawijaya)
state: East Java
Study officials:
References:
citation: 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.
citation: 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.