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
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
70
Takes β-1,3/1,6-D-Glucan capsule 3 times daily for 90 days
Takes placebo capsule 3 times daily for 90 days
General Hospital of Brawijaya University (Rumah Sakit Universitas Brawijaya)
Malang, East Java, Indonesia
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
Time frame: 0 and 90 days
Change of inflammation status parameter (IL-6) level
Level of IL-6 is obtained from laboratory blood plasma test
Time frame: 0 and 90 days
Change of inflammation status parameter (TNF-alpha) level
Level of TNF-alpha is obtained from laboratory blood plasma test
Time frame: 0 and 90 days
Change of inflammation status parameter (hs-CRP) level
Level of hs-CRP is obtained from laboratory blood plasma test
Time frame: 0 and 90 days
Change of oxidative stress parameter (MDA) level
Level of MDA is obtained from laboratory blood plasma test
Time frame: 0 and 90 days
Change of oxidative stress parameter (SOD) level
Level of SOD is obtained from laboratory blood plasma test
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Time frame: 0 and 90 days
Change of endothelial function (NO) parameter level
Level of NO is obtained from laboratory blood plasma test
Time frame: 0 and 90 days
Change of waist circumference measurement
Waist circumference is measured by tape to determine abdominal obesity
Time frame: 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
Time frame: 0 and 90 days
Change of blood pressure
Blood pressure is measured using manual sphygmomanometer
Time frame: 0 and 90 days
Change of fasting glucose level
Fasting glucose level is obtained from laboratory blood test
Time frame: 0 and 90 days
Change of HbA1C serum level
HbA1C serum level is obtained from laboratory blood test
Time frame: 0 and 90 days
Change of triglicyride level status
Triglyceride level is obtained from laboratory blood test
Time frame: 0 and 90 days
Change of total cholesterol level status
Total cholesterol level is obtained from laboratory blood test
Time frame: 0 and 90 days
Change of HDL level status
HDL level is obtained from laboratory blood test
Time frame: 0 and 90 days
Change of LDL level status
LDL level is obtained from laboratory blood test
Time frame: 0 and 90 days
Change of creatinine blood level
Creatinine level is obtained from laboratory blood test
Time frame: 0 and 90 days
Change of urea blood level
Urea level is obtained from laboratory blood test
Time frame: 0 and 90 days