Cardiometabolic Syndrome
Conditions
Keywords
β-1,3/1,6-D-Glucan, Polysaccharide Peptide, Ganoderma lucidum, Cardiometabolic syndrome
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.
Interventions
DRUGβ-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
DRUGPlacebo Group
Takes placebo capsule 3 times daily for 90 days
Sponsors
PT. Sahabat Lingkungan Hidup
University of Brawijaya
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
This study is randomized control double-blinded true experimental study. So the only party that acknowledge whom is given Polysaccharide Peptide capsule or Placebo is the collaborator who provides the adjuvant therapy agent. There is an exception for Outcomes Assessor. They might ask for detail description of the intervention that have been given to the participant if there is any serious adverse event going on.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life from completion of SF-36 questionnaire | 0 and 90 days | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of inflammation status parameter (IL-6) level | 0 and 90 days | Level of IL-6 is obtained from laboratory blood plasma test |
| Change of inflammation status parameter (TNF-alpha) level | 0 and 90 days | Level of TNF-alpha is obtained from laboratory blood plasma test |
| Change of inflammation status parameter (hs-CRP) level | 0 and 90 days | Level of hs-CRP is obtained from laboratory blood plasma test |
| Change of oxidative stress parameter (MDA) level | 0 and 90 days | Level of MDA is obtained from laboratory blood plasma test |
| Change of oxidative stress parameter (SOD) level | 0 and 90 days | Level of SOD is obtained from laboratory blood plasma test |
| Change of endothelial function (NO) parameter level | 0 and 90 days | Level of NO is obtained from laboratory blood plasma test |
| Change of waist circumference measurement | 0 and 90 days | Waist circumference is measured by tape to determine abdominal obesity |
| Change of body weight and body height measurement | 0 and 90 days | 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 |
| Change of blood pressure | 0 and 90 days | Blood pressure is measured using manual sphygmomanometer |
| Change of creatinine blood level | 0 and 90 days | Creatinine level is obtained from laboratory blood test |
| Change of urea blood level | 0 and 90 days | Urea level is obtained from laboratory blood test |
| Change of fasting glucose level | 0 and 90 days | Fasting glucose level is obtained from laboratory blood test |
| Change of HbA1C serum level | 0 and 90 days | HbA1C serum level is obtained from laboratory blood test |
| Change of triglicyride level status | 0 and 90 days | Triglyceride level is obtained from laboratory blood test |
| Change of total cholesterol level status | 0 and 90 days | Total cholesterol level is obtained from laboratory blood test |
| Change of HDL level status | 0 and 90 days | HDL level is obtained from laboratory blood test |
| Change of LDL level status | 0 and 90 days | LDL level is obtained from laboratory blood test |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with Serious Adverse Event (SAEs) | 30, 60, and 90 days | Number of participants that go through serious adverse event in this study |
| Number of participants with adverse event (AEs) | 30, 60, and 90 days | Number of participants that experience adverse event in this study |
Countries
Indonesia
Outcome results
None listed