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

Cardiometabolic Syndrome Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05079529
• Other study ID #: MFBU.DS.PsP021
• Status: Enrolling by invitation
• Phase: Phase 2
• Start date: June 30, 2021
• Est. completion date: January 6, 2022

Study information

• Verified date: October 2021
• Source: University of Brawijaya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 70
• Est. completion date: January 6, 2022
• Est. primary completion date: December 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiometabolic Syndrome
• Metabolic Syndrome
• Syndrome

Intervention

Drug:
• ß-1,3/1,6-D-Glucan From Mycelia Extract of Indonesia's Ganoderma Lucidum Group
Takes ß-1,3/1,6-D-Glucan capsule 3 times daily for 90 days
• Placebo Group
Takes placebo capsule 3 times daily for 90 days

Locations

Country	Name	City	State
Indonesia	General Hospital of Brawijaya University (Rumah Sakit Universitas Brawijaya)	Malang	East Java

Sponsors (2)

Lead Sponsor	Collaborator
University of Brawijaya	PT. Sahabat Lingkungan Hidup

Country where clinical trial is conducted

Indonesia, 

References & Publications (2)

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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants with adverse event (AEs)	Number of participants that experience adverse event in this study	30, 60, and 90 days
Other	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
Primary	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	Change of inflammation status parameter (IL-6) level	Level of IL-6 is obtained from laboratory blood plasma test	0 and 90 days
Secondary	Change of inflammation status parameter (TNF-alpha) level	Level of TNF-alpha is obtained from laboratory blood plasma test	0 and 90 days
Secondary	Change of inflammation status parameter (hs-CRP) level	Level of hs-CRP is obtained from laboratory blood plasma test	0 and 90 days
Secondary	Change of oxidative stress parameter (MDA) level	Level of MDA is obtained from laboratory blood plasma test	0 and 90 days
Secondary	Change of oxidative stress parameter (SOD) level	Level of SOD is obtained from laboratory blood plasma test	0 and 90 days
Secondary	Change of endothelial function (NO) parameter level	Level of NO is obtained from laboratory blood plasma test	0 and 90 days
Secondary	Change of waist circumference measurement	Waist circumference is measured by tape to determine abdominal obesity	0 and 90 days
Secondary	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
Secondary	Change of blood pressure	Blood pressure is measured using manual sphygmomanometer	0 and 90 days
Secondary	Change of fasting glucose level	Fasting glucose level is obtained from laboratory blood test	0 and 90 days
Secondary	Change of HbA1C serum level	HbA1C serum level is obtained from laboratory blood test	0 and 90 days
Secondary	Change of triglicyride level status	Triglyceride level is obtained from laboratory blood test	0 and 90 days
Secondary	Change of total cholesterol level status	Total cholesterol level is obtained from laboratory blood test	0 and 90 days
Secondary	Change of HDL level status	HDL level is obtained from laboratory blood test	0 and 90 days
Secondary	Change of LDL level status	LDL level is obtained from laboratory blood test	0 and 90 days
Secondary	Change of creatinine blood level	Creatinine level is obtained from laboratory blood test	0 and 90 days
Secondary	Change of urea blood level	Urea level is obtained from laboratory blood test	0 and 90 days

External Links

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