Cardiometabolic SyndromePhase 2NCT05079529
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
A Phase 2 study testing β-1,3/1,6-D-Glucan From Mycelia Extract of Indonesia's Ganoderma Lucidum Group in people with Cardiometabolic Syndrome, run by University of Brawijaya at 1 site in Indonesia.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiometabolic Syndrome
- What is being tested?
- β-1,3/1,6-D-Glucan From Mycelia Extract of Indonesia's Ganoderma Lucidum Group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteIndonesia
- Study dates
- 30 Jun 2021to 6 Jan 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
General Hospital of Brawijaya University (Rumah Sakit Universitas Brawijaya)
Malang, East Java, 65141
About this study
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
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
Read the 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.
- Conditions
- Cardiometabolic Syndrome
- Being tested
- β-1,3/1,6-D-Glucan From Mycelia Extract of Indonesia's Ganoderma Lucidum Group, Placebo Group
- Keywords
- β-1,3/1,6-D-Glucan, Polysaccharide Peptide, Ganoderma lucidum, Cardiometabolic syndrome
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
β-1,3/1,6-D-Glucan From Mycelia Extract of Indonesia's Ganoderma Lucidum GroupDrug
Also called β-1,3/1,6-D-Glucan
Takes β-1,3/1,6-D-Glucan capsule 3 times daily for 90 days
Placebo GroupDrug
Takes placebo capsule 3 times daily for 90 days
| Study group | Role | What they receive |
|---|---|---|
| β-1,3/1,6-D-Glucan From Mycelia Extract of Indonesia's Ganoderma Lucidum Group | Experimental | 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 Receives: Drug: β-1,3/1,6-D-Glucan From Mycelia Extract of Indonesia's Ganoderma Lucidum Group |
| Placebo Group | Placebo comparator | This group will receive empty capsule which will be taken 3 times daily for 90 days Receives: Drug: Placebo Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 0 and 90 days
Secondary outcomes (17)
Change of inflammation status parameter (IL-6) level
Level of IL-6 is obtained from laboratory blood plasma test
Measured: 0 and 90 days
Change of inflammation status parameter (TNF-alpha) level
Level of TNF-alpha is obtained from laboratory blood plasma test
Measured: 0 and 90 days
Change of inflammation status parameter (hs-CRP) level
Level of hs-CRP is obtained from laboratory blood plasma test
Measured: 0 and 90 days
Change of oxidative stress parameter (MDA) level
Level of MDA is obtained from laboratory blood plasma test
Measured: 0 and 90 days
Change of oxidative stress parameter (SOD) level
Level of SOD is obtained from laboratory blood plasma test
Measured: 0 and 90 days
Change of endothelial function (NO) parameter level
Level of NO is obtained from laboratory blood plasma test
Measured: 0 and 90 days
Change of waist circumference measurement
Waist circumference is measured by tape to determine abdominal obesity
Measured: 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
Measured: 0 and 90 days
Change of blood pressure
Blood pressure is measured using manual sphygmomanometer
Measured: 0 and 90 days
Change of fasting glucose level
Fasting glucose level is obtained from laboratory blood test
Measured: 0 and 90 days
Change of HbA1C serum level
HbA1C serum level is obtained from laboratory blood test
Measured: 0 and 90 days
Change of triglicyride level status
Triglyceride level is obtained from laboratory blood test
Measured: 0 and 90 days
Change of total cholesterol level status
Total cholesterol level is obtained from laboratory blood test
Measured: 0 and 90 days
Change of HDL level status
HDL level is obtained from laboratory blood test
Measured: 0 and 90 days
Change of LDL level status
LDL level is obtained from laboratory blood test
Measured: 0 and 90 days
Change of creatinine blood level
Creatinine level is obtained from laboratory blood test
Measured: 0 and 90 days
Change of urea blood level
Urea level is obtained from laboratory blood test
Measured: 0 and 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start30 Jun 2021
- Primary completion28 Dec 2021 (estimated)
- Study completion6 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiometabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Brawijaya
- Sponsor type
- University, hospital or other
- Collaborators
- PT. Sahabat Lingkungan Hidup
- Responsible party
- Principal investigator, Prof. Dr. dr. Djanggan Sargowo, Sp.PD, Sp.JP(K), University of Brawijaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05079529
- Sponsor's protocol ID
- MFBU.DS.PsP021
- Status last verified
- Oct 2021
- First submitted
- 18 Sep 2021
- Last updated
- 15 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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
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.
PubMed 25136585Kharroubi 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.
PubMed 26131326
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05079529
- Acronym / sponsor ID
- MFBU.DS.PsP021
- Conditions
- Cardiometabolic Syndrome
- Keywords
- β-1,3/1,6-D-Glucan, Polysaccharide Peptide, Ganoderma lucidum, Cardiometabolic syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of BrawijayaUniversity, hospital or other
- Collaborators
- PT. Sahabat Lingkungan Hidup
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 28 Dec 2021 (estimated)
- Study completion
- 6 Jan 2022 (estimated)
- First posted
- 15 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| β-1,3/1,6-D-Glucan From Mycelia Extract of Indonesia's Ganoderma Lucidum Group | Experimental | Drug: β-1,3/1,6-D-Glucan From Mycelia Extract of Indonesia's Ganoderma Lucidum GroupThis 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 |
| Placebo Group | Placebo comparator | Drug: Placebo GroupThis group will receive empty capsule which will be taken 3 times daily for 90 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| β-1,3/1,6-D-Glucan From Mycelia Extract of Indonesia's Ganoderma Lucidum GroupAlso: β-1,3/1,6-D-GlucanTakes β-1,3/1,6-D-Glucan capsule 3 times daily for 90 days | Drug | β-1,3/1,6-D-Glucan From Mycelia Extract of Indonesia's Ganoderma Lucidum Group |
| Placebo GroupTakes placebo capsule 3 times daily for 90 days | Drug | Placebo Group |
Primary outcome
Change in Quality of Life from completion of SF-36 questionnaire
Time frame: 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
17 secondary outcomes
Change of inflammation status parameter (IL-6) level
Time frame: 0 and 90 days
Change of inflammation status parameter (TNF-alpha) level
Time frame: 0 and 90 days
Change of inflammation status parameter (hs-CRP) level
Time frame: 0 and 90 days
Change of oxidative stress parameter (MDA) level
Time frame: 0 and 90 days
Change of oxidative stress parameter (SOD) level
Time frame: 0 and 90 days
Change of endothelial function (NO) parameter level
Time frame: 0 and 90 days
Change of waist circumference measurement
Time frame: 0 and 90 days
Change of body weight and body height measurement
Time frame: 0 and 90 days
Change of blood pressure
Time frame: 0 and 90 days
Change of fasting glucose level
Time frame: 0 and 90 days
Change of HbA1C serum level
Time frame: 0 and 90 days
Change of triglicyride level status
Time frame: 0 and 90 days
Change of total cholesterol level status
Time frame: 0 and 90 days
Change of HDL level status
Time frame: 0 and 90 days
Change of LDL level status
Time frame: 0 and 90 days
Change of creatinine blood level
Time frame: 0 and 90 days
Change of urea blood level
Time frame: 0 and 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.
- Results publication: PubMed 25136585Dinh 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.
- Results publication: PubMed 26131326Kharroubi 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.
- Journal Title: Vascular Inflammation and HypertensionLink provided by the sponsor.
- Standards of Medical Care in DiabetesLink provided by the sponsor.
- Journal Title: Pathophysiology, Diagnosis and Management of Diabetes MelitusLink provided by the sponsor.
- Journal Title: Hypertension: Pathophysiology and TreatmentLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. 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
Related trials for Cardiometabolic Syndrome
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
RecruitingPhase 1/2
The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function
Obesity, Metabolic Syndrome
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
RecruitingObservational study
Asprosin and miRNA Expression in Young Women With Metabolic Syndrome
Metabolic Syndrome, Insulin Resistance
Recruiting
Our Voices Matter: Intervention for Depression in Youth
Depressive Symptoms, Allostatic Load
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing β-1,3/1,6-D-Glucan From Mycelia Extract of Indonesia's Ganoderma Lucidum Group in people with Cardiometabolic Syndrome, run by University of Brawijaya at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quality of Life from completion of SF-36 questionnaire (time frame: 0 and 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05079529, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2021.