Back to resultsEffect of Sago-based Product on Glycaemic and Lipid Control in Diabetes (SAGODM)
Primary Purpose
Diabetes Mellitus, Type 2
Status
Recruiting
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Sago starch drink
Corn starch drink
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring diabetes mellitus, resistant starch, sago, Sarawak, glycemic control, lipid control
Eligibility Criteria
Inclusion Criteria: 18 - 70 years old Individual diagnosed with type 2 diabetes for at least three months Not on any antidiabetic medications or on lifestyle modification or taking a stable dose of oral hypoglycaemic agents, with no change of dose and regime for the past eight weeks Has HbA1C values of 6.5 - 8.5% within 28 days before commencing the study Able to complete the clinical study, and Able to provide written informed consent Exclusion Criteria: History of allergy to sago starch or corn starch History of allergy to any other ingredients in the study foods Clinically significant, active and acute cardiovascular disease Clinically significant, stage 4 - 5 (estimated glomerular filtration rate <30mL/min/1.73m2), chronic kidney failure Clinically significant chronic liver disease or infection Any malignancies Regular use of hormone medications, anti-inflammatory medication, steroids, or other medications that might interfere with outcome measure On a prescribed therapeutic diet Taking part in weight loss programme Clinically significant abnormal laboratory investigations Other medical conditions or reasons, in the opinion of the Investigator or Research Physician, that make one unsuitable to join the study Concurrent participation in other clinical studies involving intervention or treatment towards obesity, diabetes or impaired glucose Pregnant or lactating mothers
Sites / Locations
- Klinik Kesihatan Batu KawahRecruiting
- Klinik Kesihatan Jalan MasjidRecruiting
- Klinik Kesihatan Tanah PutehRecruiting
- Sarawak General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intervention Arm
Control Arm
Arm Description
Subjects who are randomised to Intervention Arm will be taking a drink containing 25g of Sarawak sago starch in 200mL of plain water. The subjects will take the drink twice daily i.e., within 30 minutes before lunch and dinner. On top of that, they will be counselled on diet recommendations for diabetes by a study dietitian at Visit 1 or baseline.
Subjects who are randomised to Control Arm will be taking a drink containing 25g of corn starch in 200mL of water. The subjects will take the starch suspension twice daily i.e., within 30 minutes before lunch and dinner. On top of that, they will be counselled on diet recommendation for diabetes by a study dietitian at Visit 1 or baseline.
Outcomes
Primary Outcome Measures
Change of HbA1C value
The change of HbA1C value at 12 weeks of intervention from baseline
Change of fasting blood glucose (FBG) level
The change of FBG level at 12 weeks of intervention from baseline
Change of homeostasis model assessment (HOMA) of insulin resistance (HOMA-IR) value
The change of HOMA of insulin resistant value at 12 weeks of intervention from baseline
Change of triglycerides level
The change of triglycerides level at 12 weeks of intervention from baseline
Change of total cholesterol level
The change of total cholesterol level at 12 weeks of intervention from baseline
Change of low density lipoprotein cholesterol (LDL-C) level
The change of LDL-C level at 12 weeks of intervention from baseline
Change of high density lipoprotein cholesterol (HDL-C) level
The change of HDL-C level at 12 weeks of intervention from baseline
Secondary Outcome Measures
Change of inflammatory marker levels: high-sensitive c-reactive protein (hs-CRP) level
The change of hs-CRP level at 12 weeks of intervention from baseline
Change of inflammatory marker levels: interleukin 6 (IL-6) level
The change of IL-6 level at 12 weeks of intervention from baseline
Change of inflammatory marker levels: blood ferritin level
The change of blood ferritin level at 12 weeks of intervention from baseline
Change of total daily calorie intake
The change of total daily calorie intake at 12 weeks of intervention from baseline
Change of body weight/body mass index (BMI)
The change of BMI at 12 weeks of intervention from baseline
Change of body fat and visceral fat percentages
The change of body fat and visceral fat percentages at 12 weeks of intervention from baseline
Change of waist-hip ratio from baseline
The change of waist-hip ratio at 12 weeks of intervention from baseline
Change of blood pressure from baseline
The change of systolic and diastolic blood pressure at 12 weeks of intervention from baseline
Change of heart rate from baseline
The change of heart rate at 12 weeks of intervention from baseline
Full Information
NCT ID
NCT05599633
First Posted
October 26, 2022
Last Updated
January 29, 2023
Sponsor
Sarawak General Hospital
Collaborators
CRAUN Research Sdn. Bhd.
1. Study Identification
Unique Protocol Identification Number
NCT05599633
Brief Title
Effect of Sago-based Product on Glycaemic and Lipid Control in Diabetes
Acronym
SAGODM
Official Title
Effect of 12 Weeks Consumption of Sago Based Products in A Malaysian Diet on Glycaemic and Lipid Control in Diabetic Patients: A Double-Blind, Randomised, Parallel Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 10, 2022 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sarawak General Hospital
Collaborators
CRAUN Research Sdn. Bhd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This will be a parallel, randomised, double-blind, controlled trial. Upon successful screening, subjects will be randomised to either intervention arm or control arm in a ratio of 1:1. The subjects will consume either a drink containing 25g of Sarawak sago starch (intervention) or 25g of corn starch (control) in approximately 200mL of water, two times a day, before lunch and dinner for 12 weeks, in addition to a standardised dietary counselling for diabetes given by the hospital dietitian at baseline. The study endpoints will be evaluated after 12 weeks of starch consumption.
Detailed Description
SAGODM trial is a parallel, randomised, double-blind, controlled trial on the effect of consuming sago starch for 12 weeks on glycaemic and lipid control in patients with type 2 diabetes mellitus. Diabetic patients who had HbA1C between 6.5% and 8.5% and had no change in the antidiabetic treatment for the past two months (primary inclusion criteria) were invited to participate in the trial. They were randomised to either the intervention arm or control arm in a ratio of 1:1. The subjects will consume either a drink containing 25g of Sarawak sago starch (intervention) or 25g of corn starch (control) in approximately 200mL of water, two times a day, before lunch and dinner for 12 weeks. They will receive standardised dietary counselling for diabetes given by the hospital dietitian at baseline. They will also be asked to record their dietary intake for three consecutive days every month. Blood samples will be taken at baseline and the last visit (post-12 weeks). The study endpoints will be evaluated after 12 weeks of starch consumption.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
diabetes mellitus, resistant starch, sago, Sarawak, glycemic control, lipid control
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
Intervention (Sago starch) and control (corn starch) will be packed in individual aluminium sachets and will not be distinguishable from each other. The included subjects and investigators will be blinded from the study arm assignment. Randomisation and dispensation of the study starch will be done by the unblinded pharmacists only, who will not be involved in the care of the patients and study endpoint assessments.
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention Arm
Arm Type
Experimental
Arm Description
Subjects who are randomised to Intervention Arm will be taking a drink containing 25g of Sarawak sago starch in 200mL of plain water. The subjects will take the drink twice daily i.e., within 30 minutes before lunch and dinner. On top of that, they will be counselled on diet recommendations for diabetes by a study dietitian at Visit 1 or baseline.
Arm Title
Control Arm
Arm Type
Placebo Comparator
Arm Description
Subjects who are randomised to Control Arm will be taking a drink containing 25g of corn starch in 200mL of water. The subjects will take the starch suspension twice daily i.e., within 30 minutes before lunch and dinner. On top of that, they will be counselled on diet recommendation for diabetes by a study dietitian at Visit 1 or baseline.
Intervention Type
Dietary Supplement
Intervention Name(s)
Sago starch drink
Intervention Description
Sarawak sago starch drink will be provided by CRAUN throughout the study. The starch drink will be supplied in sealed aluminium sachets. Each sachet contains 25g of study starch with cocoa flavouring.
Intervention Type
Dietary Supplement
Intervention Name(s)
Corn starch drink
Intervention Description
Corn starch drink will be provided by CRAUN throughout the study. The starch drink will be supplied in sealed aluminium sachets. Each sachet contains 25g of study starch with cocoa flavouring.
Primary Outcome Measure Information:
Title
Change of HbA1C value
Description
The change of HbA1C value at 12 weeks of intervention from baseline
Time Frame
12 weeks
Title
Change of fasting blood glucose (FBG) level
Description
The change of FBG level at 12 weeks of intervention from baseline
Time Frame
12 weeks
Title
Change of homeostasis model assessment (HOMA) of insulin resistance (HOMA-IR) value
Description
The change of HOMA of insulin resistant value at 12 weeks of intervention from baseline
Time Frame
12 weeks
Title
Change of triglycerides level
Description
The change of triglycerides level at 12 weeks of intervention from baseline
Time Frame
12 weeks
Title
Change of total cholesterol level
Description
The change of total cholesterol level at 12 weeks of intervention from baseline
Time Frame
12 weeks
Title
Change of low density lipoprotein cholesterol (LDL-C) level
Description
The change of LDL-C level at 12 weeks of intervention from baseline
Time Frame
12 weeks
Title
Change of high density lipoprotein cholesterol (HDL-C) level
Description
The change of HDL-C level at 12 weeks of intervention from baseline
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change of inflammatory marker levels: high-sensitive c-reactive protein (hs-CRP) level
Description
The change of hs-CRP level at 12 weeks of intervention from baseline
Time Frame
12 weeks
Title
Change of inflammatory marker levels: interleukin 6 (IL-6) level
Description
The change of IL-6 level at 12 weeks of intervention from baseline
Time Frame
12 weeks
Title
Change of inflammatory marker levels: blood ferritin level
Description
The change of blood ferritin level at 12 weeks of intervention from baseline
Time Frame
12 weeks
Title
Change of total daily calorie intake
Description
The change of total daily calorie intake at 12 weeks of intervention from baseline
Time Frame
12 weeks
Title
Change of body weight/body mass index (BMI)
Description
The change of BMI at 12 weeks of intervention from baseline
Time Frame
12 weeks
Title
Change of body fat and visceral fat percentages
Description
The change of body fat and visceral fat percentages at 12 weeks of intervention from baseline
Time Frame
12 weeks
Title
Change of waist-hip ratio from baseline
Description
The change of waist-hip ratio at 12 weeks of intervention from baseline
Time Frame
12 weeks
Title
Change of blood pressure from baseline
Description
The change of systolic and diastolic blood pressure at 12 weeks of intervention from baseline
Time Frame
12 weeks
Title
Change of heart rate from baseline
Description
The change of heart rate at 12 weeks of intervention from baseline
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 - 70 years old
Individual diagnosed with type 2 diabetes for at least three months
Not on any antidiabetic medications or on lifestyle modification or taking a stable dose of oral hypoglycaemic agents, with no change of dose and regime for the past eight weeks
Has HbA1C values of 6.5 - 8.5% within 28 days before commencing the study
Able to complete the clinical study, and
Able to provide written informed consent
Exclusion Criteria:
History of allergy to sago starch or corn starch
History of allergy to any other ingredients in the study foods
Clinically significant, active and acute cardiovascular disease
Clinically significant, stage 4 - 5 (estimated glomerular filtration rate <30mL/min/1.73m2), chronic kidney failure
Clinically significant chronic liver disease or infection
Any malignancies
Regular use of hormone medications, anti-inflammatory medication, steroids, or other medications that might interfere with outcome measure
On a prescribed therapeutic diet
Taking part in weight loss programme
Clinically significant abnormal laboratory investigations
Other medical conditions or reasons, in the opinion of the Investigator or Research Physician, that make one unsuitable to join the study
Concurrent participation in other clinical studies involving intervention or treatment towards obesity, diabetes or impaired glucose
Pregnant or lactating mothers
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Teck Long King
Phone
60168911615
Email
kingtl@crc.moh.gov.my
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xun Ting Tiong
Organizational Affiliation
Clinical Research Centre Sarawak General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinik Kesihatan Batu Kawah
City
Kuching
State/Province
Sarawak
ZIP/Postal Code
93250
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Azreen Abdullah
Phone
6082688518
First Name & Middle Initial & Last Name & Degree
Azreen Abdullah
Facility Name
Klinik Kesihatan Jalan Masjid
City
Kuching
State/Province
Sarawak
ZIP/Postal Code
93400
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maila Mustapha
Phone
6082427110
First Name & Middle Initial & Last Name & Degree
Maila Mustapha
Facility Name
Klinik Kesihatan Tanah Puteh
City
Kuching
State/Province
Sarawak
ZIP/Postal Code
93400
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muhamad Irfan Yasin Ali Uddin
Phone
6082344011
First Name & Middle Initial & Last Name & Degree
Muhamad Irfan Yasin Ali Uddin
First Name & Middle Initial & Last Name & Degree
Peter Jerampang
Facility Name
Sarawak General Hospital
City
Kuching
State/Province
Sarawak
ZIP/Postal Code
93586
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Director
Phone
6082276666
Ext
1011
Email
sgh@moh.gov.my
First Name & Middle Initial & Last Name & Degree
Teck Long King
First Name & Middle Initial & Last Name & Degree
Florence Hui Sieng Tan
First Name & Middle Initial & Last Name & Degree
Leh Siang Yeo
First Name & Middle Initial & Last Name & Degree
Jawing Chunggat
First Name & Middle Initial & Last Name & Degree
Pei Yong Chan
First Name & Middle Initial & Last Name & Degree
Sing Yee Khoo
First Name & Middle Initial & Last Name & Degree
John Yeo
First Name & Middle Initial & Last Name & Degree
Ngan Kai Liew
First Name & Middle Initial & Last Name & Degree
Xun Ting Tiong
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Sago-based Product on Glycaemic and Lipid Control in Diabetes
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