An interventional study of Sago starch drink and Corn starch drink in Diabetes Mellitus, Type 2, sponsored by Sarawak General Hospital. Completed at 4 sites in Malaysia. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-12-02.
Sponsored by Sarawak General Hospital · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
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.
Dietary Supplement: Sago starch drink
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.
Dietary Supplement: Corn starch drink
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.
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.
Change of HbA1C value
The change of HbA1C value at 12 weeks of intervention from baseline
Time frame: 12 weeks
Change of fasting blood glucose (FBG) level
The change of FBG level at 12 weeks of intervention from baseline
Time frame: 12 weeks
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
Time frame: 12 weeks
Change of triglycerides level
The change of triglycerides level at 12 weeks of intervention from baseline
Time frame: 12 weeks
Change of total cholesterol level
The change of total cholesterol level at 12 weeks of intervention from baseline
Time frame: 12 weeks
Change of low density lipoprotein cholesterol (LDL-C) level
The change of LDL-C level at 12 weeks of intervention from baseline
Time frame: 12 weeks
Change of high density lipoprotein cholesterol (HDL-C) level
The change of HDL-C level at 12 weeks of intervention from baseline
Time frame: 12 weeks
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
Time frame: 12 weeks
Change of inflammatory marker levels: interleukin 6 (IL-6) level
The change of IL-6 level at 12 weeks of intervention from baseline
Time frame: 12 weeks
Change of inflammatory marker levels: blood ferritin level
The change of blood ferritin level at 12 weeks of intervention from baseline
Time frame: 12 weeks
Change of total daily calorie intake
The change of total daily calorie intake at 12 weeks of intervention from baseline
Time frame: 12 weeks
Change of body weight/body mass index (BMI)
The change of BMI at 12 weeks of intervention from baseline
Time frame: 12 weeks
Change of body fat and visceral fat percentages
The change of body fat and visceral fat percentages at 12 weeks of intervention from baseline
Time frame: 12 weeks
Change of waist-hip ratio from baseline
The change of waist-hip ratio at 12 weeks of intervention from baseline
Time frame: 12 weeks
Change of blood pressure from baseline
The change of systolic and diastolic blood pressure at 12 weeks of intervention from baseline
Time frame: 12 weeks
Change of heart rate from baseline
The change of heart rate at 12 weeks of intervention from baseline
Time frame: 12 weeks
Plan to share: No
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Sarawak General Hospital