Effect of Sago-based Product on Glycaemic and Lipid Control in Diabetes

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Dietary Supplement: Sago starch drink
* Dietary Supplement: Corn starch drink


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Arm<br>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<br>* 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.<br>|
| Placebo Comparator: Control Arm<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of HbA1C value | The change of HbA1C value at 12 weeks of intervention from baseline | 12 weeks | 
| Change of fasting blood glucose (FBG) level | The change of FBG level at 12 weeks of intervention from baseline | 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 | 12 weeks | 
| Change of triglycerides level | The change of triglycerides level at 12 weeks of intervention from baseline | 12 weeks | 
| Change of total cholesterol level | The change of total cholesterol level at 12 weeks of intervention from baseline | 12 weeks | 
| Change of low density lipoprotein cholesterol (LDL-C) level | The change of LDL-C level at 12 weeks of intervention from baseline | 12 weeks | 
| Change of high density lipoprotein cholesterol (HDL-C) level | The change of HDL-C level at 12 weeks of intervention from baseline | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 12 weeks | 
| Change of inflammatory marker levels: blood ferritin level | The change of blood ferritin level at 12 weeks of intervention from baseline | 12 weeks | 
| Change of total daily calorie intake | The change of total daily calorie intake at 12 weeks of intervention from baseline | 12 weeks | 
| Change of body weight/body mass index (BMI) | The change of BMI at 12 weeks of intervention from baseline | 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 | 12 weeks | 
| Change of waist-hip ratio from baseline | The change of waist-hip ratio at 12 weeks of intervention from baseline | 12 weeks | 
| Change of blood pressure from baseline | The change of systolic and diastolic blood pressure at 12 weeks of intervention from baseline | 12 weeks | 
| Change of heart rate from baseline | The change of heart rate at 12 weeks of intervention from baseline | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes mellitus, resistant starch, sago, Sarawak, glycemic control, lipid control