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

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Dietary Supplement: Corn starch drink; Dietary Supplement: Sago starch drink

• Registration Number: NCT05599633
• Lead Sponsor: Sarawak General Hospital

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.

Study Timeline

• Study Start: 2022-01-10
• Study First Submitted: 2022-10-26
• Study First Submitted QC: 2022-10-26
• Study First Posted: 2022-10-31
• Primary Completion: 2024-01-19
• Study Completion: 2024-01-20
• Status Verified: 2024-04
• Last Update Submitted: 2024-11-27
• Last Update Posted: 2024-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

1. 18 - 70 years old
2. Individual diagnosed with type 2 diabetes for at least three months
3. 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
4. Has HbA1C values of 6.5 - 8.5% within 28 days before commencing the study
5. Able to complete the clinical study, and
6. Able to provide written informed consent

Exclusion Criteria

1. History of allergy to sago starch or corn starch
2. History of allergy to any other ingredients in the study foods
3. Clinically significant, active and acute cardiovascular disease
4. Clinically significant, stage 4 - 5 (estimated glomerular filtration rate <30mL/min/1.73m2), chronic kidney failure
5. Clinically significant chronic liver disease or infection
6. Any malignancies
7. Regular use of hormone medications, anti-inflammatory medication, steroids, or other medications that might interfere with outcome measure
8. On a prescribed therapeutic diet
9. Taking part in weight loss programme
10. Clinically significant abnormal laboratory investigations
11. Other medical conditions or reasons, in the opinion of the Investigator or Research Physician, that make one unsuitable to join the study
12. Concurrent participation in other clinical studies involving intervention or treatment towards obesity, diabetes or impaired glucose
13. Pregnant or lactating mothers

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Arm	Corn 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.
Intervention Arm	Sago starch drink	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.

Primary Outcome Measures

Name	Time	Method
Change of HbA1C value	12 weeks	The change of HbA1C value at 12 weeks of intervention from baseline
Change of fasting blood glucose (FBG) level	12 weeks	The change of FBG level at 12 weeks of intervention from baseline
Change of homeostasis model assessment (HOMA) of insulin resistance (HOMA-IR) value	12 weeks	The change of HOMA of insulin resistant value at 12 weeks of intervention from baseline
Change of high density lipoprotein cholesterol (HDL-C) level	12 weeks	The change of HDL-C level at 12 weeks of intervention from baseline
Change of triglycerides level	12 weeks	The change of triglycerides level at 12 weeks of intervention from baseline
Change of total cholesterol level	12 weeks	The change of total cholesterol level at 12 weeks of intervention from baseline
Change of low density lipoprotein cholesterol (LDL-C) level	12 weeks	The change of LDL-C level at 12 weeks of intervention from baseline

Secondary Outcome Measures

Name	Time	Method
Change of total daily calorie intake	12 weeks	The change of total daily calorie intake at 12 weeks of intervention from baseline
Change of body fat and visceral fat percentages	12 weeks	The change of body fat and visceral fat percentages at 12 weeks of intervention from baseline
Change of waist-hip ratio from baseline	12 weeks	The change of waist-hip ratio at 12 weeks of intervention from baseline
Change of blood pressure from baseline	12 weeks	The change of systolic and diastolic blood pressure at 12 weeks of intervention from baseline
Change of inflammatory marker levels: high-sensitive c-reactive protein (hs-CRP) level	12 weeks	The change of hs-CRP level at 12 weeks of intervention from baseline
Change of inflammatory marker levels: interleukin 6 (IL-6) level	12 weeks	The change of IL-6 level at 12 weeks of intervention from baseline
Change of inflammatory marker levels: blood ferritin level	12 weeks	The change of blood ferritin level at 12 weeks of intervention from baseline
Change of body weight/body mass index (BMI)	12 weeks	The change of BMI at 12 weeks of intervention from baseline
Change of heart rate from baseline	12 weeks	The change of heart rate at 12 weeks of intervention from baseline

Trial Locations

Locations (4)

Klinik Kesihatan Batu Kawah; 🇲🇾 Kuching, Sarawak, Malaysia

Klinik Kesihatan Jalan Masjid; 🇲🇾 Kuching, Sarawak, Malaysia

Klinik Kesihatan Tanah Puteh; 🇲🇾 Kuching, Sarawak, Malaysia

Sarawak General Hospital; 🇲🇾 Kuching, Sarawak, Malaysia