NCT05599633

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Sarawak General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Sago 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.
DIETARY_SUPPLEMENT	Corn starch drink	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.

Timeline

• Start date: 2022-01-10
• Primary completion: 2024-01-19
• Completion: 2024-01-20
• First posted: 2022-10-31
• Last updated: 2024-12-02

Locations

4 sites across 1 country: Malaysia