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

Sarawak General Hospital82 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Diabetes Mellitus, Type 2

Interventions

Sago starch drinkDIETARY_SUPPLEMENT

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 drinkDIETARY_SUPPLEMENT

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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