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

Diabetes Mellitus, Type 2 Clinical Trial

— SAGODM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05599633
• Other study ID #: CRC003-SAGODM
• Status: Recruiting
• Phase: N/A
• Start date: January 10, 2022
• Est. completion date: June 2023

Study information

• Verified date: January 2023
• Source: Sarawak General Hospital
• Contact: Teck Long King
• Phone: 60168911615
• Email: kingtl[@]crc.moh.gov.my
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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.
• 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.

Locations

Country	Name	City	State
Malaysia	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

Sponsors (2)

Lead Sponsor	Collaborator
Sarawak General Hospital	CRAUN Research Sdn. Bhd.

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of HbA1C value	The change of HbA1C value at 12 weeks of intervention from baseline	12 weeks
Primary	Change of fasting blood glucose (FBG) level	The change of FBG level at 12 weeks of intervention from baseline	12 weeks
Primary	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
Primary	Change of triglycerides level	The change of triglycerides level at 12 weeks of intervention from baseline	12 weeks
Primary	Change of total cholesterol level	The change of total cholesterol level at 12 weeks of intervention from baseline	12 weeks
Primary	Change of low density lipoprotein cholesterol (LDL-C) level	The change of LDL-C level at 12 weeks of intervention from baseline	12 weeks
Primary	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	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
Secondary	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
Secondary	Change of inflammatory marker levels: blood ferritin level	The change of blood ferritin level at 12 weeks of intervention from baseline	12 weeks
Secondary	Change of total daily calorie intake	The change of total daily calorie intake at 12 weeks of intervention from baseline	12 weeks
Secondary	Change of body weight/body mass index (BMI)	The change of BMI at 12 weeks of intervention from baseline	12 weeks
Secondary	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
Secondary	Change of waist-hip ratio from baseline	The change of waist-hip ratio at 12 weeks of intervention from baseline	12 weeks
Secondary	Change of blood pressure from baseline	The change of systolic and diastolic blood pressure at 12 weeks of intervention from baseline	12 weeks
Secondary	Change of heart rate from baseline	The change of heart rate at 12 weeks of intervention from baseline	12 weeks