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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Dietary supplement: Sago starch drink; Dietary supplement: Corn starch drink

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Teck Long King; Phone Number: 60168911615; Email: kingtl@crc.moh.gov.my

Study Locations

• Malaysia
  • Sarawak
    • Kuching, Sarawak, Malaysia, 93586
      • Recruiting
      • Sarawak General Hospital
      • Contact: Director; Phone Number: 1011 6082276666; Email: sgh@moh.gov.my
      • Sub-Investigator: Teck Long King
      • Sub-Investigator: Florence Hui Sieng Tan
      • Sub-Investigator: Leh Siang Yeo
      • Sub-Investigator: Jawing Chunggat
      • Sub-Investigator: Pei Yong Chan
      • Sub-Investigator: Sing Yee Khoo
      • Sub-Investigator: John Yeo
      • Sub-Investigator: Ngan Kai Liew
      • Principal Investigator: Xun Ting Tiong
    • Kuching, Sarawak, Malaysia, 93250
      • Recruiting
      • Klinik Kesihatan Batu Kawah
      • Contact: Azreen Abdullah; Phone Number: 6082688518
      • Principal Investigator: Azreen Abdullah
    • Kuching, Sarawak, Malaysia, 93400
      • Recruiting
      • Klinik Kesihatan Jalan Masjid
      • Contact: Maila Mustapha; Phone Number: 6082427110
      • Principal Investigator: Maila Mustapha
    • Kuching, Sarawak, Malaysia, 93400
      • Recruiting
      • Klinik Kesihatan Tanah Puteh
      • Contact: Muhamad Irfan Yasin Ali Uddin; Phone Number: 6082344011
      • Principal Investigator: Muhamad Irfan Yasin Ali Uddin
      • Principal Investigator: Peter Jerampang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Arm; 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; 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 addition of 3g of white cocoa extract as flavouring and 0.2g xanthan gum as the stabiliser.
Placebo Comparator: Control Arm; 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; 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 addition of 3g of white cocoa extract as flavouring and 0.2g xanthan gum as the stabiliser.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sarawak General Hospital
• Collaborators: CRAUN Research Sdn. Bhd.
• Investigators: Principal Investigator: Xun Ting Tiong, Clinical Research Centre Sarawak General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2022
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: October 26, 2022
• First Submitted That Met QC Criteria: October 26, 2022
• First Posted (Actual): October 31, 2022

Study Record Updates

• Last Update Posted (Actual): October 31, 2022
• Last Update Submitted That Met QC Criteria: October 26, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: diabetes mellitus; glycemic control; resistant starch; sago; Sarawak; lipid control
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: CRC003-SAGODM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No