AzTrials
AzTrials

Diabetes Mellitus, Type 2SAGODMNCT05599633

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

A study testing Sago starch drink and Corn starch drink in people with Diabetes Mellitus, Type 2, run by Sarawak General Hospital at 4 sites in Malaysia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Sago starch drink and Corn starch drink
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
82 participants
Where
4 sitesMalaysia
Study dates
10 Jan 2022to 20 Jan 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

4 sites in 1 country.

Malaysia4 sites

  • Klinik Kesihatan Batu Kawah

    Kuching, Sarawak, 93250

  • Klinik Kesihatan Jalan Masjid

    Kuching, Sarawak, 93400

  • Klinik Kesihatan Tanah Puteh

    Kuching, Sarawak, 93400

  • Sarawak General Hospital

    Kuching, Sarawak, 93586

Other trials in Malaysia

About this study

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

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.

Read the 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.

Being tested
Sago starch drink, Corn starch drink
Keywords
diabetes mellitus, resistant starch, sago, Sarawak, glycemic control, lipid control
Medical subject headings
Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT05599633
Study groupRoleWhat they receive
Intervention ArmExperimentalSubjects 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.
Receives: Dietary Supplement: Sago starch drink
Control ArmPlacebo comparatorSubjects 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.
Receives: Dietary Supplement: Corn starch drink

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of HbA1C value

    The change of HbA1C value at 12 weeks of intervention from baseline

    Measured: 12 weeks

  2. Change of fasting blood glucose (FBG) level

    The change of FBG level at 12 weeks of intervention from baseline

    Measured: 12 weeks

  3. 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

    Measured: 12 weeks

  4. Change of triglycerides level

    The change of triglycerides level at 12 weeks of intervention from baseline

    Measured: 12 weeks

  5. Change of total cholesterol level

    The change of total cholesterol level at 12 weeks of intervention from baseline

    Measured: 12 weeks

  6. Change of low density lipoprotein cholesterol (LDL-C) level

    The change of LDL-C level at 12 weeks of intervention from baseline

    Measured: 12 weeks

  7. Change of high density lipoprotein cholesterol (HDL-C) level

    The change of HDL-C level at 12 weeks of intervention from baseline

    Measured: 12 weeks

Secondary outcomes (9)

  1. 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

    Measured: 12 weeks

  2. Change of inflammatory marker levels: interleukin 6 (IL-6) level

    The change of IL-6 level at 12 weeks of intervention from baseline

    Measured: 12 weeks

  3. Change of inflammatory marker levels: blood ferritin level

    The change of blood ferritin level at 12 weeks of intervention from baseline

    Measured: 12 weeks

  4. Change of total daily calorie intake

    The change of total daily calorie intake at 12 weeks of intervention from baseline

    Measured: 12 weeks

  5. Change of body weight/body mass index (BMI)

    The change of BMI at 12 weeks of intervention from baseline

    Measured: 12 weeks

  6. Change of body fat and visceral fat percentages

    The change of body fat and visceral fat percentages at 12 weeks of intervention from baseline

    Measured: 12 weeks

  7. Change of waist-hip ratio from baseline

    The change of waist-hip ratio at 12 weeks of intervention from baseline

    Measured: 12 weeks

  8. Change of blood pressure from baseline

    The change of systolic and diastolic blood pressure at 12 weeks of intervention from baseline

    Measured: 12 weeks

  9. Change of heart rate from baseline

    The change of heart rate at 12 weeks of intervention from baseline

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2022
  2. Study start10 Jan 2022
  3. Primary completion19 Jan 2024
  4. Study completion20 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05599633
Sponsor's protocol ID
CRC003-SAGODM
Acronym
SAGODM
Status last verified
Apr 2024
First submitted
26 Oct 2022
Last updated
2 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • King TL, Bugam SH, Khoo SY, Tan SH, Yeo JJP, Tan SSN, Chan PY, Liew NK, Chunggat J, Tiong LL, Ibrahim AS, Tan FHS, Tiong XT. Effects of 12 Weeks consumption of sago starch on glycaemic and lipid control in patients with type 2 diabetes: A double-blind, randomised, parallel controlled trial. Clin Nutr ESPEN. 2025 Aug;68:300-308. doi: 10.1016/j.clnesp.2025.05.002. Epub 2025 May 8.

    PubMed 40345654

Questions about this trial

What is this clinical trial studying?

A study testing Sago starch drink and Corn starch drink in people with Diabetes Mellitus, Type 2, run by Sarawak General Hospital at 4 sites in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of HbA1C value (time frame: 12 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05599633, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in