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

NCT05599633 | Completed

• 1 other identifier: CRC003-SAGODM
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Diabetes Mellitus, Type 2

Keywords

diabetes mellitus; resistant starch; sago; Sarawak; glycemic control; lipid control

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (9)

• Change of inflammatory marker levels: high-sensitive c-reactive protein (hs-CRP) level

  12 weeks

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

  12 weeks

• Change of inflammatory marker levels: blood ferritin level

  12 weeks

• Change of total daily calorie intake

  12 weeks

• Change of body weight/body mass index (BMI)

  12 weeks

Study Arms (2)

Intervention Arm

EXPERIMENTAL

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

Control Arm

PLACEBO COMPARATOR

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

Interventions

Sago starch drink DIETARY_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.

Intervention Arm

Corn starch drink DIETARY_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.

Control Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Sarawak General Hospital: lead
• CRAUN Research Sdn. Bhd.: collaborator

Study Sites (4)

Klinik Kesihatan Batu Kawah

Kuching, Sarawak, 93250, Malaysia

Location

Klinik Kesihatan Jalan Masjid

Kuching, Sarawak, 93400, Malaysia

Location

Klinik Kesihatan Tanah Puteh

Kuching, Sarawak, 93400, Malaysia

Location

Sarawak General Hospital

Kuching, Sarawak, 93586, Malaysia

Location

Related Publications (1)

• 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.

  PMID: 40345654 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Xun Ting Tiong

  Clinical Research Centre Sarawak General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Intervention (Sago starch) and control (corn starch) will be packed in individual aluminium sachets and will not be distinguishable from each other. The included subjects and investigators will be blinded from the study arm assignment. Randomisation and dispensation of the study starch will be done by the unblinded pharmacists only, who will not be involved in the care of the patients and study endpoint assessments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Officer

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: October 31, 2022
• Study Start: January 10, 2022
• Primary Completion: January 19, 2024
• Study Completion: January 20, 2024
• Last Updated: December 2, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

MY (4)