Clinical trial NCT05599633: Effect of Sago-based Product on Glycaemic and Lipid Control in Diabetes
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: diabetes mellitus
resistant starch
sago
Sarawak
glycemic control
lipid control
Lead sponsor: Sarawak General Hospital
Sponsor class: OTHER
Collaborators: name: CRAUN Research Sdn. Bhd.
First posted: 2022-10-31
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of HbA1C value
timeFrame: 12 weeks
measure: Change of fasting blood glucose (FBG) level
timeFrame: 12 weeks
measure: Change of homeostasis model assessment (HOMA) of insulin resistance (HOMA-IR) value
timeFrame: 12 weeks
measure: Change of triglycerides level
timeFrame: 12 weeks
measure: Change of total cholesterol level
timeFrame: 12 weeks
measure: Change of low density lipoprotein cholesterol (LDL-C) level
timeFrame: 12 weeks
measure: Change of high density lipoprotein cholesterol (HDL-C) level
timeFrame: 12 weeks
Secondary outcomes:
measure: Change of inflammatory marker levels: high-sensitive c-reactive protein (hs-CRP) level
timeFrame: 12 weeks
measure: Change of inflammatory marker levels: interleukin 6 (IL-6) level
timeFrame: 12 weeks
measure: Change of inflammatory marker levels: blood ferritin level
timeFrame: 12 weeks
measure: Change of total daily calorie intake
timeFrame: 12 weeks
measure: Change of body weight/body mass index (BMI)
timeFrame: 12 weeks
measure: Change of body fat and visceral fat percentages
timeFrame: 12 weeks
measure: Change of waist-hip ratio from baseline
timeFrame: 12 weeks
measure: Change of blood pressure from baseline
timeFrame: 12 weeks
measure: Change of heart rate from baseline
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Kuching
country: Malaysia
facility: Klinik Kesihatan Batu Kawah
state: Sarawak
city: Kuching
country: Malaysia
facility: Klinik Kesihatan Jalan Masjid
state: Sarawak
city: Kuching
country: Malaysia
facility: Klinik Kesihatan Tanah Puteh
state: Sarawak
city: Kuching
country: Malaysia
facility: Sarawak General Hospital
state: Sarawak
Study officials:
affiliation: Clinical Research Centre Sarawak General Hospital
name: Xun Ting Tiong
role: PRINCIPAL_INVESTIGATOR
References: