NCT05599633Completed
Effect of Sago-based Product on Glycaemic and Lipid Control in Diabetes
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
Source: ClinicalTrials.gov · Last updated 2 Dec 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 82 (actual)
- First submitted
- 26 Oct 2022
- Start date
- 10 Jan 2022
- Primary completion date
- 19 Jan 2024
- Lead sponsor
- Sarawak General Hospital
- Diseases
- Type 2 diabetes
- NCT number
- NCT05599633
What you commit to
- Study type: Interventional
- Participants enrolled: 82
- From 10 Jan 2022 to the primary completion date, 19 Jan 2024
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Regular use of hormone medications, anti-inflammatory medication, steroids, or other medications that might interfere with outcome measure
Other illness
- 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
- Other medical conditions or reasons, in the opinion of the Investigator or Research Physician, that make one unsuitable to join the study
Lab values
- Clinically significant abnormal laboratory investigations
- Concurrent participation in other clinical studies involving intervention or treatment towards obesity, diabetes or impaired glucose
Other
- On a prescribed therapeutic diet
- Taking part in weight loss programme
- Pregnant or lactating mothers
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sarawak General Hospital Coordinator of this site? Confirm its status | Kuching | Malaysia | Unknown status |
| Klinik Kesihatan Jalan Masjid Coordinator of this site? Confirm its status | Kuching | Malaysia | Unknown status |
| Klinik Kesihatan Tanah Puteh Coordinator of this site? Confirm its status | Kuching | Malaysia | Unknown status |
| Klinik Kesihatan Batu Kawah Coordinator of this site? Confirm its status | Kuching | Malaysia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.