Loading clinical trials...
Loading clinical trials...
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.
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.
Age
18 - 70 years
Sex
ALL
Healthy Volunteers
No
Klinik Kesihatan Batu Kawah
Kuching, Sarawak, Malaysia
Klinik Kesihatan Jalan Masjid
Kuching, Sarawak, Malaysia
Klinik Kesihatan Tanah Puteh
Kuching, Sarawak, Malaysia
Sarawak General Hospital
Kuching, Sarawak, Malaysia
Start Date
January 10, 2022
Primary Completion Date
January 19, 2024
Completion Date
January 20, 2024
Last Updated
December 2, 2024
82
ACTUAL participants
Sago starch drink
DIETARY_SUPPLEMENT
Corn starch drink
DIETARY_SUPPLEMENT
Lead Sponsor
Sarawak General Hospital
Collaborators
NCT06959901
NCT06574035
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06861062