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Recruiting NCT05599633

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

Conditions: Diabetes Mellitus, Type 2

Sex: All
Ages: 18 Years – 70 Years
Phase: NA
Enrollment: 100
Sponsor: Sarawak General Hospital

Location: Malaysia

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.

Eligibility Criteria

Inclusion Criteria:18 - 70 years oldIndividual diagnosed with type 2 diabetes for at least three monthsNot 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 weeksHas HbA1C values of 6.5 - 8.5% within 28 days before commencing the studyAble to complete the clinical study, andAble to provide written informed consentExclusion Criteria:History of allergy to sago starch or corn starchHistory of allergy to any other ingredients in the study foodsClinically significant, active and acute cardiovascular diseaseClinically significant, stage 4 - 5 (estimated glomerular filtration rate <30mL/min/1.73m2), chronic kidney failureClinically significant chronic liver disease or infectionAny malignanciesRegular use of hormone medications, anti-inflammatory medication, steroids, or other medications that might interfere with outcome measureOn a prescribed therapeutic dietTaking part in weight loss programmeClinically significant abnormal laboratory investigationsOther medical conditions or reasons, in the opinion of the Investigator or Research Physician, that make one unsuitable to join the studyConcurrent participation in other clinical studies involving intervention or treatment towards obesity, diabetes or impaired glucosePregnant or lactating mothers

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05599633). StuddyBuddy aggregates publicly available trial information.