Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:58 AM
Ignite Modification Date:
2025-12-25 @ 2:58 AM
NCT ID:
NCT05599633
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05599633
Study Brief:
Protocol Section:
NCT05599633