Obesity Clinical Trial
Official title:
Metabolomic Profiling on The Effect of Cosmos Caudatus (Ulam Raja) Supplementation in Patients With Type 2 Diabetes: A Randomized Controlled Trial
The purpose of this study is to determine whether Cosmos caudatus is effective as an adjuvant therapy for type 2 Diabetes Mellitus.
Background: Cosmos caudatus (C. caudatus) ethanol extract has been reported to have
extraordinary high antioxidant capacity compared to other plants. Furthermore it has been
shown to reduce the plasma blood glucose and lipid profile significantly in an animal model.
However, no study has been reported on its effectiveness in human. Therefore, we plan to
conduct a randomized controlled trial to evaluate the effectiveness and safety of C.
caudatus on glycemic status, oxidative stress markers, inflammatory markers, lipid profile
in patients with type 2 diabetes. Besides, metabolomics approach will be carried out to
compare the metabolite changes between diabetic C. caudatus treated and control patients.
Methods: A single-center randomized, controlled, two-arm parallel design clinical trial will
be carried out in Malaysia. This study enrol 92 patients diagnosed with type 2 diabetes.
Diabetic patients who meet eligibility criteria will be randomly allocated to two groups,
which are C. caudatus treatment group and control group. Both groups will be compared on the
primary and secondary outcomes at baseline, 4, 8, and 12 weeks. The serum and urine
metabolome of both groups will be examined using proton NMR spectroscopy.
Discussion: The study will provide insights into the potential beneficial effect of C.
caudatus in type 2 diabetic patients. In addition, the therapeutic effect of C. caudatus
towards type 2 diabetes will reflect as a change of metabolite profile in urine and serum.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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