NCT02322268

RCT Evaluating Effects of Cosmos Caudatus (Ulam Raja) in T2DM Patients

Metabolomic Profiling on The Effect of Cosmos Caudatus (Ulam Raja) Supplementation in Patients With Type 2 Diabetes: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Universiti Putra Malaysia · Academic / Other
• Sex: All
• Age: 30 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether Cosmos caudatus is effective as an adjuvant therapy for type 2 Diabetes Mellitus.

Detailed description

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.

Conditions

• Type 2 Diabetes Mellitus
• Obesity

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Cosmos Caudatus	15g of Cosmos caudatus consumed with lunch or dinner

Timeline

• Start date: 2014-08-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2014-12-23
• Last updated: 2015-12-02

Locations

1 site across 1 country: Malaysia