RCT Evaluating Effects of Cosmos Caudatus (Ulam Raja) in T2DM Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02322268|
Recruitment Status : Completed
First Posted : December 23, 2014
Last Update Posted : December 2, 2015
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus Obesity||Dietary Supplement: Cosmos Caudatus||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||101 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Metabolomic Profiling on The Effect of Cosmos Caudatus (Ulam Raja) Supplementation in Patients With Type 2 Diabetes: A Randomized Controlled Trial|
|Study Start Date :||August 2014|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||November 2015|
Experimental: Diabetic Cosmos caudatus treated group
Subjects in this arm will receive Cosmos caudatus for 8 weeks.
Dietary Supplement: Cosmos Caudatus
15g of Cosmos caudatus consumed with lunch or dinner
Other Name: Ulam Raja
No Intervention: Diabetic control group
Subject in this group will not receive Cosmos caudatus. However, they will be educated for the same calorie intake and lifestyle intervention as in Cosmos caudatus treated group.
- Glycemic control [ Time Frame: 1 month ]
- Liver profile [ Time Frame: 1 month ]
- Renal profile [ Time Frame: 1 month ]
- Blood pressure [ Time Frame: 1 month ]
- Metabolite profile [ Time Frame: 1 month ]
- Inflammatory marker [ Time Frame: 1 month ]
- Lipid profile [ Time Frame: 1 month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02322268
|Serdang, Selangor, Malaysia, 43400|
|Principal Investigator:||Shi Hui Cheng||Universiti Putra Malaysia|