Effect of Cosmos caudatus (Ulam raja) supplementation in patients with type 2 diabetes: Study protocol for a randomized controlled trial

BMC Complementary and Alternative Medicine

Study Protocol

Azizah Abdul Hamid¹  Joseph Anthony²  Ooi Chuan Ng²  Shi-Hui Cheng³  Amin Ismail⁴  Barakatun-Nisak Mohd Yusof⁴ 

[1] Department of Food Science, Faculty of Food Science and Technology, Universiti Putra Malaysia, 43300, Serdang, Selangor, Malaysia;Department of Medicine, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, 43300, Serdang, Selangor, Malaysia;Department of Nutrition and Dietetics, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, 43400, Serdang, Selangor, Malaysia;Department of Nutrition and Dietetics, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, 43400, Serdang, Selangor, Malaysia;Research Centre of Excellent for Nutrition and Non-communicable Diseases, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, 43300, Serdang, Selangor, Malaysia;

关键词: Cosmos caudatus;    Type 2 diabetes mellitus;    Glycemic status;    Metabolomic;    Herbal medicine;    Functional food;    Dietary Supplementation;    Randomized controlled trial;   

DOI  :  10.1186/s12906-016-1047-7

 received in 2015-11-05, accepted in 2016-02-12,  发布年份 2016

来源: Springer

【 摘 要 】

BackgroundType 2 diabetes mellitus is a major health threat worldwide. Cosmos caudatus is one of the medicinal plants used to treat type 2 diabetes. Therefore, this study aims to determine the effectiveness and safety of C. caudatus in patients with type 2 diabetes. Metabolomic approach will be carried out to compare the metabolite profiles between C. Caudatus treated diabetic patients and diabetic controls.Methods and designThis is a single-center, randomized, controlled, two-arm parallel design clinical trial that will be carried out in a tertiary hospital in Malaysia. In this study, 100 patients diagnosed with type 2 diabetes will be enrolled. Diabetic patients who meet the eligibility criteria will be randomly allocated to two groups, which are diabetic C. caudatus treated(U) group and diabetic control (C) group. Primary and secondary outcomes will be measured at baseline, 4, 8, and 12 weeks. The serum and urine metabolome of both groups will be examined using proton NMR spectroscopy.DiscussionThe study will be the first randomized controlled trial to assess whether C. caudatus can confer beneficial effect in patients with type 2 diabetes. The results of this trial will provide clinical evidence on the effectiveness and safety of C. caudatus in patients with type 2 diabetes.Trial registrationClinicalTrials.gov identifier: NCT02322268

【 授权许可】

CC BY   
© Cheng et al. 2016