title: Effect of Cosmos caudatus (Ulam raja) supplementation in patients with type 2 diabetes: Study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Type 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
  This 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.
  
  
  CONCLUSIONS
  The 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.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier: NCT02322268.
authors.affiliation: Department of Nutrition and Dietetics, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, 43400, Serdang, Selangor, Malaysia. shihui0731@gmail.com.
authors.forename: Shi-Hui
authors.initials: SH
authors.lastname: Cheng
authors.affiliation: 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, Serdang, 43300, Selangor, Malaysia.
authors.forename: Amin
authors.initials: A
authors.lastname: Ismail
authors.affiliation: Department of Medicine, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, 43300, Selangor, Malaysia.
authors.forename: Joseph
authors.initials: J
authors.lastname: Anthony
authors.affiliation: Department of Medicine, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, 43300, Selangor, Malaysia.
authors.forename: Ooi Chuan
authors.initials: OC
authors.lastname: Ng
authors.affiliation: Department of Food Science, Faculty of Food Science and Technology, Universiti Putra Malaysia, Serdang, 43300, Selangor, Malaysia.
authors.forename: Azizah Abdul
authors.initials: AA
authors.lastname: Hamid
authors.affiliation: Department of Nutrition and Dietetics, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, 43400, Serdang, Selangor, Malaysia. bnisak@upm.edu.my.|Research Centre of Excellent for Nutrition and Non-communicable Diseases, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, 43300, Selangor, Malaysia. bnisak@upm.edu.my.
authors.forename: Barakatun-Nisak Mohd
authors.initials: BN
authors.lastname: Yusof
mesh_terms: D000328:Adult; D000368:Aged; D019659:Asteraceae; D001786:Blood Glucose / Q000378:metabolism*; D002985:Clinical Protocols; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy* / Q000378:metabolism; D019587:Dietary Supplements; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000494:pharmacology / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D008517:Phytotherapy; D010936:Plant Extracts / Q000494:pharmacology / Q000627:therapeutic use*; D012107:Research Design
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents; D010936:Plant Extracts