Rosado 2010.

Methods	Design: randomised, double‐blind, placebo‐controlled, parallel group, single‐centre clinical trial Randomisation ratio: not stated
Participants	Participants: 40 participants recruited, 40 analysed (cinnamon = 20, placebo = 20). Mean age (cinnamon = 53.9 ± 9.2 years, placebo = 54.9 ± 10.8 years). Sex (male/female) (cinnamon = 10/10, placebo = 9/11). Duration of diabetes (cinnamon = 5.4 ± 5.9 years, placebo = 4.9 ± 4.8 years) Inclusion criteria: type 2 diabetes mellitus; 30 to 70 years of age; taking metformin for glucose control for at least 3 months (at a daily dose of at least 1000 mg); and FBGL 7.0 to 16.7 mmol/L or HbA1c > 7% Exclusion criteria: pregnancy; known allergy to cinnamon; history of peptic ulceration; BMI > 35 kg/m2; receiving tetracycline therapy; receiving insulin therapy Diagnostic criteria: American Diabetes Association (2003) criteria Co‐morbidities: hyperlipidaemia (70%) Co‐medications: metformin, hypolipidaemic agents, and any other prescribed medications (other than excluded medications)
Interventions	Number of study centres: 1 Country/location: Honolulu, Hawaii, US Setting: medical centre outpatient clinics Intervention (route, total dose/day, frequency): oral, cinnamon 250 mg (water‐soluble extract of C. burmanii; Cinnulin PF®) capsule, twice a day Control (route, total dose/day, frequency): oral, 250 mg bran cereal (control) capsule, twice a day Treatment before study: not stated Titration period: not applicable
Outcomes	Primary outcome(s) (as stated in the publication): not stated Secondary outcomes (as stated in the publication): not stated Additional/other outcomes: HbA1c; FBGL, PPG, total cholesterol; triglycerides; low‐density lipoprotein cholesterol; high‐density lipoprotein cholesterol
Study details	Duration of intervention: 40 days (5.7 weeks) Duration of follow‐up: 20 days Run‐in period: not applicable
Publication details	Language of publication: English Non‐commercial funding Publication status: dissertation
Stated aim of study	To determine whether cinnamon improves blood glucose, triglyceride, total cholesterol, and low‐density lipoprotein cholesterol levels in persons with type‐2 diabetes
Notes	‐
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "randomized"; "subjects were assigned a sequential number..(and)...a sequential number...was assigned to each capsule container based on the computer‐generated (allocation) table...pharmacy personnel randomized the study capsule containers to treatment or control" Comment: probably done
Allocation concealment (selection bias)	Low risk	Quote: "The investigative team did not know the capsule allocation table results"; "The computer‐generated allocation was maintained by...Pharmacy personnel in a sealed envelope" Comment: probably done
Blinding (performance bias and detection bias) All outcomes	Low risk	Quote: "double‐blind"; "(capsulated) cinnamon...for the treatment group and identical capsules...for the control group" Comment: probably done
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	ITT not mentioned, though it appeared that all randomised participants were included in the analysis
Selective reporting (reporting bias)	Unclear risk	All primary outcomes listed were reported, though no study protocol was published or lodged
Other bias	Unclear risk	3 participants withdrew from the study ‐ the reasons for withdrawal differed between groups. Information on enrolments and exclusions was missing