Vanschoonbeek 2006.
| Methods | Design: double‐blind, placebo‐controlled, parallel group, single‐centre clinical trial Randomisation ratio: not stated |
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| Participants | Participants: 25 postmenopausal woman recruited, 25 analysed (cinnamon = 12, placebo = 13). Mean age (cinnamon = 62 ± 2 years, placebo = 64 ± 2 years). Duration of diabetes (cinnamon = 7.6 ± 1.4 years, placebo = 7.1 ± 1.6 years) Inclusion criteria: type 2 diabetes mellitus Exclusion criteria: impaired liver or renal function; cardiovascular disease; exogenous insulin therapy Diagnostic criteria: WHO (1999) criteria Co‐morbidities: not stated Co‐medications: oral hypoglycaemic agents (metformin, sulphonylureas, thiazolidinediones) | |
| Interventions | Number of study centres: 1 Country/location: Maastricht, Netherlands Setting: university research laboratory Intervention (route, total dose/day, frequency): oral, cinnamon 500 mg (C. cassia) capsule, 3 times a day Control (route, total dose/day, frequency): oral, 1 wheat flour capsule, 3 times a day Treatment before study: not applicable 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; fasting plasma insulin; OGIS; ISIcomp; HOMA‐IR; total cholesterol; low‐density lipoprotein cholesterol; high‐density lipoprotein cholesterol; triacylglycerol | |
| Study details | Duration of intervention: 6 weeks Duration of follow‐up: not applicable Run‐in period: not applicable | |
| Publication details | Language of publication: English (Non‐)/commercial funding: not stated Publication status: peer‐reviewed journal |
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| Stated aim of study | To determine the effects of cinnamon supplementation on FBGL, insulin, HbA1c, whole‐body insulin sensitivity, and serum lipids | |
| Notes | ‐ | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Method of treatment allocation not mentioned Comment: probably not done |
| Allocation concealment (selection bias) | Unclear risk | Method of allocation concealment not described Comment: probably not done |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Quote: "double‐blind"; "capsules...could not be distinguished by color, scent, or taste" 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 | Information on enrolments, exclusions and withdrawals was missing |
BMI: body mass index; FBGL: fasting blood glucose level; HbA1c: glycosylated haemoglobin; HMG‐CoA: 3‐hydroxy‐3‐methyl‐glutaryl‐CoA; HOMA‐IR: homeostasis model assessment of insulin resistance; ISIcomp: index of composite whole‐body insulin sensitivity; ITT: intention to treat; OGIS: oral glucose insulin sensitivity; PPG: postprandial glucose.