Is There a Metabolic Effect of Cinnamon on HbA1c, Blood Pressure and Serum Lipids in Type 2 Diabetes Mellitus?
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the study is to assess whether dietary supplementation of cinnamon (cinnamon
      cassia) has the potential to improve HbA1c, blood pressure and serum lipid measurements in
      patients with type 2 diabetes mellitus.
    

Detailed description: 
      The study will be conducted for 3 months (12 weeks) with 58 individuals diagnosed with type 2
      diabetes mellitus. The randomisation will be carried out by using a randomisation list.
      Cinnamon bark (cinnamon cassia) and starch flour (placebo) capsules will be purchased from a
      local pharmaceutical company in UK; these are freely available for over the counter use. Each
      capsule contained either 500 mg of cinnamon powder or starch flour. The cinnamon and placebo
      (starch flour) capsules will be packaged in a non transparent plastic bags.

      The patients will be randomly allocated into the two groups of:

      Group 1: placebo control group Group 2: cinnamon group

      Patients in both placebo and cinnamon groups will receive treatment similar to the treatment
      they would normally receive from their respective NHS or primary care trust for 12 weeks.

      Data collection:

      After the randomisation the subjects will be scheduled to visit the clinic at 0 weeks, 6 - 7
      weeks and 12 weeks from the beginning of the study. During every visit (week 0, weeks 6 - 7
      and week 12) a 3-day diet diary will be collected and the intake of total calories, fats,
      carbohydrates, proteins and fibre will be determined. Compliance with the diet will be
      monitored by individual discussions at each clinical visit with dietician and compared with
      the diet diary. The anthropometric measurements of body weight, height, waist and hip
      circumferences will be measured before the trial (week 0), during the trial (weeks 6 - 7) and
      after the trial (week 12) period. The recorded clinical measurements of blood profiles
      include HbA1c level, fasting plasma glucose concentration and serum lipid profiles including
      serum total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL) and
      serum triglycerides, systolic and diastolic blood pressures will be measured at the baseline
      (week 0) and at 12 weeks during the study period.
    

Intervention name(s): cinnamon 2g per day for 12 weeks
Intervention type(s): Dietary Supplement
Intervention description(s): Subjects in intervention group will receive cinnamon capsules for 12 weeks period. The 2 g dose of cinnamon will be spread over the day as 500 mg (1 capsule) after breakfast, 1000 mg (2 capsules) after lunch and 500 mg (1 capsule) after dinner. The subjects will be instructed to take the capsules immediately after the meals.
Other intervention name(s): cinnamon
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: blood sugar; cholesterol; cinnamon; HbA1c