Effect of Aqueous Cinnamon Extract on the Postprandial Glycaemia Levels in Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The type 2 diabetes mellitus is a chronic disease and it is a highly prevalent globally.
      Cinnamon is a spicy used on the traditional cuisine, which have as been associated with
      beneficial effects on postprandial blood glucose levels (BGL). The aim of the present study
      was to investigate the effect of cinnamon tea (6g C. burmannii/100mL) on postprandial
      glycaemia in type 2 diabetic adults.

      Following ethical committee approval, thirty-six subjects were selected and randomly
      allocated in 2 groups (n=18): cinnamon group, which was administrated OGTT (oral glucose
      tolerance test) followed by cinnamon tea; control group, which was administrated only OGTT.
      At baseline, anthropometric data, medical condition and pharmacological therapy were
      collected. A 24-hour dietary recall was taken preceding each intervention. Food Processor SQL
      (version 10.5.9) program was used to analyze the food nutritional composition. Chemical
      analysis was performed for total phenols determinations (adapted from Prabha et al) and
      antioxidant activity for FRAP and for DPPH tests (adapted from K. Thaipong et al.)
      Statistical analysis was performed using SPSS Statistics program. Data are mean±SEM.
    

Detailed description: 
      Type 2 diabetes mellitus (DM2) subjects aged between 35-77 years were recruited into this
      study through nutrition appointment, Holon Pharmacy from Lisbon and Portalegre, Portugal.
      After the approval of the Ethics Committee, 36 individuals, were selected and invited to
      participate in this study. After eligibility criteria applied, a randomized controlled
      clinical trial, blind to participants, was conducted to 36 DM2 subjects. Participants were
      randomly assigned to intervention (n=18) or control group (n=18). The first participant of
      the study was randomly allocated to intervention or control group and the following
      participants were systematically allocated in each group. The anonymity and the
      confidentiality of the participants data collected were guaranteed through a code attributed
      to each participant. The control group was given a glucose solution to oral glucose tolerance
      test (OGTT) and the intervention group was given a glucose solution to OGTT followed by a
      cinnamon aqueous extract. The glucose solution consist in a glucose drink with 75g of
      anhydrous D-Glucose dissolved in 200 mL of water at room temperature, as prescribed by ADA.
      The blood glucose levels were measured before intervention at fasting (t0) and after 30
      (t30), 60 (t60, 90 (t90) and 120 (t120) minutes after intervention from both groups.

      Aqueous cinnamon extract was prepared by Cinnamomum burmannii bark (from Sucrame Company,
      Portugal) with Indonesia origin. Sticks of cinnamon (60 g) were soaked into 1000 mL of water.
      After 24 h at room temperature, cinnamon solution was heated for 30 min at 100°C and then
      filtered at room temperature. After the cinnamon tea preparation a 100 mL individual dose was
      distributed to each participant. For chemical analysis, a hydromethanolic extract (50 : 50)
      was performed with aqueous cinnamon extract previously obtained.

      Anthropometric paraments and pharmacological therapy data were collected at the beginning of
      the study. At day before the intervention, a 24-hour food recall questionnaire was employed
      to participants of the study and carefully instructed by an investigator to complete the food
      record. The Food Processor SQL (10.14.2. version) programme was applied to analysed the
      nutritional composition of meals, such as, total energy intake (Kcal), proteins (g), lipids
      (g), carbohydrates (g), dietary fibre (g) and soluble fibre (g). It were also estimated the
      glycemic index and glycemic load of food intake.

      Based on the blood glucose values, the blood glucose incremental area under the curve (AUCi)
      of each participant was defined using the GraphPad Prism program (version 5.0). Maximum
      concentrations (Cmax) and variations of maximum concentrations (ΔCmax) were determined by
      comparing with its respective baseline glycemia levels values.

      The total phenolic concentration in the C. burmanni extract was determined according to
      Folin-Ciocalteu method employing gallic acid as standard. For the determination of
      antioxidant activity two methods were performed: FRAP and DPPH, adapted by Thaipong et al.
      The FRAP method for determination of ferric reducing effect was based on the reduction, at
      low pH, employing a colourless ferric complex (Fe3+) to a blue-coloured ferrous complex
      (Fe2+) by electron-donating antioxidants action in 2,4,6-tri(2-pyridyl)-s-triazine (TPTZ)
      presence.
    

Intervention name(s): Placebo (OGTT); Cinnamon (OGTT plus aqueous cinnamon extract)
Intervention type(s): Other; Other
Intervention description(s): The control group was given an glucose solution to oral glucose tolerance test (OGTT) The glucose solution consist in a glucose drink with 75g of anhydrous D-Glucose dissolved in 200 mL of water at room temperature, as prescribed by ADA. The blood glucose levels were measured before intervention at fasting (t0) and after 30 (t30), 60 (t60, 90 (t90) and 120 (t120) minutes after intervention from both groups.; The intervention group was given an glucose solution to OGTT followed by a cinnamon aqueous extract. The glucose solution consist in a glucose drink with 75g of anhydrous D-Glucose dissolved in 200 mL of water at room temperature, as prescribed by ADA. The blood glucose levels were measured before intervention at fasting (t0) and after 30 (t30), 60 (t60, 90 (t90) and 120 (t120) minutes after intervention from both groups.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment