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Effect of Aqueous Cinnamon Extract on the Postprandial Glycaemia Levels in Type 2 Diabetes Mellitus

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Placebo (OGTT)
Cinnamon (OGTT plus aqueous cinnamon extract)
Sponsored by
Egas Moniz - Cooperativa de Ensino Superior, CRL
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes

Eligibility Criteria

35 Years - 77 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • subjects aged 18 years or older
  • subjects with DM2 diagnostic and men or non-pregnant women.

Exclusion Criteria:

  • insulin-treated subjects
  • history of gastrointestinal symptoms/diseases
  • allergy to cinnamon
  • fasting less than 8 hours
  • cinnamon intake at day before the intervention
  • intense exercise until 2 hours before the intervention

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    Placebo (OGTT)

    Cinnamon (OGTT plus aqueous cinnamon extract)

    Arm Description

    The control group was given an glucose solution to oral glucose tolerance test (OGTT) .

    The Experimental group was given an glucose solution to oral glucose tolerance test (OGTT) followed by aqueous cinnamon extract.

    Outcomes

    Primary Outcome Measures

    Blood glucose levels at beginning
    Mean values of blood glucose levels from both control and experimental groups
    Blood glucose levels at 30 minutes
    Mean values of blood glucose levels from both control and experimental groups
    Blood glucose levels at 60 minutes
    Mean values of blood glucose levels from both control and experimental groups
    Blood glucose levels at 90 minutes
    Mean values of blood glucose levels from both control and experimental groups
    Blood glucose levels at 120 minutes
    Mean values of blood glucose levels from both control and experimental groups
    Incremental area under the curve of blood glucose
    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)
    Variation of blood glucose maximum concentration
    Mean values of glucose maximum concentration variation

    Secondary Outcome Measures

    Anthropometric parameters - body weight
    Mean values of body weight (in kilogram - Kg)
    Anthropometric parameters - height
    Mean values of Height (in centimeters - cm)
    Anthropometric parameters - waist circumference
    Mean values of waist circumference (in centimeters - cm)
    Anthropometric parameters - body mass index
    Mean values of body mass index (Kg/m2), calculated as weight (Kg) divided by height (m2) squared (Kg/m2)
    Anthropometric parameters - Skeletal muscle mass
    Mean values of Skeletal muscle mass (in kilogram - Kg)
    Anthropometric parameters - visceral fat
    Mean values of visceral fat (cm3)
    Pharmacological therapy
    Percentage of antidiabetic orals (biguanide, sulfonylurea, alpha-glucosidase inhibitor, dipeptidyl peptidase 4 inhibitors
    Total protein intake
    Means values of total protein intake (in grams - g) obtained through The Food Processor SQL software
    Total lipid intake
    Means values of total lipid intake (in grams - g) obtained through The Food Processor SQL software
    Total carbohydrate intake
    Means values of total carbohydrate intake (in grams - g) obtained through The Food Processor SQL software
    Total energy intake
    Means values of total energy intake (in kilocalorie - Kcal) obtained through The Food Processor SQL software
    Total polyphenols content
    Mean values of total polyphenols content of cinnamon extract (mg/L equivalent of gallic acid)
    Antioxidant activity
    Mean values of antioxidant activity of cinnamon extract by FRAP and DPPH assays (micromol Trolox/L)

    Full Information

    First Posted
    November 10, 2021
    Last Updated
    November 22, 2021
    Sponsor
    Egas Moniz - Cooperativa de Ensino Superior, CRL
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05145673
    Brief Title
    Effect of Aqueous Cinnamon Extract on the Postprandial Glycaemia Levels in Type 2 Diabetes Mellitus
    Official Title
    Effect of Aqueous Cinnamon Extract on the Postprandial Glycaemia Levels in Type 2 Diabetes Mellitus: a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    January 19, 2016 (Actual)
    Primary Completion Date
    October 3, 2016 (Actual)
    Study Completion Date
    October 31, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Egas Moniz - Cooperativa de Ensino Superior, CRL

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type 2 Diabetes

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    36 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo (OGTT)
    Arm Type
    Placebo Comparator
    Arm Description
    The control group was given an glucose solution to oral glucose tolerance test (OGTT) .
    Arm Title
    Cinnamon (OGTT plus aqueous cinnamon extract)
    Arm Type
    Experimental
    Arm Description
    The Experimental group was given an glucose solution to oral glucose tolerance test (OGTT) followed by aqueous cinnamon extract.
    Intervention Type
    Other
    Intervention Name(s)
    Placebo (OGTT)
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Cinnamon (OGTT plus aqueous cinnamon extract)
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Blood glucose levels at beginning
    Description
    Mean values of blood glucose levels from both control and experimental groups
    Time Frame
    At beginning (before intervention)
    Title
    Blood glucose levels at 30 minutes
    Description
    Mean values of blood glucose levels from both control and experimental groups
    Time Frame
    At 30 minutes after intervention
    Title
    Blood glucose levels at 60 minutes
    Description
    Mean values of blood glucose levels from both control and experimental groups
    Time Frame
    At 60 minutes after intervention
    Title
    Blood glucose levels at 90 minutes
    Description
    Mean values of blood glucose levels from both control and experimental groups
    Time Frame
    At 90 minutes after intervention
    Title
    Blood glucose levels at 120 minutes
    Description
    Mean values of blood glucose levels from both control and experimental groups
    Time Frame
    At 120 minutes after intervention
    Title
    Incremental area under the curve of blood glucose
    Description
    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)
    Time Frame
    At 120 minutes after intervention
    Title
    Variation of blood glucose maximum concentration
    Description
    Mean values of glucose maximum concentration variation
    Time Frame
    At 60 minutes after intervention
    Secondary Outcome Measure Information:
    Title
    Anthropometric parameters - body weight
    Description
    Mean values of body weight (in kilogram - Kg)
    Time Frame
    At baseline
    Title
    Anthropometric parameters - height
    Description
    Mean values of Height (in centimeters - cm)
    Time Frame
    At baseline
    Title
    Anthropometric parameters - waist circumference
    Description
    Mean values of waist circumference (in centimeters - cm)
    Time Frame
    At baseline
    Title
    Anthropometric parameters - body mass index
    Description
    Mean values of body mass index (Kg/m2), calculated as weight (Kg) divided by height (m2) squared (Kg/m2)
    Time Frame
    At baseline
    Title
    Anthropometric parameters - Skeletal muscle mass
    Description
    Mean values of Skeletal muscle mass (in kilogram - Kg)
    Time Frame
    At baseline
    Title
    Anthropometric parameters - visceral fat
    Description
    Mean values of visceral fat (cm3)
    Time Frame
    At baseline
    Title
    Pharmacological therapy
    Description
    Percentage of antidiabetic orals (biguanide, sulfonylurea, alpha-glucosidase inhibitor, dipeptidyl peptidase 4 inhibitors
    Time Frame
    At baseline
    Title
    Total protein intake
    Description
    Means values of total protein intake (in grams - g) obtained through The Food Processor SQL software
    Time Frame
    At baseline
    Title
    Total lipid intake
    Description
    Means values of total lipid intake (in grams - g) obtained through The Food Processor SQL software
    Time Frame
    At baseline
    Title
    Total carbohydrate intake
    Description
    Means values of total carbohydrate intake (in grams - g) obtained through The Food Processor SQL software
    Time Frame
    At baseline
    Title
    Total energy intake
    Description
    Means values of total energy intake (in kilocalorie - Kcal) obtained through The Food Processor SQL software
    Time Frame
    At baseline
    Title
    Total polyphenols content
    Description
    Mean values of total polyphenols content of cinnamon extract (mg/L equivalent of gallic acid)
    Time Frame
    At baseline
    Title
    Antioxidant activity
    Description
    Mean values of antioxidant activity of cinnamon extract by FRAP and DPPH assays (micromol Trolox/L)
    Time Frame
    At baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    35 Years
    Maximum Age & Unit of Time
    77 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: subjects aged 18 years or older subjects with DM2 diagnostic and men or non-pregnant women. Exclusion Criteria: insulin-treated subjects history of gastrointestinal symptoms/diseases allergy to cinnamon fasting less than 8 hours cinnamon intake at day before the intervention intense exercise until 2 hours before the intervention

    12. IPD Sharing Statement

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    Effect of Aqueous Cinnamon Extract on the Postprandial Glycaemia Levels in Type 2 Diabetes Mellitus

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