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

About this trial
This is an interventional treatment trial for Type 2 Diabetes
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
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
NCT ID
NCT05145673
First Posted
November 10, 2021
Last Updated
November 22, 2021
Sponsor
Egas Moniz - Cooperativa de Ensino Superior, CRL
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
Learn more about this trial
Effect of Aqueous Cinnamon Extract on the Postprandial Glycaemia Levels in Type 2 Diabetes Mellitus
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