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

Type 2 Diabetes Clinical Trial

Official title:

Effect of Aqueous Cinnamon Extract on the Postprandial Glycaemia Levels in Type 2 Diabetes Mellitus: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05145673
• Other study ID #: 525cinnamon
• Status: Completed
• Phase: N/A
• Start date: January 19, 2016
• Est. completion date: October 31, 2016

Study information

• Verified date: November 2021
• Source: Egas Moniz - Cooperativa de Ensino Superior, CRL
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: October 31, 2016
• Est. primary completion date: October 3, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 77 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Other:
• Placebo (OGTT)
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.
• Cinnamon (OGTT plus aqueous cinnamon extract)
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Egas Moniz - Cooperativa de Ensino Superior, CRL

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood glucose levels at beginning	Mean values of blood glucose levels from both control and experimental groups	At beginning (before intervention)
Primary	Blood glucose levels at 30 minutes	Mean values of blood glucose levels from both control and experimental groups	At 30 minutes after intervention
Primary	Blood glucose levels at 60 minutes	Mean values of blood glucose levels from both control and experimental groups	At 60 minutes after intervention
Primary	Blood glucose levels at 90 minutes	Mean values of blood glucose levels from both control and experimental groups	At 90 minutes after intervention
Primary	Blood glucose levels at 120 minutes	Mean values of blood glucose levels from both control and experimental groups	At 120 minutes after intervention
Primary	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)	At 120 minutes after intervention
Primary	Variation of blood glucose maximum concentration	Mean values of glucose maximum concentration variation	At 60 minutes after intervention
Secondary	Anthropometric parameters - body weight	Mean values of body weight (in kilogram - Kg)	At baseline
Secondary	Anthropometric parameters - height	Mean values of Height (in centimeters - cm)	At baseline
Secondary	Anthropometric parameters - waist circumference	Mean values of waist circumference (in centimeters - cm)	At baseline
Secondary	Anthropometric parameters - body mass index	Mean values of body mass index (Kg/m2), calculated as weight (Kg) divided by height (m2) squared (Kg/m2)	At baseline
Secondary	Anthropometric parameters - Skeletal muscle mass	Mean values of Skeletal muscle mass (in kilogram - Kg)	At baseline
Secondary	Anthropometric parameters - visceral fat	Mean values of visceral fat (cm3)	At baseline
Secondary	Pharmacological therapy	Percentage of antidiabetic orals (biguanide, sulfonylurea, alpha-glucosidase inhibitor, dipeptidyl peptidase 4 inhibitors	At baseline
Secondary	Total protein intake	Means values of total protein intake (in grams - g) obtained through The Food Processor SQL software	At baseline
Secondary	Total lipid intake	Means values of total lipid intake (in grams - g) obtained through The Food Processor SQL software	At baseline
Secondary	Total carbohydrate intake	Means values of total carbohydrate intake (in grams - g) obtained through The Food Processor SQL software	At baseline
Secondary	Total energy intake	Means values of total energy intake (in kilocalorie - Kcal) obtained through The Food Processor SQL software	At baseline
Secondary	Total polyphenols content	Mean values of total polyphenols content of cinnamon extract (mg/L equivalent of gallic acid)	At baseline
Secondary	Antioxidant activity	Mean values of antioxidant activity of cinnamon extract by FRAP and DPPH assays (micromol Trolox/L)	At baseline