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

NCT ID: NCT05145673

Last Updated: 2021-12-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-19
• Study Completion Date: 2016-10-31

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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Cinnamon (OGTT plus aqueous cinnamon extract)

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

Group Type: EXPERIMENTAL

Cinnamon (OGTT plus aqueous cinnamon extract)

Intervention Type: OTHER

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.

Placebo (OGTT)

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

Group Type: PLACEBO_COMPARATOR

Placebo (OGTT)

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 77 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Egas Moniz - Cooperativa de Ensino Superior, CRL

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

525cinnamon

Identifier Type: -

Identifier Source: org_study_id