Clinical trial NCT05145673: 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
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: Egas Moniz - Cooperativa de Ensino Superior, CRL
Sponsor class: OTHER
First posted: 2021-12-06
Enrollment: 36
Sex: ALL
Minimum age (years): 35
Maximum age (years): 77
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Blood glucose levels at beginning
timeFrame: At beginning (before intervention)
measure: Blood glucose levels at 30 minutes
timeFrame: At 30 minutes after intervention
measure: Blood glucose levels at 60 minutes
timeFrame: At 60 minutes after intervention
measure: Blood glucose levels at 90 minutes
timeFrame: At 90 minutes after intervention
measure: Blood glucose levels at 120 minutes
timeFrame: At 120 minutes after intervention
measure: Incremental area under the curve of blood glucose
timeFrame: At 120 minutes after intervention
measure: Variation of blood glucose maximum concentration
timeFrame: At 60 minutes after intervention
Secondary outcomes:
measure: Anthropometric parameters - body weight
timeFrame: At baseline
measure: Anthropometric parameters - height
timeFrame: At baseline
measure: Anthropometric parameters - waist circumference
timeFrame: At baseline
measure: Anthropometric parameters - body mass index
timeFrame: At baseline
measure: Anthropometric parameters - Skeletal muscle mass
timeFrame: At baseline
measure: Anthropometric parameters - visceral fat
timeFrame: At baseline
measure: Pharmacological therapy
timeFrame: At baseline
measure: Total protein intake
timeFrame: At baseline
measure: Total lipid intake
timeFrame: At baseline
measure: Total carbohydrate intake
timeFrame: At baseline
measure: Total energy intake
timeFrame: At baseline
measure: Total polyphenols content
timeFrame: At baseline
measure: Antioxidant activity
timeFrame: At baseline
Other outcomes:
Locations:
Study officials:
References: