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

NCT05145673 | Completed

• 1 other identifier: 525cinnamon
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (7)

• Blood glucose levels at beginning

  Mean values of blood glucose levels from both control and experimental groups

  At beginning (before intervention)

• Blood glucose levels at 30 minutes

  Mean values of blood glucose levels from both control and experimental groups

  At 30 minutes after intervention

• Blood glucose levels at 60 minutes

  Mean values of blood glucose levels from both control and experimental groups

  At 60 minutes after intervention

• Blood glucose levels at 90 minutes

  Mean values of blood glucose levels from both control and experimental groups

  At 90 minutes after intervention

• Blood glucose levels at 120 minutes

  Mean values of blood glucose levels from both control and experimental groups

  At 120 minutes after intervention

• 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

• Variation of blood glucose maximum concentration

  Mean values of glucose maximum concentration variation

  At 60 minutes after intervention

Secondary Outcomes (13)

• Anthropometric parameters - body weight

  At baseline

• Anthropometric parameters - height

  At baseline

• Anthropometric parameters - waist circumference

  At baseline

• Anthropometric parameters - body mass index

  At baseline

• Anthropometric parameters - Skeletal muscle mass

  At baseline

Study Arms (2)

Placebo (OGTT)

PLACEBO COMPARATOR

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

Other: Placebo (OGTT)

Cinnamon (OGTT plus aqueous cinnamon extract)

EXPERIMENTAL

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

Other: Cinnamon (OGTT plus aqueous cinnamon extract)

Interventions

Placebo (OGTT) 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.

Placebo (OGTT)

Cinnamon (OGTT plus aqueous cinnamon extract) 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.

Cinnamon (OGTT plus aqueous cinnamon extract)

Eligibility Criteria

• Age: 35 Years - 77 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Egas Moniz - Cooperativa de Ensino Superior, CRL: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Glucose Tolerance Test

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: December 6, 2021
• Study Start: January 19, 2016
• Primary Completion: October 3, 2016
• Study Completion: October 31, 2016
• Last Updated: December 6, 2021

Record last verified: 2021-11