Analysis of the effectiveness of cinnamon (Cinnamomum verum) in the reduction of glycemic and lipidic levels of adults with type 2 diabetes: A study protocol

BACKGROUND: Type 2 Diabetes Mellitus (T2DM) is a chronic disease that is increasing the number of cases worldwide. The treatments currently used have not worked as expected. Alternative and complementary medicines were inserted in health services, especially in primary care, as an attempt to minimize risks and help control diseases such as diabetes. Among the herbal medicines used stands out cinnamon, which can serve as an adjuvant in the control of diabetes. OBJECTIVE: To analyze the effectiveness of 3 grams of cinnamon (Cinnamomum verum) per day for 90 days in reducing glycemic and lipid levels in adults with T2DM compared with placebo METHODS: A randomized, double-blind, placebo-controlled, phase II trial, which will be conducted at basic health units in the city of Parnaíba, state of Piauí, Brazil. In total, 130 people diagnosed with T2DM, followed at health units, with hemoglobin A1c > 6.5%, and using oral antidiabetic medicines, are expected to participate in the study. The intervention will last for 3 months, and each participant will receive a total of 3 bottles containing 120 capsules in each bottle of cinnamon or placebo. Each person should take 4 capsules daily, for 90 days. The patients will be distributed into the 2 groups by performing block randomization (n = 6) at a ratio of 1:1 according to a code generated by a software. Assessments of socioeconomic, clinical, lifestyle, anthropometric, and laboratory variables will be performed in 2 separate visits. DISCUSSION: This study will be the first to investigate cinnamon to reduce glycemic, lipid, and anthropometric levels in Brazil. In case of favorable results, this therapy may be used as an alternative or additional medicine in cases where only oral antidiabetic agents are used and can promote the use of the product to minimize future complications of patients with diabetes and people who do not have the disease. TRIAL REGISTRATION: RBR-2KKB6D, registered on December 11th, 2018.