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Effect of Cinnamomum Zeylanicum on Glycemic Levels of Adult Patients With Type 2 Diabetes

Evaluation of the Effect of Cinnamomum Zeylanicum on Glycemic Levels of Mexican Adult Patients With Type 2 Diabetes at 3 Months: Randomized Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04023539
Enrollment
30
Registered
2019-07-17
Start date
2019-09-04
Completion date
2020-04-23
Last updated
2020-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

Cinnamon, Type 2 diabetes, Diabetes, México, Cinnamomum zeylanicum, Randomized Controlled Trial, Glycated hemoglobin, Glucose control

Brief summary

Type 2 Diabetes (T2D) is protected against chronic hyperglycemia. This is one of the main causes of death in the country, being a public health problem worldwide. Some studies have shown that herbal products have beneficial effects in patients with diabetes by improving the metabolism of glucose and lipids. Cinnamomum Zeylanicum (C.Z.), colloquially cinnamon, is one of the components of the diet that has active biological substances with insulin mimetic properties. In Mexico, little has been investigated about the use of this therapy. Previous studies do not conclude if there is a statistically significant effect in the glycemic control of patients with diabetes. Therefore, it is proposed to evaluate the effect of the supplement consumption of C.Z. 3 months compared to a control group on the change in glycated hemoglobin (HbA1c) in Mexican adults with T2D. This is a randomized, single-blind clinical trial with T2D patients from the clinic CAAPS . Those that are divided into: intervention group with supplement of 2g daily C.Z. Oral route (capsules) for 90 days, and control group with placebo. The figures will be recorded: HbA1c, fasting plasma glucose, blood pressure, cholesterol, HDL, LDL, triglycerides, waist circumference, weight and body mass index.

Detailed description

Cinnamon, in in vitro and in vivo studies, has been shown to have biologically active substances with mimetic properties of insulin. In 1990 an unidentified component of cinnamon was extracted and named as an insulin-enhancing factor. The components of cinnamon bark oil (Ceylon) contain cinnamaldehyde (75%), cinnamyl acetate (5%), caryophyllene (3.3%), linalool (2.4%) and eugenol (2.2%). It is believed that the modality in which cinnamon expresses its effect on blood glucose can be attributed to its active component cinnamaldehyde. Within the 250 species of the Cinnamomum genus there are four types that are used as spice, the Cinnamomum Zeylanicum or Sri Lanka (also known as C. verum Ceylon) commonly referred to as true cinnamon; three very popular spices related to C. cassia are C. aromaticum (cinnamon china), C. loureirii (cinnamon vietnamese) and C. burmanni (cinnamon indonesia). One important difference between true cinnamon and cinnamon cassia is its coumarin content. The content of coumarin in cinnamomum zeylanicum is too low to cause health risks, while the level of coumarin in Cinnamomum aromaticum appears to be much higher and may pose health risks if consumed in larger quantities and on a regular basis. The use of cinnamon cassia as a regular supplement with meals is not recommended or the daily dose has been restricted in many countries due to the toxic effects of Cinnamomum aromaticum on the liver and coagulation. In contrast, cinnamomum zeylanicum has been shown to contain a lower amount of coumarin, and therefore it may be possible to use it at higher doses without toxic effects for longer periods. In vivo studies with cinnamomum zeylanicum have not shown significant adverse effects or toxicity in liver, kidney and / or pancreas. In a systematic review it was concluded that the evidence available in vitro and in vivo suggests that cinnamomum zeylanicum has antimicrobial, antiparasitic, anti-inflammatory and antioxidant properties. The authors also indicated that cinnamomum zeylanicum appears to lower blood glucose, serum cholesterol, and blood pressure, suggesting beneficial cardiovascular effects. The mechanism of this hypoglycaemic action is not entirely clear, but can be attributed to an increase in serum insulin levels, storage of liver glycogen, better signaling of the insulin receptor, an insulinomimetic effect, or reduction of alpha activity intestinal -glucosidase. In clinical terms, these actions could lead to improvements in glycemic control and insulin sensitivity, and a possible reduction in the complications of diabetes. In Mexico, little has been investigated on the use of this alternative therapy. In other countries, such as the United States, the United Kingdom, China, Pakistan and Germany, studies have been conducted on the potential effects of cinnamomum in in vitro, in vivo and in human studies. The effect of C. zeylanicum on glycemic control is inconclusive due to the contradictory results of the literature, some authors found statistically significant changes in glycosylated hemoglobin or fasting plasma glucose in randomized clinical trials compared with a placebo group. On the other hand, several authors report not having found significant changes in glucose levels in the study subjects. In the case of the Mexican population, no scientific studies were found that address the use of cinnamomum as an alternative therapy-alone or combined-in the control of glycemic levels in patients with diabetes. Therefore, in this study we propose to evaluate the effect of cinnamomum zeylanicum supplement consumption at 3 months compared to a control group (placebo) on the change in HbA1c in Mexican adults with T2D.

Interventions

OTHERPlacebo

Placebo capsules

DIETARY_SUPPLEMENTCinnamomum zeylanicum

Capsules of 2 g cinnamomum zeylanicum orally

Sponsors

Universidad de Sonora
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

A simple blinding (participants blinded to the belonging group). The person who will randomize the participants will not be involved in the recruitment of participants. This will be done when we have the total sample of participants.

Intervention model description

Randomized Controlled Trial This is a simple blind randomized clinical trial with patients with type 2 diabetes, the subjects will be divided into two groups, the intervention supplemented with 2 g daily of cinnamomum zeylanicum orally (capsules) and the control group with a placebo. There will be a follow-up of 3 months every two weeks to measure the variables of interest in the study.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Subjects with a prior medical diagnosis of T2D * Mexican adults (\> 18 years) * Treatments only with oral hypoglycemic agents * HbA1c \>6.5% and \<10% * Attendees to two participating primary health care centers.

Exclusion criteria

* Patients who have an allergy to cinnamon or wheat flour. * Treatments with insulin * Gastrointestinal problems or any condition in cinnamon is not well tolerated or contraindicated * Cardiovascular, hepatic or renal disease. * Use of addictive substances as drugs. * Pregnant or lactation * Psychiatric condition that prevents adherence to treatment * Use of a supplement with an effect on glucose

Design outcomes

Primary

MeasureTime frameDescription
Glycated hemoglobinbaseline to 3 monthsChange in glycated hemoglobin

Secondary

MeasureTime frameDescription
Total cholesterolbaseline to 3 monthsChange in total cholesterol
HDLbaseline to 3 monthsChange in HDL Cholesterol
LDLbaseline to 3 monthsChange in LDL Cholesterol
Triglyceridesbaseline to 3 monthsChange in Triglycerides
Fasting plasma glucosebaseline to 3 monthsChange in fasting plasma glucose
Waist circumferencebaseline to 3 monthsChange in waist circumference
Body Mass Indexbaseline to 3 monthsChange in the Body Mass Index
Blood pressurebaseline to 3 monthsChange in blood pressure
Weightbaseline to 3 monthsChange in Weight

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026