Berberine and Cinnamon in Management of Diabetes

Diabetes Clinical Trial

Official title:

The Effects of Berberine and Cinnamon Supplementation on Diabetes Mangement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05570357
• Other study ID #: 996401
• Status: Completed
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: February 10, 2023

Study information

• Verified date: June 2024
• Source: National Nutrition and Food Technology Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this randomized clinical trial, patients with diabetes will be randomly assigned to receive either Berberine, and Cinnamon supplements or placebo for 12 weeks. Then the glycemic characteristics will be compared in two groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: February 10, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age 30-70 years

• Diagnosed type-2 diabetes mellitus (based on American Diabetes Association criteria)

Exclusion Criteria:

• Patients with an allergy to berberine /cinamon

• Lactation, pregnancy

• Patients with any malignancy

• Patients with unrelated chronic illness

• Patients with cardiac, liver or respiratory failure

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Intervention

Dietary Supplement:
• Berberine+Cinnamon (TDS)
The supplements contains 400 mg Berberine, and 200 mg Cinnamon extract

Other:
• Placebo (TDS)
Placebo contains Maltodexterin

Locations

Country	Name	City	State
Iran, Islamic Republic of	Azita Hekmatdoost	Tehran	Middle East

Sponsors (1)

Lead Sponsor	Collaborator
National Nutrition and Food Technology Institute

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1C	HbA1C change from baseline	0 and 12th week
Secondary	Fasting blood sugar	Blood sugar change from baseline	0 and 12th week
Secondary	Lipid profile	lipid profiles change from baseline	0 and 12th week
Secondary	Anthropometric measurements	weight, height, BMI, WC	0 and 12th week
Secondary	Blood Pressure	measuring according to the BP measurement guideline	0 and 12th week
Secondary	CRP	measuring the blood concentration of C-reactive protein	0 and 12th week