Berberine and Cinnamon in Management of Diabetes

June 9, 2024 updated by: Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute

The Effects of Berberine and Cinnamon Supplementation on Diabetes Mangement

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Placebo (TDS)
Placebo contains Maltodexterin
Active Comparator: Intervention
Dietary supplement: Berberine+Cinnamon (TDS)
The supplements contains 400 mg Berberine, and 200 mg Cinnamon extract

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1C
Time Frame: 0 and 12th week
HbA1C change from baseline
0 and 12th week

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Nutrition and Food Technology Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Actual)

January 1, 2023

Study Completion (Actual)

February 10, 2023

Study Registration Dates

First Submitted

October 2, 2022

First Submitted That Met QC Criteria

October 5, 2022

First Posted (Actual)

October 6, 2022

Study Record Updates

Last Update Posted (Actual)

June 11, 2024

Last Update Submitted That Met QC Criteria

June 9, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 996401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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