Berberine and Cinnamon in Management of Diabetes

Sponsor

National Nutrition and Food Technology Institute (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05570357

Collaborator

(none)

Enrollment

Arms

3.3

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes	Dietary Supplement: Berberine+Cinnamon Other: Placebo	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

42 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

The Effects of Berberine and Cinnamon Supplementation on Diabetes Mangement

Anticipated Study Start Date :

Nov 1, 2022

Anticipated Primary Completion Date :

Feb 1, 2023

Anticipated Study Completion Date :

Feb 10, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Intervention	Dietary Supplement: Berberine+Cinnamon The supplements contains 400 mg Berberine, and 200 mg Cinnamon extract, and trace amounts of vitamins and minerals
Placebo Comparator: Placebo	Other: Placebo Placebo contains Maltodexterin

Arm

Intervention/Treatment

Active Comparator: Intervention

Dietary Supplement: Berberine+Cinnamon

The supplements contains 400 mg Berberine, and 200 mg Cinnamon extract, and trace amounts of vitamins and minerals

Placebo Comparator: Placebo

Other: Placebo

Placebo contains Maltodexterin

Outcome Measures

Primary Outcome Measures

HbA1C [12th week]
HbA1C change from baseline

Secondary Outcome Measures

Fasting blood sugar [12th week]
Blood sugar change from baseline
blood Insulin [12th week]
insulin change from baseline
Lipid profile [12th week]
lipid profiles change from baseline

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age 20-65 years
Diagnosed type-2 diabetes mellitus during the last 1 years
Currently only taking oral antidiabetic agents for the last 3 months
HbA1c 6.5-8.0%

Exclusion Criteria:

Patients with an allergy to berberine /cinamon
Patients using insulin therapy
Patients with raised baseline serum creatinine level (>1.5 mg/dl in men or > 1.2 mg/dl in women)
Lactation, pregnancy
Patients with any malignancy
Patients with unrelated chronic illness
Patients with cardiac, liver or respiratory failure

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

National Nutrition and Food Technology Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr Azita Hekmatdoost, Prof., National Nutrition and Food Technology Institute

ClinicalTrials.gov Identifier:

NCT05570357

Other Study ID Numbers:

996401

First Posted:

Oct 6, 2022

Last Update Posted:

Oct 6, 2022

Last Verified:

Oct 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Dr Azita Hekmatdoost, Prof., National Nutrition and Food Technology Institute

Diabetes

Berberine

Cinnamon

Additional relevant MeSH terms:

Diabetes Mellitus

Study Results

No Results Posted as of Oct 6, 2022