Diabetes
Conditions
Keywords
Diabetes, Berberine, Cinnamon
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.
Interventions
DIETARY_SUPPLEMENTBerberine+Cinnamon (TDS)
The supplements contains 400 mg Berberine, and 200 mg Cinnamon extract
OTHERPlacebo (TDS)
Placebo contains Maltodexterin
Sponsors
National Nutrition and Food Technology Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1C | 0 and 12th week | HbA1C change from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fasting blood sugar | 0 and 12th week | Blood sugar change from baseline |
| Lipid profile | 0 and 12th week | lipid profiles change from baseline |
| Anthropometric measurements | 0 and 12th week | weight, height, BMI, WC |
| Blood Pressure | 0 and 12th week | measuring according to the BP measurement guideline |
| CRP | 0 and 12th week | measuring the blood concentration of C-reactive protein |
Countries
Iran
Outcome results
None listed