Type 2 Diabetes Clinical Trial
Official title:
The Effects of Crocin Supplementation on Metabolic Parameters, Oxidative Stress, AMP- Activated Protein Kinase and Inflammation-promoting Genes Expression in Peripheral Blood Mononuclear Cells in Patients With Type 2 Diabetes
| NCT number | NCT04163757 |
| Other study ID # | 899 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | January 20, 2019 |
| Est. completion date | June 3, 2019 |
| Verified date | November 2019 |
| Source | National Nutrition and Food Technology Institute |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
To study the effects of crocin supplement in patients with type 2 diabetes, 50 patients will be randomly allocated to placebo group and 2 tablets of crocin for 12 weeks. At the first and the end of the intervention, lipid profiles, blood pressure, blood sugar, inflammatory and anthropometric factors will be assessed and compared between groups.
| Status | Completed |
| Enrollment | 50 |
| Est. completion date | June 3, 2019 |
| Est. primary completion date | March 6, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 40 Years to 65 Years |
| Eligibility |
Inclusion Criteria: Age of 40 to 65 years type 2 diabetes: and body mass index range of 18.5 to 30 kg/m2 Exclusion Criteria: pregnancy or lactation A history of Cardiovascular disease, Pulmonary disease, Renal disease |
| Country | Name | City | State |
|---|---|---|---|
| Iran, Islamic Republic of | National Nutrition and Food Technology Research Institute | Tehran |
| Lead Sponsor | Collaborator |
|---|---|
| National Nutrition and Food Technology Institute | Ali Dastkhosh, Vahideh Behrouz |
Iran, Islamic Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | type 2 diabetes | number of participants with normal plasma glucose | 12 weeks |
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