PreDiabetes Clinical Trial
Official title:
Evaluation of the Effects of Hesperidin and Flaxseed Supplementation in Patients With Prediabetes
NCT number | NCT03737422 |
Other study ID # | 6781 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 1, 2018 |
Est. completion date | December 1, 2018 |
Verified date | November 2018 |
Source | National Nutrition and Food Technology Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To study the effects of Hesperidin and flaxseed supplement in patients with prediabetes, 50 patients will be randomly allocated to control group or 2 capsules Hesperidin and 30 gram flaxseed for 12 weeks; both groups will be advised to adherence the investigators' diet and exercise program too. 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 | 48 |
Est. completion date | December 1, 2018 |
Est. primary completion date | October 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Age of 18 to 70 years prediabetes: impaired fasting glucose (>100 mg/dL) and/or HbA1C 5.7% to 6.5%, and overweight or obese with body mass index range of 25 to 40 kg/m2 Exclusion Criteria: - pregnancy or lactation - A history of Cardiovascular disease, Pulmonary disease, Renal disease & Celiac disease; Cirrhosis - Following program to lose weight in recent 3 mo |
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 |
Iran, Islamic Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | prediabetes | number of participants with normal plasma glucose | 12 weeks |
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