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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date November 2018
Source National Nutrition and Food Technology Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
hesperidin and flaxseed
2 capsuls hesperidin and 30 g flaxseed
Other:
control
no supplementation

Locations

Country Name City State
Iran, Islamic Republic of National Nutrition and Food Technology Research Institute Tehran

Sponsors (1)

Lead Sponsor Collaborator
National Nutrition and Food Technology Institute

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary prediabetes number of participants with normal plasma glucose 12 weeks
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