The Effects of Hesperidin and Flaxseed in Prediabetes

Overview

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.

Full Title of Study: “Evaluation of the Effects of Hesperidin and Flaxseed Supplementation in Patients With Prediabetes”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 1, 2018

Interventions

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

Arms, Groups and Cohorts

  • Active Comparator: hesperidin and flaxseed
  • Placebo Comparator: control

Clinical Trial Outcome Measures

Primary Measures

  • prediabetes
    • Time Frame: 12 weeks
    • number of participants with normal plasma glucose

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • National Nutrition and Food Technology Institute
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr Azita Hekmatdoost, Principal Investigator – National Nutrition and Food Technology Institute

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