The Effects of Hesperidin and Flaxseed in Prediabetes

July 24, 2019 updated by: Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute

Evaluation of the Effects of Hesperidin and Flaxseed Supplementation in Patients With Prediabetes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: control
Other: control
no supplementation
ACTIVE_COMPARATOR: hesperidin and flaxseed
Dietary supplement: hesperidin and flaxseed
2 capsuls hesperidin and 30 g flaxseed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
prediabetes
Time Frame: 12 weeks
number of participants with normal plasma glucose
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Nutrition and Food Technology Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2018

Primary Completion (ACTUAL)

October 1, 2018

Study Completion (ACTUAL)

December 1, 2018

Study Registration Dates

First Submitted

October 11, 2018

First Submitted That Met QC Criteria

November 7, 2018

First Posted (ACTUAL)

November 9, 2018

Study Record Updates

Last Update Posted (ACTUAL)

July 26, 2019

Last Update Submitted That Met QC Criteria

July 24, 2019

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6781

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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