Effect of Low Calorie Diet With Rice Bran Oil on Cardiovascular Risk Factors in Hyperlipidemic Patients

May 16, 2012 updated by: Dr. Mostafa Noroozi, Qazvin University Of Medical Sciences
The purpose of this study is to determine the effect of rice bran oil with low calorie diet on lipid profiles.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This study is parallel groups' randomized clinical trial with a pre and post test design.

The study conducted on hyperglycemia patients who were healthy in other respects and were recruited from nutrition and diet therapy clinic. All subjects received a low calorie diet for 4 weeks from registered dietitian.

Treatment group received the low- calorie diet including (30g/day) rice bran oil.

Study Type

Interventional

Enrollment (Anticipated)

50

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

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • hyperlipidemia

Exclusion Criteria:

  • pregnancy and lactation
  • cardiovascular disease
  • diabetes

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: treatment, control
Treatment group received the low - calorie diet with(30g/day) rice bran oil
Other Names:
  • King rice bran oil, Bangkok, Thailand)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LDL, HDL, Cholesterol,Triglyceride(mg/dl)
Time Frame: 30 days
enzymatic reagents
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BMI (Kg/m2)
Time Frame: Baseline and 4 weeks after intervention
weight/(height)2
Baseline and 4 weeks after intervention
WHR (Ratio)
Time Frame: Baseline and 4 weeks after intervention
Waist(Cm)/Hip(Cm)
Baseline and 4 weeks after intervention

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Mostafa Noroozi, PhD, Qazvin University of Medical Sceience

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

June 1, 2008

Primary Completion (Actual)

May 1, 2010

Study Completion (Anticipated)

June 1, 2012

Study Registration Dates

First Submitted

May 10, 2012

First Submitted That Met QC Criteria

May 16, 2012

First Posted (Estimate)

May 17, 2012

Study Record Updates

Last Update Posted (Estimate)

May 17, 2012

Last Update Submitted That Met QC Criteria

May 16, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

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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