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

Primary Purpose

Hyperlipidemias

Status

Unknown status

Phase

Not Applicable

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

rice bran oil

About this trial

This is an interventional treatment trial for Hyperlipidemias focused on measuring rice bran oil, diet, cardiovascular disease, low density lipoprotein, total cholesterol

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

hyperlipidemia

Exclusion Criteria:

pregnancy and lactation
cardiovascular disease
diabetes

Sites / Locations

Qazvin University of Medical Sciences

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

treatment, control

Arm Description

Outcomes

Primary Outcome Measures

LDL, HDL, Cholesterol,Triglyceride(mg/dl)

enzymatic reagents

Secondary Outcome Measures

BMI (Kg/m2)

weight/(height)2

WHR (Ratio)

Waist(Cm)/Hip(Cm)

Full Information

NCT ID

NCT01600313

First Posted

May 10, 2012

Last Updated

May 16, 2012

Sponsor

Qazvin University Of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT01600313

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2012

Overall Recruitment Status

Unknown status

Study Start Date

June 2008 (undefined)

Primary Completion Date

May 2010 (Actual)

Study Completion Date

June 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Qazvin University Of Medical Sciences

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to determine the effect of rice bran oil with low calorie diet on lipid profiles.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperlipidemias

Keywords

rice bran oil, diet, cardiovascular disease, low density lipoprotein, total cholesterol

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Investigator

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

treatment, control

Arm Type

Experimental

Intervention Type

Dietary Supplement

Intervention Name(s)

rice bran oil

Other Intervention Name(s)

King rice bran oil, Bangkok, Thailand)

Intervention Description

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

Primary Outcome Measure Information:

Title

LDL, HDL, Cholesterol,Triglyceride(mg/dl)

Description

enzymatic reagents

Time Frame

30 days

Secondary Outcome Measure Information:

Title

BMI (Kg/m2)

Description

weight/(height)2

Time Frame

Baseline and 4 weeks after intervention

Title

WHR (Ratio)

Description

Waist(Cm)/Hip(Cm)

Time Frame

Baseline and 4 weeks after intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: hyperlipidemia Exclusion Criteria: pregnancy and lactation cardiovascular disease diabetes

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mostafa Noroozi, PhD

Organizational Affiliation

Qazvin University of Medical Sceience

Official's Role

Principal Investigator

Facility Information:

Facility Name

Qazvin University of Medical Sciences

City

Qazvin

ZIP/Postal Code

34197-59811

Country

Iran, Islamic Republic of

12. IPD Sharing Statement

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

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