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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Dr. Mostafa Noroozi, Qazvin University Of Medical Sciences

ClinicalTrials.gov Identifier:

NCT01600313

First received: May 10, 2012

Last updated: May 16, 2012

Last verified: May 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

May 10, 2012

Last Updated Date

May 16, 2012

Start Date ^ICMJE

June 2008

Primary Completion Date

May 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

LDL, HDL, Cholesterol,Triglyceride(mg/dl) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

enzymatic reagents

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01600313 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

BMI (Kg/m2) [ Time Frame: Baseline and 4 weeks after intervention ] [ Designated as safety issue: Yes ]
weight/(height)2
WHR (Ratio) [ Time Frame: Baseline and 4 weeks after intervention ] [ Designated as safety issue: Yes ]
Waist(Cm)/Hip(Cm)

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Hyperlipidemias

Intervention ^ICMJE

Dietary Supplement: rice bran oil

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

Other Names:

rice bran oil
King rice bran oil, Bangkok, Thailand)

Study Arm (s)

Experimental: treatment, control

Intervention: Dietary Supplement: rice bran oil

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

June 2012

Primary Completion Date

May 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

hyperlipidemia

Exclusion Criteria:

pregnancy and lactation
cardiovascular disease
diabetes

Gender

Both

Ages

25 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Iran, Islamic Republic of

Administrative Information

NCT Number ^ICMJE

NCT01600313

Other Study ID Numbers ^ICMJE

QUMS-2225

Has Data Monitoring Committee

Yes

Responsible Party

Dr. Mostafa Noroozi, Qazvin University Of Medical Sciences

Study Sponsor ^ICMJE

Qazvin University Of Medical Sciences

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Mostafa Noroozi, PhD

Qazvin University of Medical Sceience

Information Provided By

Qazvin University Of Medical Sciences

Verification Date

May 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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