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

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ClinicalTrials.gov Identifier: NCT01600313
Recruitment Status : Unknown
Verified May 2012 by Dr. Mostafa Noroozi, Qazvin University Of Medical Sciences.
Recruitment status was:  Active, not recruiting
First Posted : May 17, 2012
Last Update Posted : May 17, 2012
Sponsor:
Information provided by (Responsible Party):
Dr. Mostafa Noroozi, Qazvin University Of Medical Sciences

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

Condition or disease Intervention/treatment Phase
Hyperlipidemias Dietary Supplement: rice bran oil Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Effect of Low Calorie Diet With Rice Bran Oil on Cardiovascular Risk Factors in Hyperlipidemic Patients
Study Start Date : June 2008
Actual Primary Completion Date : May 2010
Estimated Study Completion Date : June 2012

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. LDL, HDL, Cholesterol,Triglyceride(mg/dl) [ Time Frame: 30 days ]
    enzymatic reagents


Secondary Outcome Measures :
  1. BMI (Kg/m2) [ Time Frame: Baseline and 4 weeks after intervention ]
    weight/(height)2

  2. WHR (Ratio) [ Time Frame: Baseline and 4 weeks after intervention ]
    Waist(Cm)/Hip(Cm)



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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • hyperlipidemia

Exclusion Criteria:

  • pregnancy and lactation
  • cardiovascular disease
  • diabetes

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01600313


Locations
Iran, Islamic Republic of
Qazvin University of Medical Sciences
Qazvin, Iran, Islamic Republic of, 34197-59811
Sponsors and Collaborators
Qazvin University Of Medical Sciences
Investigators
Principal Investigator: Mostafa Noroozi, PhD Qazvin University of Medical Sceience

Responsible Party: Dr. Mostafa Noroozi, Principal investigator, Qazvin University Of Medical Sciences
ClinicalTrials.gov Identifier: NCT01600313     History of Changes
Other Study ID Numbers: QUMS-2225
First Posted: May 17, 2012    Key Record Dates
Last Update Posted: May 17, 2012
Last Verified: May 2012

Keywords provided by Dr. Mostafa Noroozi, Qazvin University Of Medical Sciences:
rice bran oil
diet
cardiovascular disease
low density lipoprotein
total cholesterol

Additional relevant MeSH terms:
Hyperlipidemias
Hyperlipoproteinemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Rice bran oil
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents