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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
  Purpose

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


Condition Intervention
Hyperlipidemias
 Dietary Supplement: rice bran oil

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Effect of Low Calorie Diet With Rice Bran Oil on Cardiovascular Risk Factors in Hyperlipidemic Patients

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol
U.S. FDA Resources

Further study details as provided by Qazvin University Of Medical Sciences:

Primary Outcome Measures:
  • LDL, HDL, Cholesterol,Triglyceride(mg/dl) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    enzymatic reagents


Secondary Outcome Measures:
  • 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)


Estimated Enrollment: 50
Study Start Date: June 2008
Estimated Study Completion Date: June 2012
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: treatment, control 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)

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.

  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • hyperlipidemia

Exclusion Criteria:

  • pregnancy and lactation
  • cardiovascular disease
  • diabetes
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: May 10, 2012
Last Updated: May 16, 2012
Health Authority: Iran: Ministry of Health

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

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

ClinicalTrials.gov processed this record on May 16, 2013