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

Hyperlipidemias Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01600313
• Other study ID #: QUMS-2225
• Status: Active, not recruiting
• Phase: N/A
• First received: May 10, 2012
• Last updated: May 16, 2012
• Start date: June 2008
• Est. completion date: June 2012

Study information

• Verified date: May 2012
• Source: Qazvin University Of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: June 2012
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 65 Years

Eligibility

Inclusion Criteria:

• hyperlipidemia

Exclusion Criteria:

• pregnancy and lactation

• cardiovascular disease

• diabetes

Study Design

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

Related Conditions & MeSH terms

• Hyperlipidemias

Intervention

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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Qazvin University of Medical Sciences	Qazvin

Sponsors (1)

Lead Sponsor	Collaborator
Qazvin University Of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LDL, HDL, Cholesterol,Triglyceride(mg/dl)	enzymatic reagents	30 days	Yes
Secondary	BMI (Kg/m2)	weight/(height)2	Baseline and 4 weeks after intervention	Yes
Secondary	WHR (Ratio)	Waist(Cm)/Hip(Cm)	Baseline and 4 weeks after intervention	Yes