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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01600313
Other study ID # QUMS-2225
Secondary ID
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


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
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