Effect of Low Calorie Diet With Rice Bran Oil on Cardiova... | NCT01600313

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

NCT01600313

Sponsor

Qazvin University Of Medical Sciences

Status

Unknown status

Last Update Posted

May 17, 2012Estimated

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Hyperlipidemias

Interventions

rice bran oil

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

May 2010Actual

Completion Date

Jun 2012Estimated

First Submitted Date

May 10, 2012

First Submission Date that Met QC Criteria

May 16, 2012

First Posted Date

May 17, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 16, 2012

Last Update Posted Date

May 17, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Mostafa Noroozi, Principal investigator, Qazvin University Of Medical SciencesPrincipal Investigator

Lead Sponsor

Qazvin University Of Medical SciencesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
treatment, control	Experimental		Dietary Supplement: rice bran oil

Interventions

Name	Type	Description	Arm Group Labels	Other Names
rice bran oil	Dietary Supplement	Treatment group received the low - calorie diet with(30g/day) rice bran oil	treatment, control

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
LDL, HDL, Cholesterol,Triglyceride(mg/dl)	enzymatic reagents	30 days

Secondary Outcomes

Measure	Description	Time Frame
BMI (Kg/m2)	weight/(height)2	Baseline and 4 weeks after intervention
WHR (Ratio)	Waist(Cm)/Hip(Cm)	Baseline and 4 weeks after intervention

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

hyperlipidemia

Exclusion Criteria:

pregnancy and lactation
cardiovascular disease
diabetes

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mostafa Noroozi, PhD	Qazvin University of Medical Sceience	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Qazvin University of Medical Sciences		Qazvin	Qazvin Province	34197-59811	Iran

Condition Browse Module

MeSH Terms

ID	Term
D006949	Hyperlipidemias
D002318	Cardiovascular Diseases

Ancestor Terms

ID	Term
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000073879	Rice Bran Oil
D013619	Tacrine

Ancestor Terms

ID	Term
D004042	Dietary Fats, Unsaturated
D004041	Dietary Fats
D005223	Fats
D008055	Lipids

Browse Leaves

Not provided

Browse Branches

Not provided