NCT01600313

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

May 10, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 17, 2012

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

May 17, 2012

Status Verified

May 1, 2012

Enrollment Period

1.9 years

First QC Date

May 10, 2012

Last Update Submit

May 16, 2012

Conditions

Hyperlipidemias

Keywords

rice bran oildietcardiovascular diseaselow density lipoproteintotal cholesterol

Outcome Measures

Primary Outcomes (1)

  • LDL, HDL, Cholesterol,Triglyceride(mg/dl)

    enzymatic reagents

    30 days

Secondary Outcomes (2)

  • BMI (Kg/m2)

    Baseline and 4 weeks after intervention

  • WHR (Ratio)

    Baseline and 4 weeks after intervention

Study Arms (1)

treatment, control

EXPERIMENTAL
Dietary Supplement: rice bran oil

Interventions

rice bran oilDIETARY_SUPPLEMENT

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

Also known as: King rice bran oil, Bangkok, Thailand)
treatment, control

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • hyperlipidemia

You may not qualify if:

  • pregnancy and lactation
  • cardiovascular disease
  • diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qazvin University of Medical Sciences

Qazvin, Qazvin Province, 34197-59811, Iran

Location

MeSH Terms

Conditions

HyperlipidemiasCardiovascular Diseases

Interventions

Rice Bran OilTacrine

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFats, UnsaturatedPlant OilsOilsPlant PreparationsBiological ProductsComplex MixturesAminoacridinesAcridinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Mostafa Noroozi, PhD

    Qazvin University of Medical Sceience

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 10, 2012

First Posted

May 17, 2012

Study Start

June 1, 2008

Primary Completion

May 1, 2010

Study Completion

June 1, 2012

Last Updated

May 17, 2012

Record last verified: 2012-05

Locations

IR(1)