Dietary Determinants in Patients With Nonalcoholic Fatty... | NCT02649049

Studies
Dietary Determinants in Patients With Nonalcoholic Fatty Liver Disease (NAFLD)

NCT02649049

Sponsor

National Nutrition and Food Technology Institute

Status

Completed

Last Update Posted

Sep 22, 2016Estimated

Enrollment

1,200Actual

Phase

Not provided

Conditions

Dietary Intake
NAFLD

Interventions

there is no intervention

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

Sep 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2015

Primary Completion Date

Feb 2016Actual

Completion Date

Mar 2016Actual

First Submitted Date

Jan 3, 2016

First Submission Date that Met QC Criteria

Jan 5, 2016

First Posted Date

Jan 7, 2016Estimated

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

Sep 21, 2016

Last Update Posted Date

Sep 22, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr Azita Hekmatdoost, Associate Prof, National Nutrition and Food Technology InstitutePrincipal Investigator

Lead Sponsor

National Nutrition and Food Technology InstituteOTHER

Collaborators

Not provided

Description Module

Brief Summary

Patients with NAFLD and matched controls will be asked about their demographic status, and their previous year dietary intakes using a validated FFQ.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with NAFLD		Patients with NAFLD are the cases.	Other: there is no intervention
control group		Healthy people without NAFLD are controls.	Other: there is no intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
there is no intervention	Other		Patients with NAFLD control group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
nonalcoholic fatty liver disease diagnosed by Fibroscan	patients with confirmed diagnosis will be asked about their dietary intakes	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age more than 18
NAFLD was diagnosed by Fibroscan and other hepatic disorders ruled out

Exclusion Criteria:

not completing more than 10% of the questionnaire

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients with NAFLD diagnosed using Fibroscan without any other chronic disorders.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
NNFTRI clinic		Tehran	Tehran Province	19435	Iran

Condition Browse Module

MeSH Terms

ID	Term
D065626	Non-alcoholic Fatty Liver Disease

Ancestor Terms

ID	Term
D005234	Fatty Liver
D008107	Liver Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided