Validation of a Food Frequency Questionnaire for the Asse... | NCT03409445

Studies
Validation of a Food Frequency Questionnaire for the Assessment of Omega-3 Fatty Acid Intake

NCT03409445

Sponsor

Isabelle Herter-Aeberli

Status

Completed

Last Update Posted

Jul 26, 2018Actual

Enrollment

152Actual

Phase

Not provided

Conditions

Healthy

Interventions

no intervention

Countries

Switzerland

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

Jul 2018

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 15, 2018Actual

Primary Completion Date

Jul 25, 2018Actual

Completion Date

Jul 25, 2018Actual

First Submitted Date

Jan 18, 2018

First Submission Date that Met QC Criteria

Jan 23, 2018

First Posted Date

Jan 24, 2018Actual

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

Jul 25, 2018

Last Update Posted Date

Jul 26, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Isabelle Herter-Aeberli, Principle investigator, Swiss Federal Institute of TechnologySponsor-Investigator

Lead Sponsor

Isabelle Herter-AeberliOTHER

Collaborators

Name	Class
University Children's Hospital, Zurich	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

As essential nutrients omega 3 fatty acids contribute to normal growth and development. Inadequate intake is linked to the development of chronic diseases such as coronary heart disease, high blood pressure, cancer, arthritis, psychological illnesses and allergies. Therefore, it is important to be able to reliably detect the intake of these fatty acids. Due to eating habits varying in different countries the questionnaire documenting dietary habits needs to be adapted to the situation in question. Based on a US version the investigators developed a questionnaire suitable for Switzerland and now wish to validate it by measuring the fatty acid composition of red blood cells, which will provide information on the intake of the various fatty acids.

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

152Actual

Name	Type	Description	Arm Group Labels	Other Names
no intervention	Other	no intervention (observational study)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fatty acid composition of red blood cells due to dietary habits	Fatty acid composition of red blood cells due to dietary habits	1 day ( first visit)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy males and females aged 18 to 60

Exclusion Criteria:

known disorders of the gastrointestinal tract which can lead to malabsorption
intake of medication which could affect the absorption of any nutrients
Pregnant or breast-feeding women

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Healthy adults

Sampling Method

Non-Probability Sample