Development and Evaluation of a Web-based Diet Quality Sc... | NCT06032234

Studies
Development and Evaluation of a Web-based Diet Quality Screener for Vegans (VEGANScreener)

NCT06032234

Sponsor

Isabelle Herter-Aeberli

Status

Completed

Last Update Posted

Dec 3, 2024Actual

Enrollment

89Actual

Phase

Not provided

Conditions

Healthy

Interventions

This is an observational study

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

Oct 2024

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

Sep 12, 2023Actual

Primary Completion Date

Mar 30, 2024Actual

Completion Date

Jul 31, 2024Actual

First Submitted Date

Aug 25, 2023

First Submission Date that Met QC Criteria

Sep 8, 2023

First Posted Date

Sep 11, 2023Actual

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

Nov 27, 2024

Last Update Posted Date

Dec 3, 2024Actual

Name	Class
Bern University of Applied Sciences	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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The primary objective of this study is to assess the construct validity and criterion validity for associations of the VEGANScreener with nutrient intakes from reference methods and associations with biomarkers of dietary intake. The investigators hypothesize that the screener is a valid tool to assess diet quality in the vegan population. The study will assess construct validity by testing whether the measure relates as it should to other measures (e.g., age, gender, education, SES differences).

The investigators will assess concurrent and predictive validity (types of criterion validity) by evaluating associations and agreement between 'gold standards', such as diet records, biomarkers, and multi-metabolite signatures of intake. The investigators will examine associations of vegan diet quality with biomarkers of nutritional status, biomarkers of disease, and anthropometric measures and hypothesize that a higher diet quality in vegans is associated with a more favourable profile among vegans, for example, a lower blood pressure. This study is part of the European VEGANScreener Consortium.

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

Retention

Enrollment

89Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Omnivorous		Participants following an omniviours diet	Other: This is an observational study
Vegan		Participants following a vegan diet	Other: This is an observational study

Interventions

Name	Type	Description	Arm Group Labels	Other Names
This is an observational study	Other	This is an observational study	Omnivorous Vegan

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Validity of the vegan screener	The validity will be assessed by calculating associations between the screener and reference method.	Baseline

Secondary Outcomes

Measure	Description	Time Frame
Dietary intake	Dietary intake will be assessed using a weighed food record	Baseline
Food habits	Food habits will be assessed using a food frequency questionnaire

Other Outcomes

Measure	Description	Time Frame
International Physical Activity Questionnaire iPAQ	Physical activity will be assessed using a questionnaire using the iPAQ	Baseline
Blood pressure	Systolic and diastolic blood pressure will be measured

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Self-reported vegans (≥2 years on a vegan diet; vegan diet defined as not consuming any dietary animal products more often than once/month, honey excluded)
Self-reported omnivores. Consuming on average daily (at least 5 times/week) meat/meat products.
Age 18 to 65 years (1:1 ratio 18-35,99 and 36-65)
Males and females (1:1 ratio)

Exclusion Criteria:

Self-identified pescatarians (excluding all meat, except for fish/seafood) and reductarians/flexitarians (intentionally reducing intake of animal-based products)
History of a disease known to affect intermediary metabolism (e.g., any diabetes on treatment, i.e. medication or lifestyle recommendations, thyreopathies, cancer etc.)
BMI>30 kg/m2
History of disease of intestinal integrity (i.e., inflammatory bowel disease, chronic pancreatitis, other malabsorption, etc.).
Pregnant or breastfeeding females.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Yes

Sex/Gender Description

An equal number of male and female participants will be included. Inclusion is based on self-representation of gender identity.

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Healthy participants following a vegan or omnivours diet (ratio 1:1).

Sampling Method

Non-Probability Sample