Development and Evaluation of a Web-based Diet Quality Screener for Vegans - BELGIUM

NCT ID: NCT06861205

Last Updated: 2025-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-01

Study Completion Date

2025-12-31

Brief Summary

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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, socioeconomic status 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

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Conditions

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Healthy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Omnivorous

Participants following an omnivor diet

This is an observational study

Intervention Type OTHER

This is an observational study

Vegan

Participants following a vegan diet

This is an observational study

Intervention Type OTHER

This is an observational study

Interventions

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This is an observational study

This is an observational study

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. 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)
2. Self-reported omnivores. Consuming on average daily (at least 5 times/week) meat/meat products.
3. Age 18 to 65 years (1:1 ratio 18-35,99 and 36-65)
4. Males and females (1:1 ratio)

Exclusion Criteria

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

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hogeschool Gent

UNKNOWN

Sponsor Role collaborator

University Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stefaan De Henauw, PhD

Role: PRINCIPAL_INVESTIGATOR

University Ghent

Locations

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UZ Gent

Ghent, , Belgium

Site Status

Countries

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Belgium

References

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Kronsteiner-Gicevic S, Bogl LH, Wakolbinger M, Muller S, Dietrich J, De Keyzer W, Bullon-Vela V, Selinger E, Keller V, Martinez Tabar A, Asif T, Craig L, Kyle J, Schlesinger S, Koder C, Ouradova A, Henikova M, Van Lippevelde W, Cahova M, Martinez Gonzalez MA, Willett W, Bes-Rastrollo M, Gojda J, De Henauw S, Keller M, Kuzma M, Schernhammer E. Development of the VEGANScreener, a Tool for a Quick Diet Quality Assessment among Vegans in Europe. Nutrients. 2024 Apr 29;16(9):1344. doi: 10.3390/nu16091344.

Reference Type BACKGROUND
PMID: 38732591 (View on PubMed)

Study Documents

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Document Type: Study Protocol

View Document

Related Links

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Other Identifiers

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G0G5121N

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

No. 727565

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HOGENT

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

ONZ-2023-0169

Identifier Type: -

Identifier Source: org_study_id

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