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

NCT06861205 | Active Not Recruiting DMC

• 4 other identifiers: ONZ-2023-0169G0G5121NNo. 727565HOGENT
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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, 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Validity of the vegan screener

  The validity will be assessed by calculating associations between the screener and reference method.

  Baseline

Secondary Outcomes (38)

• Dietary intake

  Baseline

• Food habits

  Baseline

• Vitamin D status

  Baseline

• Homocysteine status

  Baseline

• holo-transcobalamin

  Baseline

Other Outcomes (3)

• Physical Activity

  Baseline

• Blood pressure

  Baseline

• Heart rate

  Baseline

Study Arms (2)

Omnivorous

Participants following an omnivor diet

Other: This is an observational study

Vegan

Participants following a vegan diet

Other: This is an observational study

Interventions

This is an observational study OTHER

This is an observational study

Omnivorous; Vegan

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: An equal number of male and female participants will be included. Inclusion is based on self-representation of gender identity.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Ghent: lead
• Hogeschool Gent: collaborator

Study Sites (1)

UZ Gent

Ghent, Belgium

Location

Related Publications (1)

• 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.

  PMID: 38732591 BACKGROUND

Related Links

• Project website

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine and saliva samples will be collected

Study Officials

• Stefaan De Henauw, PhD

  University Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: March 6, 2025
• Study Start: July 1, 2023
• Primary Completion: April 30, 2025
• Study Completion: December 31, 2025
• Last Updated: March 6, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

BE (1)