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

Development and Evaluation of a Web-based Diet Quality Screener for Vegans (VEGANScreener): a Cross-sectional, Observational, Multicenter, Clinical Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy
• Intervention / Treatment: Other: This is an observational study

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium
    • UZ Gent

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Vegan; Participants following a vegan diet	Other: This is an observational study; This is an observational study
Omnivorous; Participants following an omnivor diet	Other: This is an observational study; This is an observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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	Baseline
Vitamin D status	Vitamin D status will be measured from venous blood samples	Baseline
Homocysteine status	Homocysteine will be measured from venous blood samples	Baseline
holo-transcobalamin	holo-transcobalamin will be measured from venous blood samples	Baseline
Vitamin B2 status	Vitamin B2 will be measured from venous blood samples	Baseline
Vitamin C status	Vitamin C will be measured from venous blood samples	Baseline
Folic acid status	Folic acid will be measured from venous blood samples	Baseline
Magnesium status	Magnesium status will be determined from venous blood samples	Baseline
Zinc status	Zinc status will be determined from venous blood samples	Baseline
Selenoprotein-P status	Selenoprotein-P status will be determined from venous blood samples	Baseline
Ferritin concentration	Ferritin concentration will be determined from venous blood samples	Baseline
Soluble transferrin receptor concentration	Soluble transferrin receptor will be determined from venous blood samples	Baseline
Hemoglobin concentration	Hemoglobin will be determined from venous blood samples	Baseline
Creatinine concentration	Creatinine will be determined from venous blood samples	Baseline
Uric acid concentration	Uric acid will be determined from venous blood samples	Baseline
Urea concentration	Urea will be determined from urine samples samples	Baseline
C-reactive protein concentration	The inflammatory marker hsCRP will be determined from serum	Baseline
Triglyceride concentration	Triglyceride concentration will be determine from venous blood samples	Baseline
Eicosapentanoic acid	Eicosapentanoic acid (in % of total FA) will be determine from venous blood samples	Baseline
Docosahexanoic acid	Docosahexanoic acid (in % of total FA) will be determine from venous blood samples	Baseline
LDL-cholesterol concentration	LDL-cholesterol concentration will be determine from venous blood samples	Baseline
HDL-Cholesterol concentration	HDL-Cholesterol concentration will be determine from venous blood samples	Baseline
Cholesterol concentration	Cholesterol concentration will be determine from venous blood samples	Baseline
Glucose concentration	Glucose will be measured from venous blood samples	Baseline
VEGANScreener	The VEGANScreener assesses diet quality using 29 questions of frequency of consumption of different foods and food groups.	Baseline and day 2
Weight	Weight will be measured in kg	Baseline
Height	Height will be measured in m	Baseline
Waist circumference	Waist circumference will be measured in cm	Baseline
Hip circumference	Hip circumference will be measured in cm	Baseline
Methylmalonic acid	Methylmalonic acid will be measured from venous blood samples	Baseline
Iodine concentration	Iodine status will be determined from urine samples	Baseline
Potassium concentration	Potassium status will be determined from urine samples	Baseline
Sodium concentration	Sodium status will be determined from urine samples	Baseline
Calcium concentration	Calcium status will be determined from urine samples	Baseline
Creatinine concentration (urine)	Creatinine will be determined from urine samples	Baseline
Free fatty acid concentration	Free fatty acid concentration will be determine from venous blood samples	Baseline
Well being	Participants well being will be assessed using a questionnaire. The scale of each question ranges from 0 to 10, 10 representing the highest well being	Baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure	Systolic and diastolic blood pressure will be measured	Baseline
Heart rate	Heart rate will be measured	Baseline
Physical Activity	Physical activity will be assessed using the International Physical Activity Questionnaire (iPAQ)	Baseline

Collaborators and Investigators

• Sponsor: University Ghent
• Collaborators: Hogeschool Gent
• Investigators: Principal Investigator: Stefaan De Henauw, PhD, University Ghent

Publications and helpful links

General Publications

• 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.

Helpful Links

• Project website

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: November 6, 2024
• First Submitted That Met QC Criteria: March 5, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 5, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: ONZ-2023-0169; G0G5121N (Other Grant/Funding Number: Research Foundation Flanders FWO); No. 727565 (Other Grant/Funding Number: European Union's Horizon 2020 Research and Innovation Programme ERA-Net HDHL-INTIMIC); HOGENT (Other Grant/Funding Number: University of Applied Sciences and Arts)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data transfer agreements are made with all parties within the VEGANScreener consortium
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Study Data/Documents

1. Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No