Clinical trial NCT06861205: Development and Evaluation of a Web-based Diet Quality Screener for Vegans - BELGIUM
Official title: Development and Evaluation of a Web-based Diet Quality Screener for Vegans (VEGANScreener): a Cross-sectional, Observational, Multicenter, Clinical Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Healthy
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: Hogeschool Gent
First posted: 2025-03-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy participants following a vegan or omnivours diet (ratio 1:1).

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Validity of the vegan screener
timeFrame: Baseline
Secondary outcomes:
measure: Dietary intake
timeFrame: Baseline
measure: Food habits
timeFrame: Baseline
measure: Vitamin D status
timeFrame: Baseline
measure: Homocysteine status
timeFrame: Baseline
measure: holo-transcobalamin
timeFrame: Baseline
measure: Methylmalonic acid
timeFrame: Baseline
measure: Vitamin B2 status
timeFrame: Baseline
measure: Vitamin C status
timeFrame: Baseline
measure: Folic acid status
timeFrame: Baseline
measure: Magnesium status
timeFrame: Baseline
measure: Zinc status
timeFrame: Baseline
measure: Selenoprotein-P status
timeFrame: Baseline
measure: Ferritin concentration
timeFrame: Baseline
measure: Soluble transferrin receptor concentration
timeFrame: Baseline
measure: Hemoglobin concentration
timeFrame: Baseline
measure: Creatinine concentration
timeFrame: Baseline
measure: Uric acid concentration
timeFrame: Baseline
measure: Urea concentration
timeFrame: Baseline
measure: Iodine concentration
timeFrame: Baseline
measure: Potassium concentration
timeFrame: Baseline
measure: Sodium concentration
timeFrame: Baseline
measure: Calcium concentration
timeFrame: Baseline
measure: Creatinine concentration (urine)
timeFrame: Baseline
measure: C-reactive protein concentration
timeFrame: Baseline
measure: Triglyceride concentration
timeFrame: Baseline
measure: Free fatty acid concentration
timeFrame: Baseline
measure: Eicosapentanoic acid
timeFrame: Baseline
measure: Docosahexanoic acid
timeFrame: Baseline
measure: LDL-cholesterol concentration
timeFrame: Baseline
measure: HDL-Cholesterol concentration
timeFrame: Baseline
measure: Cholesterol concentration
timeFrame: Baseline
measure: Glucose concentration
timeFrame: Baseline
measure: Well being
timeFrame: Baseline
measure: VEGANScreener
timeFrame: Baseline and day 2
measure: Weight
timeFrame: Baseline
measure: Height
timeFrame: Baseline
measure: Waist circumference
timeFrame: Baseline
measure: Hip circumference
timeFrame: Baseline
Other outcomes:
measure: Physical Activity
timeFrame: Baseline
measure: Blood pressure
timeFrame: Baseline
measure: Heart rate
timeFrame: Baseline
Locations:
city: Ghent
country: Belgium
facility: UZ Gent
Study officials:
affiliation: University Ghent
name: Stefaan De Henauw, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.