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NCT Number: NCT06861205

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

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.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UZ Gent

Ghent, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

This is an observational study

Other

This is an observational study

Primary outcomes

  1. Validity of the vegan screener

    Time frame: Baseline

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

Secondary outcomes

  1. Dietary intake

    Time frame: Baseline

    Dietary intake will be assessed using a weighed food record

  2. Food habits

    Time frame: Baseline

    Food habits will be assessed using a food frequency questionnaire

  3. Vitamin D status

    Time frame: Baseline

    Vitamin D status will be measured from venous blood samples

  4. Homocysteine status

    Time frame: Baseline

    Homocysteine will be measured from venous blood samples

  5. holo-transcobalamin

    Time frame: Baseline

    holo-transcobalamin will be measured from venous blood samples

  6. Methylmalonic acid

    Time frame: Baseline

    Methylmalonic acid will be measured from venous blood samples

  7. Vitamin B2 status

    Time frame: Baseline

    Vitamin B2 will be measured from venous blood samples

  8. Vitamin C status

    Time frame: Baseline

    Vitamin C will be measured from venous blood samples

  9. Folic acid status

    Time frame: Baseline

    Folic acid will be measured from venous blood samples

  10. Magnesium status

    Time frame: Baseline

    Magnesium status will be determined from venous blood samples

  11. Zinc status

    Time frame: Baseline

    Zinc status will be determined from venous blood samples

  12. Selenoprotein-P status

    Time frame: Baseline

    Selenoprotein-P status will be determined from venous blood samples

  13. Ferritin concentration

    Time frame: Baseline

    Ferritin concentration will be determined from venous blood samples

  14. Soluble transferrin receptor concentration

    Time frame: Baseline

    Soluble transferrin receptor will be determined from venous blood samples

  15. Hemoglobin concentration

    Time frame: Baseline

    Hemoglobin will be determined from venous blood samples

  16. Creatinine concentration

    Time frame: Baseline

    Creatinine will be determined from venous blood samples

  17. Uric acid concentration

    Time frame: Baseline

    Uric acid will be determined from venous blood samples

  18. Urea concentration

    Time frame: Baseline

    Urea will be determined from urine samples samples

  19. Iodine concentration

    Time frame: Baseline

    Iodine status will be determined from urine samples

  20. Potassium concentration

    Time frame: Baseline

    Potassium status will be determined from urine samples

  21. Sodium concentration

    Time frame: Baseline

    Sodium status will be determined from urine samples

  22. Calcium concentration

    Time frame: Baseline

    Calcium status will be determined from urine samples

  23. Creatinine concentration (urine)

    Time frame: Baseline

    Creatinine will be determined from urine samples

  24. C-reactive protein concentration

    Time frame: Baseline

    The inflammatory marker hsCRP will be determined from serum

  25. Triglyceride concentration

    Time frame: Baseline

    Triglyceride concentration will be determine from venous blood samples

  26. Free fatty acid concentration

    Time frame: Baseline

    Free fatty acid concentration will be determine from venous blood samples

  27. Eicosapentanoic acid

    Time frame: Baseline

    Eicosapentanoic acid (in % of total FA) will be determine from venous blood samples

  28. Docosahexanoic acid

    Time frame: Baseline

    Docosahexanoic acid (in % of total FA) will be determine from venous blood samples

  29. LDL-cholesterol concentration

    Time frame: Baseline

    LDL-cholesterol concentration will be determine from venous blood samples

  30. HDL-Cholesterol concentration

    Time frame: Baseline

    HDL-Cholesterol concentration will be determine from venous blood samples

  31. Cholesterol concentration

    Time frame: Baseline

    Cholesterol concentration will be determine from venous blood samples

  32. Glucose concentration

    Time frame: Baseline

    Glucose will be measured from venous blood samples

  33. Well being

    Time frame: Baseline

    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

  34. VEGANScreener

    Time frame: Baseline and day 2

    The VEGANScreener assesses diet quality using 29 questions of frequency of consumption of different foods and food groups.

  35. Weight

    Time frame: Baseline

    Weight will be measured in kg

  36. Height

    Time frame: Baseline

    Height will be measured in m

  37. Waist circumference

    Time frame: Baseline

    Waist circumference will be measured in cm

  38. Hip circumference

    Time frame: Baseline

    Hip circumference will be measured in cm

Other outcomes

  1. Physical Activity

    Time frame: Baseline

    Physical activity will be assessed using the International Physical Activity Questionnaire (iPAQ)

  2. Blood pressure

    Time frame: Baseline

    Systolic and diastolic blood pressure will be measured

  3. Heart rate

    Time frame: Baseline

    Heart rate will be measured

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Collaborators

  • Hogeschool Gent

Registry information

Official study title

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

Acronym: VEGANScreener

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 6, 2025
Registry last updated
Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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