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

Active, not recruiting

• Conditions: Healthy

• Registration Number: NCT06861205
• Lead Sponsor: University Ghent

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-01
• Status Verified: 2024-10
• Study First Submitted: 2024-11-06
• Study First Submitted QC: 2025-03-05
• Last Update Submitted: 2025-03-05
• Study First Posted: 2025-03-06
• Last Update Posted: 2025-03-06
• Primary Completion: 2025-04-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Validity of the vegan screener	Baseline	The validity will be assessed by calculating associations between the screener and reference method.

Secondary Outcome Measures

Name	Time	Method
Dietary intake	Baseline	Dietary intake will be assessed using a weighed food record
Food habits	Baseline	Food habits will be assessed using a food frequency questionnaire
Vitamin D status	Baseline	Vitamin D status will be measured from venous blood samples
Homocysteine status	Baseline	Homocysteine will be measured from venous blood samples
Ferritin concentration	Baseline	Ferritin concentration will be determined from venous blood samples
Soluble transferrin receptor concentration	Baseline	Soluble transferrin receptor will be determined from venous blood samples
holo-transcobalamin	Baseline	holo-transcobalamin will be measured from venous blood samples
Methylmalonic acid	Baseline	Methylmalonic acid will be measured from venous blood samples
Folic acid status	Baseline	Folic acid will be measured from venous blood samples
Vitamin B2 status	Baseline	Vitamin B2 will be measured from venous blood samples
Zinc status	Baseline	Zinc status will be determined from venous blood samples
Selenoprotein-P status	Baseline	Selenoprotein-P status will be determined from venous blood samples
Creatinine concentration	Baseline	Creatinine will be determined from venous blood samples
Uric acid concentration	Baseline	Uric acid will be determined from venous blood samples
Urea concentration	Baseline	Urea will be determined from urine samples samples
Iodine concentration	Baseline	Iodine status will be determined from urine samples
Potassium concentration	Baseline	Potassium status will be determined from urine samples
Sodium concentration	Baseline	Sodium status will be determined from urine samples
Vitamin C status	Baseline	Vitamin C will be measured from venous blood samples
Magnesium status	Baseline	Magnesium status will be determined from venous blood samples
Hemoglobin concentration	Baseline	Hemoglobin will be determined from venous blood samples
Calcium concentration	Baseline	Calcium status will be determined from urine samples
Creatinine concentration (urine)	Baseline	Creatinine will be determined from urine samples
C-reactive protein concentration	Baseline	The inflammatory marker hsCRP will be determined from serum
Triglyceride concentration	Baseline	Triglyceride concentration will be determine from venous blood samples
Free fatty acid concentration	Baseline	Free fatty acid concentration will be determine from venous blood samples
Eicosapentanoic acid	Baseline	Eicosapentanoic acid (in % of total FA) will be determine from venous blood samples
Docosahexanoic acid	Baseline	Docosahexanoic acid (in % of total FA) will be determine from venous blood samples
LDL-cholesterol concentration	Baseline	LDL-cholesterol concentration will be determine from venous blood samples
HDL-Cholesterol concentration	Baseline	HDL-Cholesterol concentration will be determine from venous blood samples
Cholesterol concentration	Baseline	Cholesterol concentration will be determine from venous blood samples
Glucose concentration	Baseline	Glucose will be measured from venous blood samples
Well being	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
VEGANScreener	Baseline and day 2	The VEGANScreener assesses diet quality using 29 questions of frequency of consumption of different foods and food groups.
Weight	Baseline	Weight will be measured in kg
Height	Baseline	Height will be measured in m
Waist circumference	Baseline	Waist circumference will be measured in cm
Hip circumference	Baseline	Hip circumference will be measured in cm

Trial Locations

Locations (1)

UZ Gent; 🇧🇪 Ghent, Belgium