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CompletedNCT06032234VEGANScreenerUpdated Dec 3, 2024

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

An observational study in Healthy, sponsored by Isabelle Herter-Aeberli. Completed at 1 site in Switzerland. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-03.

Sponsored by Isabelle Herter-Aeberli · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
89
Ages
18 Years to 65 Years
Sex
All
01

Study 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, SES 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.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Isabelle Herter-Aeberli is the lead sponsor of 13 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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. >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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
89 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Omnivorous

    Participants following an omniviours diet

    Other: This is an observational study

  • Vegan

    Participants following a vegan diet

    Other: This is an observational study

Interventions

  • OtherThis is an observational study

    This is an observational study

06

What researchers measure

Primary outcomes

  1. Validity of the vegan screener

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

    Time frame: Baseline

Secondary outcomes

  1. Dietary intake

    Dietary intake will be assessed using a weighed food record

    Time frame: Baseline

  2. Food habits

    Food habits will be assessed using a food frequency questionnaire

    Time frame: Baseline

  3. Vitamin D status

    Vitamin D status will be measured from venous blood samples

    Time frame: Baseline

  4. Homocysteine status

    Homocysteine will be measured from venous blood samples

    Time frame: Baseline

  5. holo-transcobalamin

    holo-transcobalamin will be measured from venous blood samples

    Time frame: Baseline

  6. Methoylmalonic acid

    Methoylmalonic acid will be measured from venous blood samples

    Time frame: Baseline

  7. Vitamin B2 status

    Vitamin B2 will be measured from venous blood samples

    Time frame: Baseline

  8. Vitamin C status

    Vitamin C will be measured from venous blood samples

    Time frame: Baseline

  9. Folic acid status

    Folic acid will be measured from venous blood samples

    Time frame: Baseline

  10. Magnesium status

    Magnesium status will be determined from venous blood samples

    Time frame: Baseline

  11. Zinc status

    Zinc status will be determined from venous blood samples

    Time frame: Baseline

  12. Selenoprotein-P status

    Selenoprotein-P status will be determined from venous blood samples

    Time frame: Baseline

  13. Ferritin concentration

    Ferritin concentration will be determined from venous blood samples

    Time frame: Baseline

  14. Soluble transferrin receptor concentration

    Soluble transferrin receptor will be determined from venous blood samples

    Time frame: Baseline

  15. Hemoglobin concentration

    Hemoglobin will be determined from venous blood samples

    Time frame: Baseline

  16. Creatinine concentration

    Creatinine will be determined from venous blood samples

    Time frame: Baseline

  17. Uric acid concentration

    Uric acid will be determined from venous blood samples

    Time frame: Baseline

  18. Urea concentration

    Urea will be determined from urine samples samples

    Time frame: Baseline

  19. Iodine concentration

    Iodine status will be determined from urine samples samples

    Time frame: Baseline

  20. Potassium concentration

    Potassium status will be determined from urine samples samples iodine, potassium, sodium, calcium, creatinine)

    Time frame: Baseline

  21. Sodium concentration

    Sodium status will be determined from urine samples samples

    Time frame: Baseline

  22. Calcium concentration

    Calcium status will be determined from urine samples samples i

    Time frame: Baseline

  23. Creatinine concentration

    Creatinine will be determined from urine samples samples

    Time frame: Baseline

  24. C-reactive protein concentration

    The inflammatory marker hsCRP will be determined from serum

    Time frame: Baseline

  25. Triglyceride concentration

    Triglyceride concentration will be determine from venous blood samples

    Time frame: Baseline

  26. Free fatty acid concentration

    Free fatty acid concentration will be determine from venous blood samples (

    Time frame: Baseline

  27. Eicosapentanoic acid

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

    Time frame: Baseline

  28. Docosahexanoic acid

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

    Time frame: Baseline

  29. LDL-cholesterol concentration

    LDL-cholesterol concentration will be determine from venous blood samples

    Time frame: Baseline

  30. HDL-Cholesterol concentration

    HDL-Cholesterol concentration will be determine from venous blood samples

    Time frame: Baseline

  31. Cholesterol concentration

    Cholesterol concentration will be determine from venous blood samples

    Time frame: Baseline

  32. Glucose concentration

    Glucose will be measured from venous blood samples

    Time frame: Baseline

  33. Well being questionnaire

    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

    Time frame: Baseline

  34. VEGANScreener

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

    Time frame: Baseline and day 2

  35. Weight

    Weight will be measured in kg

    Time frame: Baseline

  36. Height

    Height will be measured in m

    Time frame: Baseline

  37. Waist circumference

    Waist circumference will be measured in cm

    Time frame: Baseline

  38. Hip circumference

    Hip circumference will be measured in cm

    Time frame: Baseline

Other outcomes

  1. International Physical Activity Questionnaire iPAQ

    Physical activity will be assessed using a questionnaire using the iPAQ

    Time frame: Baseline

  2. Blood pressure

    Systolic and diastolic blood pressure will be measured

    Time frame: Baseline

  3. Heart rate

    Heart rate will be measured

    Time frame: Baseline

07

Study locations

1 site
  • ETH Zurich
    Zurich, 8092, Switzerland
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2023 to primary completion in Mar 2024, 6 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 25, 2023
First posted
Sep 11, 2023
StartActual
Sep 12, 2023
Primary completionActual
Mar 30, 2024
CompletionActual
Jul 31, 2024
Last update
Dec 3, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06032234
Lead sponsor
Isabelle Herter-Aeberli
Collaborators
Berner Fachhochschule
Responsible party
Isabelle Herter-Aeberli (Principle Investigator, Swiss Federal Institute of Technology) — Sponsor-investigator
First posted
Sep 11, 2023
Start date
Sep 12, 2023
Primary completion
Mar 30, 2024
Completion
Jul 31, 2024
Last update
Dec 3, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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