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

Sponsor
Isabelle Herter-Aeberli (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06032234
Collaborator
Berner Fachhochschule (Other)
100
7.6

Study Details

Study Description

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, 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.

Condition or Disease Intervention/Treatment Phase
  • Other: This is an observational study

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Development and Evaluation of a Web-based Diet Quality Screener for Vegans (VEGANScreener)
Anticipated Study Start Date :
Sep 12, 2023
Anticipated Primary Completion Date :
Feb 29, 2024
Anticipated Study Completion Date :
Apr 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Omnivorous

Participants following an omniviours diet

Other: This is an observational study
This is an observational study

Vegan

Participants following a vegan diet

Other: This is an observational study
This is an observational study

Outcome Measures

Primary Outcome Measures

  1. Validity of the vegan screener [Baseline]

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

Secondary Outcome Measures

  1. Dietary intake [Baseline]

    Dietary intake will be assessed using a weighed food record

  2. Food habits [Baseline]

    Food habits will be assessed using a food frequency questionnaire

  3. Vitamin D status [Baseline]

    Vitamin D status will be measured from venous blood samples

  4. Homocysteine status [Baseline]

    Homocysteine will be measured from venous blood samples

  5. holo-transcobalamin [Baseline]

    holo-transcobalamin will be measured from venous blood samples

  6. Methoylmalonic acid [Baseline]

    Methoylmalonic acid will be measured from venous blood samples

  7. Vitamin B2 status [Baseline]

    Vitamin B2 will be measured from venous blood samples

  8. Vitamin C status [Baseline]

    Vitamin C will be measured from venous blood samples

  9. Folic acid status [Baseline]

    Folic acid will be measured from venous blood samples

  10. Magnesium status [Baseline]

    Magnesium status will be determined from venous blood samples

  11. Zinc status [Baseline]

    Zinc status will be determined from venous blood samples

  12. Selenoprotein-P status [Baseline]

    Selenoprotein-P status will be determined from venous blood samples

  13. Ferritin concentration [Baseline]

    Ferritin concentration will be determined from venous blood samples

  14. Soluble transferrin receptor concentration [Baseline]

    Soluble transferrin receptor will be determined from venous blood samples

  15. Hemoglobin concentration [Baseline]

    Hemoglobin will be determined from venous blood samples

  16. Creatinine concentration [Baseline]

    Creatinine will be determined from venous blood samples

  17. Uric acid concentration [Baseline]

    Uric acid will be determined from venous blood samples

  18. Urea concentration [Baseline]

    Urea will be determined from urine samples samples

  19. Iodine concentration [Baseline]

    Iodine status will be determined from urine samples samples

  20. Potassium concentration [Baseline]

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

  21. Sodium concentration [Baseline]

    Sodium status will be determined from urine samples samples

  22. Calcium concentration [Baseline]

    Calcium status will be determined from urine samples samples i

  23. Creatinine concentration [Baseline]

    Creatinine will be determined from urine samples samples

  24. C-reactive protein concentration [Baseline]

    The inflammatory marker hsCRP will be determined from serum

  25. Triglyceride concentration [Baseline]

    Triglyceride concentration will be determine from venous blood samples

  26. Free fatty acid concentration [Baseline]

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

  27. Eicosapentanoic acid [Baseline]

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

  28. Docosahexanoic acid [Baseline]

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

  29. LDL-cholesterol concentration [Baseline]

    LDL-cholesterol concentration will be determine from venous blood samples

  30. HDL-Cholesterol concentration [Baseline]

    HDL-Cholesterol concentration will be determine from venous blood samples

  31. Cholesterol concentration [Baseline]

    Cholesterol concentration will be determine from venous blood samples

  32. Glucose concentration [Baseline]

    Glucose will be measured from venous blood samples

  33. Well being questionnaire [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 [Baseline and day 2]

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

  35. Weight [Baseline]

    Weight will be measured in kg

  36. Height [Baseline]

    Height will be measured in m

  37. Waist circumference [Baseline]

    Waist circumference will be measured in cm

  38. Hip circumference [Baseline]

    Hip circumference will be measured in cm

Other Outcome Measures

  1. International Physical Activity Questionnaire iPAQ [Baseline]

    Physical activity will be assessed using a questionnaire using the iPAQ

  2. Blood pressure [Baseline]

    Systolic and diastolic blood pressure will be measured

  3. Heart rate [Baseline]

    Heart rate will be measured

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Isabelle Herter-Aeberli
  • Berner Fachhochschule

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Isabelle Herter-Aeberli, Principle Investigator, Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier:
NCT06032234
Other Study ID Numbers:
  • VEGANScreenerCH
First Posted:
Sep 11, 2023
Last Update Posted:
Sep 11, 2023
Last Verified:
Sep 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Sep 11, 2023