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Clinical Trials/NCT06032234
NCT06032234
Completed
Not Applicable

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

Isabelle Herter-Aeberli1 site in 1 country89 target enrollmentSeptember 12, 2023
ConditionsHealthy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy
Sponsor
Isabelle Herter-Aeberli
Enrollment
89
Locations
1
Primary Endpoint
Validity of the vegan screener
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 12, 2023
End Date
July 31, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Isabelle Herter-Aeberli
Responsible Party
Sponsor Investigator
Principal Investigator

Isabelle Herter-Aeberli

Principle Investigator

Swiss Federal Institute of Technology

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Validity of the vegan screener

Time Frame: Baseline

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

Secondary Outcomes

  • Dietary intake(Baseline)
  • Vitamin D status(Baseline)
  • Potassium concentration(Baseline)
  • Eicosapentanoic acid(Baseline)
  • holo-transcobalamin(Baseline)
  • Vitamin B2 status(Baseline)
  • Vitamin C status(Baseline)
  • Calcium concentration(Baseline)
  • C-reactive protein concentration(Baseline)
  • Free fatty acid concentration(Baseline)
  • Height(Baseline)
  • Waist circumference(Baseline)
  • Hip circumference(Baseline)
  • Homocysteine status(Baseline)
  • Folic acid status(Baseline)
  • Ferritin concentration(Baseline)
  • Hemoglobin concentration(Baseline)
  • Uric acid concentration(Baseline)
  • LDL-cholesterol concentration(Baseline)
  • HDL-Cholesterol concentration(Baseline)
  • VEGANScreener(Baseline and day 2)
  • Food habits(Baseline)
  • Methoylmalonic acid(Baseline)
  • Zinc status(Baseline)
  • Selenoprotein-P status(Baseline)
  • Soluble transferrin receptor concentration(Baseline)
  • Triglyceride concentration(Baseline)
  • Cholesterol concentration(Baseline)
  • Magnesium status(Baseline)
  • Creatinine concentration(Baseline)
  • Urea concentration(Baseline)
  • Iodine concentration(Baseline)
  • Sodium concentration(Baseline)
  • Well being questionnaire(Baseline)
  • Docosahexanoic acid(Baseline)
  • Glucose concentration(Baseline)
  • Weight(Baseline)

Study Sites (1)

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