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

U

University Ghent

Status

Active, not recruiting

Conditions

Healthy

Treatments

Other: This is an observational study

Study type

Observational

Funder types

Other

Identifiers

NCT06861205
HOGENT (Other Grant/Funding Number)
G0G5121N (Other Grant/Funding Number)
No. 727565 (Other Grant/Funding Number)
ONZ-2023-0169

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

200 participants in 2 patient groups

Omnivorous
Description:
Participants following an omnivor diet
Treatment:
Other: This is an observational study
Vegan
Description:
Participants following a vegan diet
Treatment:
Other: This is an observational study

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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