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

Healthy Clinical Trial

— VEGANScreener  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06032234
• Other study ID #: VEGANScreenerCH
• Status: Recruiting
• Start date: September 12, 2023
• Est. completion date: May 30, 2024

Study information

• Verified date: April 2024
• Source: Swiss Federal Institute of Technology
• Contact: Isabelle Herter, PhD
• Phone: +41446327481
• Email: isabelle.herter[@]hest.ethz.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 89
• Est. completion date: May 30, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
Switzerland	ETH Zurich	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
Isabelle Herter-Aeberli	Berner Fachhochschule

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	International Physical Activity Questionnaire iPAQ	Physical activity will be assessed using a questionnaire using the iPAQ	Baseline
Other	Blood pressure	Systolic and diastolic blood pressure will be measured	Baseline
Other	Heart rate	Heart rate will be measured	Baseline
Primary	Validity of the vegan screener	The validity will be assessed by calculating associations between the screener and reference method.	Baseline
Secondary	Dietary intake	Dietary intake will be assessed using a weighed food record	Baseline
Secondary	Food habits	Food habits will be assessed using a food frequency questionnaire	Baseline
Secondary	Vitamin D status	Vitamin D status will be measured from venous blood samples	Baseline
Secondary	Homocysteine status	Homocysteine will be measured from venous blood samples	Baseline
Secondary	holo-transcobalamin	holo-transcobalamin will be measured from venous blood samples	Baseline
Secondary	Methoylmalonic acid	Methoylmalonic acid will be measured from venous blood samples	Baseline
Secondary	Vitamin B2 status	Vitamin B2 will be measured from venous blood samples	Baseline
Secondary	Vitamin C status	Vitamin C will be measured from venous blood samples	Baseline
Secondary	Folic acid status	Folic acid will be measured from venous blood samples	Baseline
Secondary	Magnesium status	Magnesium status will be determined from venous blood samples	Baseline
Secondary	Zinc status	Zinc status will be determined from venous blood samples	Baseline
Secondary	Selenoprotein-P status	Selenoprotein-P status will be determined from venous blood samples	Baseline
Secondary	Ferritin concentration	Ferritin concentration will be determined from venous blood samples	Baseline
Secondary	Soluble transferrin receptor concentration	Soluble transferrin receptor will be determined from venous blood samples	Baseline
Secondary	Hemoglobin concentration	Hemoglobin will be determined from venous blood samples	Baseline
Secondary	Creatinine concentration	Creatinine will be determined from venous blood samples	Baseline
Secondary	Uric acid concentration	Uric acid will be determined from venous blood samples	Baseline
Secondary	Urea concentration	Urea will be determined from urine samples samples	Baseline
Secondary	Iodine concentration	Iodine status will be determined from urine samples samples	Baseline
Secondary	Potassium concentration	Potassium status will be determined from urine samples samples iodine, potassium, sodium, calcium, creatinine)	Baseline
Secondary	Sodium concentration	Sodium status will be determined from urine samples samples	Baseline
Secondary	Calcium concentration	Calcium status will be determined from urine samples samples i	Baseline
Secondary	Creatinine concentration	Creatinine will be determined from urine samples samples	Baseline
Secondary	C-reactive protein concentration	The inflammatory marker hsCRP will be determined from serum	Baseline
Secondary	Triglyceride concentration	Triglyceride concentration will be determine from venous blood samples	Baseline
Secondary	Free fatty acid concentration	Free fatty acid concentration will be determine from venous blood samples (	Baseline
Secondary	Eicosapentanoic acid	Eicosapentanoic acid (in % of total FA) will be determine from venous blood samples	Baseline
Secondary	Docosahexanoic acid	Docosahexanoic acid (in % of total FA) will be determine from venous blood samples	Baseline
Secondary	LDL-cholesterol concentration	LDL-cholesterol concentration will be determine from venous blood samples	Baseline
Secondary	HDL-Cholesterol concentration	HDL-Cholesterol concentration will be determine from venous blood samples	Baseline
Secondary	Cholesterol concentration	Cholesterol concentration will be determine from venous blood samples	Baseline
Secondary	Glucose concentration	Glucose will be measured from venous blood samples	Baseline
Secondary	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	Baseline
Secondary	VEGANScreener	The VEGANScreener assesses diet quality using 29 questions of frequency of consumption of different foods and food groups.	Baseline and day 2
Secondary	Weight	Weight will be measured in kg	Baseline
Secondary	Height	Height will be measured in m	Baseline
Secondary	Waist circumference	Waist circumference will be measured in cm	Baseline
Secondary	Hip circumference	Hip circumference will be measured in cm	Baseline