HealthyVEGANScreenerNCT06032234
Development and Evaluation of a Web-based Diet Quality Screener for Vegans (VEGANScreener)
An observational study of Healthy, run by Isabelle Herter-Aeberli at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- This is an observational study
- How many people
- 89 participants
- Where
- 1 siteSwitzerland
- Study dates
- 12 Sep 2023to 31 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy participants following a vegan or omnivours diet (ratio 1:1).
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Healthy
- Being tested
- This is an observational study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This is an observational studyOther
This is an observational study
| Study group | Role | What they receive |
|---|---|---|
| Omnivorous | Participants following an omniviours diet Receives: Other: This is an observational study | |
| Vegan | Participants following a vegan diet Receives: Other: This is an observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validity of the vegan screener
The validity will be assessed by calculating associations between the screener and reference method.
Measured: Baseline
Secondary outcomes (38)
Dietary intake
Dietary intake will be assessed using a weighed food record
Measured: Baseline
Food habits
Food habits will be assessed using a food frequency questionnaire
Measured: Baseline
Vitamin D status
Vitamin D status will be measured from venous blood samples
Measured: Baseline
Homocysteine status
Homocysteine will be measured from venous blood samples
Measured: Baseline
holo-transcobalamin
holo-transcobalamin will be measured from venous blood samples
Measured: Baseline
Methoylmalonic acid
Methoylmalonic acid will be measured from venous blood samples
Measured: Baseline
Vitamin B2 status
Vitamin B2 will be measured from venous blood samples
Measured: Baseline
Vitamin C status
Vitamin C will be measured from venous blood samples
Measured: Baseline
Folic acid status
Folic acid will be measured from venous blood samples
Measured: Baseline
Magnesium status
Magnesium status will be determined from venous blood samples
Measured: Baseline
Zinc status
Zinc status will be determined from venous blood samples
Measured: Baseline
Selenoprotein-P status
Selenoprotein-P status will be determined from venous blood samples
Measured: Baseline
Ferritin concentration
Ferritin concentration will be determined from venous blood samples
Measured: Baseline
Soluble transferrin receptor concentration
Soluble transferrin receptor will be determined from venous blood samples
Measured: Baseline
Hemoglobin concentration
Hemoglobin will be determined from venous blood samples
Measured: Baseline
Creatinine concentration
Creatinine will be determined from venous blood samples
Measured: Baseline
Uric acid concentration
Uric acid will be determined from venous blood samples
Measured: Baseline
Urea concentration
Urea will be determined from urine samples samples
Measured: Baseline
Iodine concentration
Iodine status will be determined from urine samples samples
Measured: Baseline
Potassium concentration
Potassium status will be determined from urine samples samples iodine, potassium, sodium, calcium, creatinine)
Measured: Baseline
Sodium concentration
Sodium status will be determined from urine samples samples
Measured: Baseline
Calcium concentration
Calcium status will be determined from urine samples samples i
Measured: Baseline
Creatinine concentration
Creatinine will be determined from urine samples samples
Measured: Baseline
C-reactive protein concentration
The inflammatory marker hsCRP will be determined from serum
Measured: Baseline
Triglyceride concentration
Triglyceride concentration will be determine from venous blood samples
Measured: Baseline
Free fatty acid concentration
Free fatty acid concentration will be determine from venous blood samples (
Measured: Baseline
Eicosapentanoic acid
Eicosapentanoic acid (in % of total FA) will be determine from venous blood samples
Measured: Baseline
Docosahexanoic acid
Docosahexanoic acid (in % of total FA) will be determine from venous blood samples
Measured: Baseline
LDL-cholesterol concentration
LDL-cholesterol concentration will be determine from venous blood samples
Measured: Baseline
HDL-Cholesterol concentration
HDL-Cholesterol concentration will be determine from venous blood samples
Measured: Baseline
Cholesterol concentration
Cholesterol concentration will be determine from venous blood samples
Measured: Baseline
Glucose concentration
Glucose will be measured from venous blood samples
Measured: Baseline
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
Measured: Baseline
VEGANScreener
The VEGANScreener assesses diet quality using 29 questions of frequency of consumption of different foods and food groups.
Measured: Baseline and day 2
Weight
Weight will be measured in kg
Measured: Baseline
Height
Height will be measured in m
Measured: Baseline
Waist circumference
Waist circumference will be measured in cm
Measured: Baseline
Hip circumference
Hip circumference will be measured in cm
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start12 Sep 2023
- Primary completion30 Mar 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isabelle Herter-Aeberli
- Sponsor type
- University, hospital or other
- Collaborators
- Bern University of Applied Sciences
- Responsible party
- Sponsor-investigator, Isabelle Herter-Aeberli, Swiss Federal Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06032234
- Sponsor's protocol ID
- VEGANScreenerCH
- Acronym
- VEGANScreener
- Status last verified
- Oct 2024
- First submitted
- 25 Aug 2023
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of a Web-based Diet Quality Screener for Vegans (VEGANScreener)
- ClinicalTrials.gov ID
- NCT06032234
- Acronym / sponsor ID
- VEGANScreener / VEGANScreenerCH
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Isabelle Herter-AeberliUniversity, hospital or other
- Collaborators
- Bern University of Applied Sciences
- Study start
- 12 Sep 2023 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 11 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omnivorous | – | Other: This is an observational studyParticipants following an omniviours diet |
| Vegan | – | Other: This is an observational studyParticipants following a vegan diet |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy participants following a vegan or omnivours diet (ratio 1:1).
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This is an observational studyThis is an observational study | Other | Omnivorous, Vegan |
Primary outcome
Validity of the vegan screener
Time frame: Baseline
The validity will be assessed by calculating associations between the screener and reference method.
38 secondary outcomes
Dietary intake
Time frame: Baseline
Food habits
Time frame: Baseline
Vitamin D status
Time frame: Baseline
Homocysteine status
Time frame: Baseline
holo-transcobalamin
Time frame: Baseline
Methoylmalonic acid
Time frame: Baseline
Vitamin B2 status
Time frame: Baseline
Vitamin C status
Time frame: Baseline
Folic acid status
Time frame: Baseline
Magnesium status
Time frame: Baseline
Zinc status
Time frame: Baseline
Selenoprotein-P status
Time frame: Baseline
Ferritin concentration
Time frame: Baseline
Soluble transferrin receptor concentration
Time frame: Baseline
Hemoglobin concentration
Time frame: Baseline
Creatinine concentration
Time frame: Baseline
Uric acid concentration
Time frame: Baseline
Urea concentration
Time frame: Baseline
Iodine concentration
Time frame: Baseline
Potassium concentration
Time frame: Baseline
Sodium concentration
Time frame: Baseline
Calcium concentration
Time frame: Baseline
Creatinine concentration
Time frame: Baseline
C-reactive protein concentration
Time frame: Baseline
Triglyceride concentration
Time frame: Baseline
Free fatty acid concentration
Time frame: Baseline
Eicosapentanoic acid
Time frame: Baseline
Docosahexanoic acid
Time frame: Baseline
LDL-cholesterol concentration
Time frame: Baseline
HDL-Cholesterol concentration
Time frame: Baseline
Cholesterol concentration
Time frame: Baseline
Glucose concentration
Time frame: Baseline
Well being questionnaire
Time frame: Baseline
VEGANScreener
Time frame: Baseline and day 2
Weight
Time frame: Baseline
Height
Time frame: Baseline
Waist circumference
Time frame: Baseline
Hip circumference
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Isabelle Herter-Aeberli at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validity of the vegan screener (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024.