Mobile ApplicationsPERNUGNCT05882955
Designing a Mixed-initiative Recipe Recommender App for Vegan and Vegetarian Sub-groups
A study testing Recipes consumption and Hydroponic unit in people with Mobile Applications, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
The goal of this study is to test the usability and applicability of a mobile application which recommends recipes. We will recruit up to 52 vegan/vegetarian participants in Belgium, and provide them with an iDOO hydroponic plant growing unit… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mobile Applications
- What is being tested?
- Recipes consumption and Hydroponic unit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Dec 2022to 31 Dec 2024
- Phase
- Interventional
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy menstruating female with regular menstruation cycle over 18 years old.
- Has been vegan, vegetarian or other diets that do not include the consumption of meat and fish for at least 1 year.
- Willing to remain on a plant-based diet for the duration of the study.
- Body Mass Index (BMI) between 18.5 - 40 kg/m2.
- Lives in Belgium.
- Willing to maintain a hydroponic unit at home and consume plants grown in the hydroponic unit (e.g., parsley, rocket, mizuna).
- Access to a smartphone or online platform as well as access to the internet.
Who cannot join
- Those who have known allergies to the hydroponically grown salad greens (parsley, rocket, mizuna).
- Pescatarian (consumes fish and seafood) and flexitarian (consumes meat intermittently) vegetarian.
- Those with abnormal menstruation cycle time periods, <21 and >40-day
- BMI < 18.5 kg/m2 (underweight) and > 40 kg/m2 (severely obese).
- Those diagnosed or undergoing treatment for anaemia.
- Currently pregnant or lactating.
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- Diagnosed medical conditions that may impact the study outcomes will be considered on an individual basis.
- On a, or about to start, a diet programme such as the 5:2 programme (5:2 programme is where an individual would eat normally for five days a week, and fast for two days a week by reducing calorie consumption).
- Unable to give written or verbal informed consent.
- Participating in another dietary intervention study nor given blood in another dietary study in the last 3 months.
- Any person related to or living with any member of the study team.
- Those who are part of the Line Manager/supervisory structure of the Chief Investigator.
- Those who have been asked to self-isolate or have been diagnosed with COVID-19 in the last 14 days. However, participants can be rescreened 7 days after the isolation period.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this study is to test the usability and applicability of a mobile application which recommends recipes. We will recruit up to 52 vegan/vegetarian participants in Belgium, and provide them with an iDOO hydroponic plant growing unit (https://www.idooworld.com/products/idoo-20pods-indoor-herb-garden-kit-hydroponics-growing-system-with-led-grow-light) as well as seeds and plant nutrients to grow certain herbs at home. Over a period of 17 weeks, participants will be asked to consume plants from the unit by following the recipes recommended by the app. The participants will then observe changes in their iron and vitamin B12 levels by following up with their GP and report the outcomes back to the researchers at three points during the study (week 0, week 6, and week 17). In addition, the participants will evaluate the usability of the app and the recipes recommended by the app.
Read the detailed description
Iron is present in plant and animal-derived foods but the fractional absorption of iron from plant foods (that is the percent of iron absorbed from a consumed quantity) is often low (approx 10%) compared to iron from animal sources 25%-30%. It is therefore more challenging for vegans and vegetarians to achieve the Reference Nutrient Intake (RNI) for iron (8.7 mg/day for men over 18 and women over 50, 14.8 mg/day for women aged 18-50), and they are likely to absorb less of that iron and therefore are more likely to become iron depleted.
Plants do not synthesise vitamin B12 and unless fortified, plant-derived foods and beverages do not contain any vitamin B12. the RNI for vitamin B12 in the UK is 1.5 µg/day, therefore it is crucial that vegans and vegetarians take B12 supplements if they don't consume B12-fortified foods or find other ways of incorporating this vitamin into their diets.
Over a period of 17 weeks, participants will be asked to consume plants from the unit by following the recipes recommended by the app. The participants will then observe changes in their iron and vitamin B12 levels by following up with their GP and report the outcomes back to the researchers at three points during the study (week 0, week 6, and week 17). In addition, the participants will evaluate the usability of the app and the recipes recommended by the app.
- Conditions
- Mobile Applications
- Being tested
- Recipes consumption, Hydroponic unit
- Keywords
- app usage, recipe recommender acceptance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recipes consumptionBehavioural
Participants will eat one or two recipes a day for 17 weeks
Hydroponic unitBehavioural
Participants will grow vitamin B12 biofortified plants for 17 weeks and consume (10 grams) of plant material for 11 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Dietary app 1 | Experimental | Dietary app recommends high iron or iron focused recipes Receives: Behavioral: Recipes consumption; Behavioral: Hydroponic unit |
| Dietary app 2 | Sham comparator | Dietary app recommends standard iron recipes Receives: Behavioral: Recipes consumption; Behavioral: Hydroponic unit |
| Hydroponic unit 1 | Experimental | Growing vitamin B12 biofortified plants in a hydroponic unit Receives: Behavioral: Recipes consumption; Behavioral: Hydroponic unit |
| Hydroponic unit 2 | No intervention | No hydroponic unit given to participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum ferritin after the dietary app intervention
Comparison of serum ferritin at baseline and after the intervention
Measured: Week: 0, 6/7 and 17
Change of serum B12 after the hydroponic unit intervention
Comparison of serum B12 at baseline and after the intervention
Measured: Week: 6/7 and 17
Secondary outcomes (3)
App usability rating
The usability of the mobile application will be scored on 100 using the System Usability Scale
Measured: Week: 6/7 and 17
Score on the Unified Theory of Acceptance and Use of Technology questionnaire
The acceptance of the mobile application will be measured using the Unified Theory of Acceptance and Use of Technology questionnaire on a scale of 1 to 5.
Measured: Week: 6/7 and 17
Recipe recommendation performance
The performance of the recipe recommendation system will be measured using the RESQUE questionnaire on a scale of 1 to 5.
Measured: Week: 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start1 Dec 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mobile ApplicationsStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katrien Verbert, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05882955
- Sponsor's protocol ID
- G-2021-4203-R5(AMD)
- Acronym
- PERNUG
- Status last verified
- Jun 2024
- First submitted
- 12 May 2023
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Designing a Mixed-initiative Recipe Recommender App for Vegan and Vegetarian Sub-groups
- ClinicalTrials.gov ID
- NCT05882955
- Acronym / sponsor ID
- PERNUG / G-2021-4203-R5(AMD)
- Conditions
- Mobile Applications
- Keywords
- app usage, recipe recommender acceptance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 31 May 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 goal of this study is to test the usability and applicability of a mobile application which recommends recipes. We will recruit up to 52 vegan/vegetarian participants in Belgium, and provide them with an iDOO hydroponic plant growing unit (https://www.idooworld.com/products/idoo-20pods-indoor-herb-garden-kit-hydroponics-growing-system-with-led-grow-light) as well as seeds and plant nutrients to grow certain herbs at home. Over a period of 17 weeks, participants will be asked to consume plants from the unit by following the recipes recommended by the app. The participants will then observe changes in their iron and vitamin B12 levels by following up with their GP and report the outcomes back to the researchers at three points during the study (week 0, week 6, and week 17). In addition, the participants will evaluate the usability of the app and the recipes recommended by the app.
Detailed description
Iron is present in plant and animal-derived foods but the fractional absorption of iron from plant foods (that is the percent of iron absorbed from a consumed quantity) is often low (approx 10%) compared to iron from animal sources 25%-30%. It is therefore more challenging for vegans and vegetarians to achieve the Reference Nutrient Intake (RNI) for iron (8.7 mg/day for men over 18 and women over 50, 14.8 mg/day for women aged 18-50), and they are likely to absorb less of that iron and therefore are more likely to become iron depleted.
Plants do not synthesise vitamin B12 and unless fortified, plant-derived foods and beverages do not contain any vitamin B12. the RNI for vitamin B12 in the UK is 1.5 µg/day, therefore it is crucial that vegans and vegetarians take B12 supplements if they don't consume B12-fortified foods or find other ways of incorporating this vitamin into their diets.
Over a period of 17 weeks, participants will be asked to consume plants from the unit by following the recipes recommended by the app. The participants will then observe changes in their iron and vitamin B12 levels by following up with their GP and report the outcomes back to the researchers at three points during the study (week 0, week 6, and week 17). In addition, the participants will evaluate the usability of the app and the recipes recommended by the app.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dietary app 1 | Experimental | Behavioral: Recipes consumption, Behavioral: Hydroponic unitDietary app recommends high iron or iron focused recipes |
| Dietary app 2 | Sham comparator | Behavioral: Recipes consumption, Behavioral: Hydroponic unitDietary app recommends standard iron recipes |
| Hydroponic unit 1 | Experimental | Behavioral: Recipes consumption, Behavioral: Hydroponic unitGrowing vitamin B12 biofortified plants in a hydroponic unit |
| Hydroponic unit 2 | No intervention | –No hydroponic unit given to participants |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy menstruating female with regular menstruation cycle over 18 years old.
- Has been vegan, vegetarian or other diets that do not include the consumption of meat and fish for at least 1 year.
- Willing to remain on a plant-based diet for the duration of the study.
- Body Mass Index (BMI) between 18.5 - 40 kg/m2.
- Lives in Belgium.
Key exclusion criteria (13 listed)
- Those who have known allergies to the hydroponically grown salad greens (parsley, rocket, mizuna).
- Pescatarian (consumes fish and seafood) and flexitarian (consumes meat intermittently) vegetarian.
- Those with abnormal menstruation cycle time periods, <21 and >40-day
- BMI < 18.5 kg/m2 (underweight) and > 40 kg/m2 (severely obese).
- Those diagnosed or undergoing treatment for anaemia.
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 |
|---|---|---|
| Recipes consumptionParticipants will eat one or two recipes a day for 17 weeks | Behavioural | Dietary app 1, Dietary app 2, Hydroponic unit 1 |
| Hydroponic unitParticipants will grow vitamin B12 biofortified plants for 17 weeks and consume (10 grams) of plant material for 11 weeks. | Behavioural | Dietary app 1, Dietary app 2, Hydroponic unit 1 |
Primary outcome
Change in serum ferritin after the dietary app intervention
Time frame: Week: 0, 6/7 and 17
Comparison of serum ferritin at baseline and after the intervention
Change of serum B12 after the hydroponic unit intervention
Time frame: Week: 6/7 and 17
Comparison of serum B12 at baseline and after the intervention
3 secondary outcomes
App usability rating
Time frame: Week: 6/7 and 17
Score on the Unified Theory of Acceptance and Use of Technology questionnaire
Time frame: Week: 6/7 and 17
Recipe recommendation performance
Time frame: Week: 17
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Individual participant dataSharing planned: No
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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.
Katrien Verbert principal investigator
KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recipes consumption and Hydroponic unit in people with Mobile Applications, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 7 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 26 Jun 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 Belgium. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Change in serum ferritin after the dietary app intervention (time frame: Week: 0, 6/7 and 17). The study lists 2 primary outcomes in all. 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 26 Jun 2024.