CClinicalTrials.gg
Enrolling by invitationNCT05882955PERNUGUpdated Jun 26, 2024

Designing a Mixed-initiative Recipe Recommender App for Vegan and Vegetarian Sub-groups

An interventional study of Recipes consumption and Hydroponic unit in Mobile Applications, sponsored by Universitaire Ziekenhuizen KU Leuven. Enrolling by invitation at 1 site in Belgium. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-26.

Sponsored by Universitaire Ziekenhuizen KU Leuven · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 9 months ago, but the record still lists the study as enrolling by invitation.
  • Registered 5 months after the study started (first participant enrolled Dec 2022, registered May 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Female
01

Study 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 (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.

02

Conditions studied

  • Mobile Applications

Keywords

  • app usage
  • recipe recommender acceptance
03

In context

Lead sponsor

Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 928 studies on the registry; 261 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Healthy menstruating female with regular menstruation cycle over 18 years old.
  2. Has been vegan, vegetarian or other diets that do not include the consumption of meat and fish for at least 1 year.
  3. Willing to remain on a plant-based diet for the duration of the study.
  4. Body Mass Index (BMI) between 18.5 - 40 kg/m2.
  5. Lives in Belgium.
  6. Willing to maintain a hydroponic unit at home and consume plants grown in the hydroponic unit (e.g., parsley, rocket, mizuna).
  7. Access to a smartphone or online platform as well as access to the internet.

Exclusion criteria

Exclusion Criteria

  1. Those who have known allergies to the hydroponically grown salad greens (parsley, rocket, mizuna).
  2. Pescatarian (consumes fish and seafood) and flexitarian (consumes meat intermittently) vegetarian.
  3. Those with abnormal menstruation cycle time periods, \<21 and >40-day
  4. BMI \< 18.5 kg/m2 (underweight) and > 40 kg/m2 (severely obese).
  5. Those diagnosed or undergoing treatment for anaemia.
  6. Currently pregnant or lactating.
  7. Diagnosed medical conditions that may impact the study outcomes will be considered on an individual basis.
  8. 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).
  9. Unable to give written or verbal informed consent.
  10. Participating in another dietary intervention study nor given blood in another dietary study in the last 3 months.
  11. Any person related to or living with any member of the study team.
  12. Those who are part of the Line Manager/supervisory structure of the Chief Investigator.
  13. 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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
52 participants (estimated)

Study arms

  • Experimental
    Dietary app 1

    Dietary app recommends high iron or iron focused recipes

    Behavioral: Recipes consumption · Behavioral: Hydroponic unit

  • Sham comparator
    Dietary app 2

    Dietary app recommends standard iron recipes

    Behavioral: Recipes consumption · Behavioral: Hydroponic unit

  • Experimental
    Hydroponic unit 1

    Growing vitamin B12 biofortified plants in a hydroponic unit

    Behavioral: Recipes consumption · Behavioral: Hydroponic unit

  • No intervention
    Hydroponic unit 2

    No hydroponic unit given to participants

Interventions

  • BehavioralRecipes consumption

    Participants will eat one or two recipes a day for 17 weeks

  • BehavioralHydroponic unit

    Participants will grow vitamin B12 biofortified plants for 17 weeks and consume (10 grams) of plant material for 11 weeks.

06

What researchers measure

Primary outcomes

  1. Change in serum ferritin after the dietary app intervention

    Comparison of serum ferritin at baseline and after the intervention

    Time frame: Week: 0, 6/7 and 17

  2. Change of serum B12 after the hydroponic unit intervention

    Comparison of serum B12 at baseline and after the intervention

    Time frame: Week: 6/7 and 17

Secondary outcomes

  1. App usability rating

    The usability of the mobile application will be scored on 100 using the System Usability Scale

    Time frame: Week: 6/7 and 17

  2. 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.

    Time frame: Week: 6/7 and 17

  3. Recipe recommendation performance

    The performance of the recipe recommendation system will be measured using the RESQUE questionnaire on a scale of 1 to 5.

    Time frame: Week: 17

07

Study locations

1 site
  • Departement Computerwetenschappen
    Leuven, Vlaams-Brabant 3001, Belgium
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05882955
Lead sponsor
Universitaire Ziekenhuizen KU Leuven
Responsible party
Sponsor
First posted
May 31, 2023
Start date
Dec 1, 2022
Primary completion
Dec 31, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Jun 26, 2024

Study contacts

Katrien Verbert
principal investigator · KU Leuven

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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