NCT05882955

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 31, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

June 26, 2024

Status Verified

June 1, 2024

Enrollment Period

2.1 years

First QC Date

May 12, 2023

Last Update Submit

June 25, 2024

Conditions

Keywords

app usagerecipe recommender acceptance

Outcome Measures

Primary Outcomes (2)

  • Change in serum ferritin after the dietary app intervention

    Comparison of serum ferritin at baseline and after the intervention

    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

    Week: 6/7 and 17

Secondary Outcomes (3)

  • App usability rating

    Week: 6/7 and 17

  • Score on the Unified Theory of Acceptance and Use of Technology questionnaire

    Week: 6/7 and 17

  • Recipe recommendation performance

    Week: 17

Study Arms (4)

Dietary app 1

EXPERIMENTAL

Dietary app recommends high iron or iron focused recipes

Behavioral: Recipes consumptionBehavioral: Hydroponic unit

Dietary app 2

SHAM COMPARATOR

Dietary app recommends standard iron recipes

Behavioral: Recipes consumptionBehavioral: Hydroponic unit

Hydroponic unit 1

EXPERIMENTAL

Growing vitamin B12 biofortified plants in a hydroponic unit

Behavioral: Recipes consumptionBehavioral: Hydroponic unit

Hydroponic unit 2

NO INTERVENTION

No hydroponic unit given to participants

Interventions

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

Dietary app 1Dietary app 2Hydroponic unit 1
Hydroponic unitBEHAVIORAL

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

Dietary app 1Dietary app 2Hydroponic unit 1

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departement Computerwetenschappen

Leuven, Vlaams-Brabant, 3001, Belgium

Location

Study Officials

  • Katrien Verbert

    KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2023

First Posted

May 31, 2023

Study Start

December 1, 2022

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

June 26, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations