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

NCT ID: NCT05882955

Last Updated: 2024-06-26

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2024-12-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Dietary app 1

Dietary app recommends high iron or iron focused recipes

Group Type: EXPERIMENTAL

Recipes consumption

Intervention Type: BEHAVIORAL

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

Hydroponic unit

Intervention Type: BEHAVIORAL

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

Dietary app 2

Dietary app recommends standard iron recipes

Group Type: SHAM_COMPARATOR

Recipes consumption

Intervention Type: BEHAVIORAL

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

Hydroponic unit

Intervention Type: BEHAVIORAL

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

Hydroponic unit 1

Growing vitamin B12 biofortified plants in a hydroponic unit

Group Type: EXPERIMENTAL

Recipes consumption

Intervention Type: BEHAVIORAL

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

Hydroponic unit

Intervention Type: BEHAVIORAL

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

Hydroponic unit 2

No hydroponic unit given to participants

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Recipes consumption

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

Intervention Type: BEHAVIORAL

Hydroponic unit

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Katrien Verbert

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Locations

Departement Computerwetenschappen

Leuven, Vlaams-Brabant, Belgium

Countries

Belgium

Other Identifiers

G-2021-4203-R5(AMD)

Identifier Type: -

Identifier Source: org_study_id