The HARVEST Study
Research type
Research Study
Full title
Hydroponic Fortification and Dietary App Effect on Vitamin B12 and Iron (Fe) Status
IRAS ID
310348
Contact name
Paul Kroon
Contact email
Sponsor organisation
Quadram Institute Bioscience
Duration of Study in the UK
3 years, 1 months, 1 days
Research summary
We propose to undertake an intervention trial in 52 vegan or vegetarian menstruating women aged 18 and over, focusing on their iron status (serum ferritin) and B12 status as the primary outcomes. The intervention will include the use of a dietary app that recommends vegan recipes that contain varying amounts of iron, and an indoor kitchen garden (hydroponic unit) to grow vitamin B12 fortified leafy plants (i.e. parsley, Mizuna, rocket). The iron-focused recipes will be used to determine whether they can improve participants iron levels and vitamin B12 biofortified plants to improve their vitamin B12 nutritional status. We will collect venous blood to test the biomarkers.
We seek approval to undertake This randomised, controlled, double-blinded, parallel dietary intervention study in 52 menstruating vegan or vegetarian women over 18 years who are borderline anaemic (serum ferritin 15 – 40 µg/L). Eligible participants will be randomised either to the iron intervention group or the iron control group. All participants will be allocated to active Vitamin B12 intervention with biofortified salad greens grown in the indoor kitchen garden. However, a small subset of participants (no more than 20) who are keen to participate but do not desire a kitchen garden will be allowed to participate in the app-only intervention.
Participants habitual diet will be assessed through lifestyle questionnaires including a Food Frequency Questionnaire and VAS Fatigue Level Questionnaire. We will also assess participants' interaction with the kitchen garden and the dietary app using the User Feedback Questionnaire and App Usability Questionnaires.REC name
London - City & East Research Ethics Committee
REC reference
22/LO/0578
Date of REC Opinion
29 Sep 2022
REC opinion
Further Information Favourable Opinion