Hydroponic Fortification and Dietary App Effect on Nutrients Level (Harvest) (NCT05740462) | Clinical Trial Compass
By InvitationNot Applicable
Hydroponic Fortification and Dietary App Effect on Nutrients Level (Harvest)
United Kingdom52 participantsStarted 2023-05-04
Plain-language summary
Veganism and vegetarianism have clear benefits where they have a lower risk of many health issues. However, they also have a higher risk of nutrients and vitamin deficiency such as iron and vitamin B12. Iron can be found in plant-based food but in varying quantities, whereas vitamin B12 is mainly found in red meat, thus vegans and vegetarians can only take this vitamin in supplements such as tablets. In this study, the investigators are testing two interventions, the consumption of recipes with a certain iron amount to increase iron levels, and the consumption of vitamin B12 biofortified plants to increase serum B12 levels in vegan and vegetarian participants.
Who can participate
Age range18 Years ā 60 Years
SexFEMALE
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Inclusion criteria
ā. Women over 18 years with a regular menstruation cycle (\>21 and \<40 days).
ā. Has followed a vegan or vegetarian diet that does not include the consumption of meat or fish for at least 1 year.
ā. Willing to remain on their background diet for the duration of the study.
ā. Those who are on a routine regimen of iron and/or vitamin B12 supplements must maintain the same doses 3 month prior to the study and during the duration of the study.
ā. SF \>15 Āµg/L and \<60 Āµg/L \[WHO uses the following cut-offs for context: below 15 Āµg/L indicates iron deficiency, 16-40 Āµg/L indicates borderline deficiency, and 41 - 150 Āµg/L is normal\].
ā. Body Mass Index (BMI) between 18.5 - 40 kg/m2.
ā. Live within 40 miles of the Norwich Research Park.
Exclusion criteria
ā. Those who have known allergies to the hydroponically grown salad greens (spinach, rocket, mizuna).
What they're measuring
1
Change in serum ferritin after the dietary app intervention
Timeframe: Week: 0, 6/7 and 17
2
Change of serum B12 after the hydroponic unit intervention