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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Olla
Al-Jaibaji
Olla.Al-Jaibaji@quadram.ac.uk
Dr
Paul
Kroon
paul.kroon@quadram.ac.uk
Nutritional anaemias
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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.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Interventional type: Gene Therapy;
You can take part if:
You may not be able to take part if:
a) Those who have known allergies to the hydroponically grown salad greens (parsley, rocket, mizuna). b) Flexitarian (consumes meat intermittently) vegetarian. c) Those with menstruation cycle time periods of < 21 or > 40-days d) BMI at screening visit < 18.5 kg/m2 (underweight) and > 40 kg/m2 (severely obese). e) Those diagnosed with or undergoing treatment for anaemia. f) Currently pregnant, lactating or trying to conceive. g) High alcohol consumption, consuming more than 2 drinks per day, can elevate the risk for iron overload. h) Current smoker or has only ceased in the last 6 months. i) Take regular dietary supplements that contain a form of Fe or vitamin B12. j) Diagnosed medical conditions that may impact the study outcomes will be considered on an individual basis. k) On, 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). l) Unable to give written or verbal informed consent. m) Individuals who cannot understand the written instructions/questionnaires. n) Unwilling to give GP contact details. o) Participating in another dietary intervention study or has given blood in another research study during the last 3 months. p) Any person related to or living with any member of the study team. q) Those who are part of the Line Manager/supervisory structure of the Chief Investigator. r) 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.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by QUADRAM INSTITUTE BIOSCIENCE and funded by Biotechnology & Biological Sciences Research Council .
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Read full details
for Trial ID: CPMS 53866
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