Clinical trial NCT06972927: VertiGreens Investigating the Effects of Iron Biofortification of Microgreens on Iron Status in Women
Official title: VertiGreens Investigating the Effects of Iron Biofortification of Microgreens on Iron Status in Women
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Iron Biomarkers/Status
Keywords: vertical farming
iron biomarkers
iron status
biofortification
microgreens
Lead sponsor: University of Aberdeen
Sponsor class: OTHER
First posted: 2025-05-15
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators present a diet intervention study, to be conducted as a within-subject design, to assess the effect of the provision of iron biofortified microgreens on iron intake and status in women of reproductive age and postmenopausal women. This will be investigated by providing smoothie kits for 28 days containing these microgreens and determining the impact on iron biomarkers. The investigators will also assess habitual diet, BMI, physical activity and gastrointestinal symptoms. This study will be a proof-of-concept exploratory study to explore diet based biofortification through vertical farming systems.

Detailed description: In this study microgreens that were grown using agronomic iron biofortification will be supplied to women to add to their diet to establish the potential nutritional impact of iron biofortified microgreens on overall iron intake and iron status. Furthermore, it will assess the adherence to the provided consumption recommendations of the biofortified crops.

Eligibility criteria: Inclusion Criteria:

* Healthy females
* 15 of reproductive age (18-49)
* 15 postmenopausal (not had their period for an entire year)

Exclusion Criteria:

Medication exclusion criteria:

* Supplementing iron or vitamin B12
* Smoking or vaping
* Taking anticoagulant medication (blood thinners) except for Aspirin 75mg

Medical exclusion criteria:

* Anyone who is planning to be pregnant, is pregnant or breastfeeding
* Anyone with iron or vitamin B12 deficiency anaemia
* Anyone with history of anaemia in the past 3 months that required treatment
* Anyone who has Hb \<120 g/L (12 g/dL) at screening
* Anyone with food allergies, self-reported food sensitivity or intolerance
* Anyone with coeliac disease or gluten intolerance
* Anyone suffering from a psychiatric disorder or any type of substance abuse
* Anyone with Type 1 diabetes and Type 2 diabetes
* Anyone suffering from unregulated thyroid disease
* Anyone with gastrointestinal conditions or bariatric surgery
* Anyone with haematological conditions including Thrombocytopaenia and Sickle cell anaemia

Other exclusion criteria:

* Anyone with unsuitable veins for blood sampling
* Anyone who donated blood in the last 16 weeks
* Anyone who is unable to fluently speak, read and understand English

Primary outcomes:
measure: Haemoglobin status change from baseline
timeFrame: Measured at study day 1 and on study day 28
measure: Serum iron status change from baseline
timeFrame: Measured at study day 1 and on study day 28
measure: Ferritin status change from baseline
timeFrame: Measured at study day 1 and on study day 28
measure: CRP change from baseline
timeFrame: Measured at study day 1 and on study day 28
measure: Dietary iron intake changes compared to habitual diet
timeFrame: every study day (28 days)
Secondary outcomes:
measure: Serum Vitamin B12 status change from baseline
timeFrame: Measured on study day 1 and on study day 28
measure: Adherence to consumption of microgreens/smoothie
timeFrame: every study day (28 days)
Other outcomes:
Locations:
city: Aberdeen
country: United Kingdom
facility: Rowett Institute, University of Aberdeen
Study officials:
affiliation: University of Aberdeen, Rowett Institute of Nutrition and Health
name: Alexandra Johnstone, Prof
role: PRINCIPAL_INVESTIGATOR
References: