VertiGreens Investigating the Effects of Iron Biofortification of Microgreens on Iron Status in Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Haemoglobin status change from baseline
研究概览
简要总结
The investigators present a pilot diet intervention study, to be conducted as a within-subject design, to assess the feasibility 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy females
- •15 of reproductive age (18-49)
- •15 postmenopausal (not had their period for an entire year)
排除标准
- •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 to banana, mango, pineapple, coconut
- •Anyone with coeliac disease
- •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
研究组 & 干预措施
Vertigreens
Phase 1: Habitual diet (1 week) Phase 2: Vertigreens diet: One smoothie a day containing biofortified microgreens (4 weeks)
干预措施: Smoothie containing iron biofortified microgreens (Other)
结局指标
主要结局
Haemoglobin status change from baseline
时间窗: Measured at study day 1 and on study day 28
Iron status changes in haemoglobin
Serum iron status change from baseline
时间窗: Measured at study day 1 and on study day 28
Iron status changes in serum iron
Ferritin status change from baseline
时间窗: Measured at study day 1 and on study day 28
Iron status changes in ferritin
CRP change from baseline
时间窗: Measured at study day 1 and on study day 28
Changes in CRP
Dietary iron intake changes compared to habitual diet
时间窗: every study day (28 days)
Dietary iron intake changes in iron intake compared to habitual diet measured though food diaries
次要结局
- Serum Vitamin B12 status change from baseline(Measured on study day 1 and on study day 28)
- Adherence to consumption of microgreens/smoothie(every study day (28 days))