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临床试验/NCT05536947
NCT05536947Unknown不适用

Micronutrient Bioavailability From Wheat

King's College London1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2021年11月26日最近更新:
适应症

试验速览

阶段
不适用
入组人数
25
试验地点
1
主要终点
Urinary excretion of Zinc

研究概览

简要总结

The purpose of this study is to determine if physical disruption of wheat aleurone cell walls (micro-milling) increases micronutrient availability.

详细描述

This research project is a short-term dietary intervention study to investigate the bio-availability of iron and zinc from wheat. Approximately 50% of iron and 30% of zinc in the United Kingdom diet is provided by cereals and cereal products (e.g. bread and breakfast cereals). The localisation of both iron and zinc metals in wheat is largely confined to the aleurone layer, a single layer of cells located between the centre (endosperm) and outer layers (testa and pericarp). The aleurone layer is removed during the production of white flour. For this reason, since 1953 it has been mandatory to add iron to flours at the mill to restore iron to levels present in wholegrain flour (The Bread and Flour Regulations, 1998).

The investigators have shown that aleurone cells are resistant to physical disruption and digestion as they pass along the gastrointestinal tract and are excreted intact in faeces. The investigators believe that disruption of wheat aleurone cell walls prior to food manufacturing would therefore increase iron and zinc availability. Using wholegrain flour and purified wheat aleurone flour the investigators have shown that micro-milling, a process which reduces particle size of flour from approximately 100μm to 10μm, ruptures the aleurone cell walls, and increases iron availability, i.e. the amount absorbed by intestinal cells, compared with flour produced using standard milling techniques (which does not break down the aleurone layer).

Based on these initial findings, the current study therefore has 2 main aims:

(i) to determine whether physical disruption of the aleurone (by micro-milling) in wholegrain flour increases iron and zinc availability from wholegrain bread.

(ii) to determine whether addition of micro-milled aleurone flour to white flour increases iron availability from white bread.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
19 Years 至 49 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Healthy pre-menopausal women
  • Serum ferritin below 30 μg/L
  • Plasma zinc below 13.8 μmol/L.

排除标准

  • Allergic to gluten or wheat
  • Post-menopausal women
  • History of alcohol or substance abuse
  • History of Cardiovascular Disease, diabetes, cancer, kidney, liver or intestinal disease, gastrointestinal disorder or use of drugs likely to alter gastrointestinal function.
  • Donated blood recently (within 3 months prior to screening visit)
  • Volunteers planning to take any mineral or vitamin supplements during the course of the study.

结局指标

主要结局

Urinary excretion of Zinc

时间窗: Through study completion, an average of 1 year

Determine excretion of Zinc in urine samples to assess Zinc bioavailability

Analysis of 57-Fe incorporation into erythrocytes

时间窗: Through study completion, an average of 1 year

Determines Fe incorporation from test meal into Red Blood Cells

次要结局

  • Analysis of iron status biomarkers from blood samples(Through study completion, an average of 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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Micronutrient Bioavailability From Wheat | 临床试验