Clinical trial NCT05536947: Micronutrient Bioavailability From Wheat
Official title: Micronutrient Bioavailability From Wheat
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Lead sponsor: King's College London
Sponsor class: OTHER
First posted: 2022-09-13
Enrollment: 25
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Allergic to gluten or wheat
* Pregnant
* 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.

Primary outcomes:
measure: Analysis of 57-Fe incorporation into erythrocytes
timeFrame: Through study completion, an average of 1 year
measure: Urinary excretion of Zinc
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Analysis of iron status biomarkers from blood samples
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College London
Study officials:
affiliation: King's College London, Department of Nutritional Sciences
name: Paul A Sharp, PhD
role: PRINCIPAL_INVESTIGATOR
References: