Micronutrient Bioavailability From Wheat

Healthy Clinical Trial

Official title:

Micronutrient Bioavailability From Wheat

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05536947
• Other study ID #: HR-18/19-5718
• Status: Recruiting
• Phase: N/A
• Start date: November 26, 2021
• Est. completion date: December 2022

Study information

• Verified date: November 2021
• Source: King's College London
• Contact: Mohamad F Aslam, PhD
• Phone: 020 7836 5454
• Email: micronutrient[@]kcl.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years to 49 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Bread product (standard milled)
Bread rolls made from standard milled flour.
• Bread Product (micro-milled)
Bread rolls made from micro-milled whole grain flour.
• Bread Product (standard aleurone)
Bread rolls made from white flour/standard milled aleurone mix
• Bread product (micro-milled aleurone)
Bread rolls made from white flour/micro-milled aleurone mix.

Locations

Country	Name	City	State
United Kingdom	King's College London	London

Sponsors (1)

Lead Sponsor	Collaborator
King's College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analysis of 57-Fe incorporation into erythrocytes	Determines Fe incorporation from test meal into Red Blood Cells	Through study completion, an average of 1 year
Primary	Urinary excretion of Zinc	Determine excretion of Zinc in urine samples to assess Zinc bioavailability	Through study completion, an average of 1 year
Secondary	Analysis of iron status biomarkers from blood samples	Determine Hepcidin concentration from sample	Through study completion, an average of 1 year