Micronutrient Bioavailability From Wheat

NCT ID: NCT05536947

Last Updated: 2022-09-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-26
• Study Completion Date: 2022-12-31

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Standard-milled Wholegrain

Bread rolls prepared using standard-milled Wholegrain (75 g per bread roll, containing stable isotopes of Fe and Zn), with butter and strawberry jam.

Group Type: ACTIVE_COMPARATOR

Bread product (standard milled)

Intervention Type: OTHER

Bread rolls made from standard milled flour.

Micro-milled Wholegrain

Bread rolls prepared using Micro-milled Wholegrain (75 g per bread roll, containing stable isotopes of Fe and Zn), with butter and strawberry jam.

Group Type: EXPERIMENTAL

Bread Product (micro-milled)

Intervention Type: OTHER

Bread rolls made from micro-milled whole grain flour.

White flour fortified with standard milled Aleurone

Bread rolls prepared using a white flour and standard-milled aleurone mix (75 g per bread roll, containing stable isotope of Fe), with butter and strawberry jam.

Group Type: ACTIVE_COMPARATOR

Bread Product (standard aleurone)

Intervention Type: OTHER

Bread rolls made from white flour/standard milled aleurone mix

White flour fortified with micro-milled Aleurone

Bread rolls prepared using a white flour and micro-milled aleurone mix (75 g per bread roll, containing stable isotope of Fe), with butter and strawberry jam.

Group Type: EXPERIMENTAL

Bread product (micro-milled aleurone)

Intervention Type: OTHER

Bread rolls made from white flour/micro-milled aleurone mix.

Interventions

Bread product (standard milled)

Bread rolls made from standard milled flour.

Intervention Type: OTHER

Bread Product (micro-milled)

Bread rolls made from micro-milled whole grain flour.

Intervention Type: OTHER

Bread Product (standard aleurone)

Bread rolls made from white flour/standard milled aleurone mix

Intervention Type: OTHER

Bread product (micro-milled aleurone)

Bread rolls made from white flour/micro-milled aleurone mix.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

King's College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul A Sharp, PhD

Role: PRINCIPAL_INVESTIGATOR

King's College London, Department of Nutritional Sciences

Locations

King's College London

London, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Mohamad F Aslam, PhD

Role: CONTACT

micronutrient@kcl.ac.uk

020 7836 5454

Paul A Sharp, PhD

Role: CONTACT

micronutrient@kcl.ac.uk

020 7836 5454

Facility Contacts

Mohamad Farshard C Aslam, PhD

Role: primary

micronutrient@kcl.ac.uk

02078484331

Other Identifiers

HR-18/19-5718

Identifier Type: -

Identifier Source: org_study_id