Micronutrient Bioavailability From Wheat

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

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Other: Bread product (standard milled); Other: Bread Product (micro-milled); Other: Bread Product (standard aleurone); Other: Bread product (micro-milled aleurone)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamad F Aslam, PhD; Phone Number: 020 7836 5454; Email: micronutrient@kcl.ac.uk
• Study Contact Backup: Name: Paul A Sharp, PhD; Phone Number: 020 7836 5454; Email: micronutrient@kcl.ac.uk

Study Locations

• United Kingdom
  • London, United Kingdom
    • Recruiting
    • King's College London
    • Contact: Mohamad Farshard C Aslam, PhD; Phone Number: 02078484331; Email: micronutrient@kcl.ac.uk
    • Principal Investigator: Paul A Sharp, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 49 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: TRIPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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.	Other: Bread product (standard milled); Bread rolls made from standard milled flour.
EXPERIMENTAL: 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.	Other: Bread Product (micro-milled); Bread rolls made from micro-milled whole grain flour.
ACTIVE_COMPARATOR: 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.	Other: Bread Product (standard aleurone); Bread rolls made from white flour/standard milled aleurone mix
EXPERIMENTAL: 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.	Other: Bread product (micro-milled aleurone); Bread rolls made from white flour/micro-milled aleurone mix.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Urinary excretion of Zinc	Determine excretion of Zinc in urine samples to assess Zinc bioavailability	Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analysis of iron status biomarkers from blood samples	Determine Hepcidin concentration from sample	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: King's College London
• Investigators: Principal Investigator: Paul A Sharp, PhD, King's College London, Department of Nutritional Sciences

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 26, 2021
• Primary Completion (ANTICIPATED): December 1, 2022
• Study Completion (ANTICIPATED): December 1, 2022

Study Registration Dates

• First Submitted: December 14, 2021
• First Submitted That Met QC Criteria: September 7, 2022
• First Posted (ACTUAL): September 13, 2022

Study Record Updates

• Last Update Posted (ACTUAL): September 13, 2022
• Last Update Submitted That Met QC Criteria: September 7, 2022
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: HR-18/19-5718

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No