Micronutrient Bioavailability From Wheat

Sponsor
King's College London (Other)
Overall Status
Recruiting
CT.gov ID
NCT05536947
Collaborator
(none)
25
1
4
12.2
2.1

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Bread product (standard milled)
  • Other: Bread Product (micro-milled)
  • Other: Bread Product (standard aleurone)
  • Other: Bread product (micro-milled aleurone)
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
25 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Prevention
Official Title:
Micronutrient Bioavailability From Wheat
Actual Study Start Date :
Nov 26, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Analysis of 57-Fe incorporation into erythrocytes [Through study completion, an average of 1 year]

    Determines Fe incorporation from test meal into Red Blood Cells

  2. Urinary excretion of Zinc [Through study completion, an average of 1 year]

    Determine excretion of Zinc in urine samples to assess Zinc bioavailability

Secondary Outcome Measures

  1. Analysis of iron status biomarkers from blood samples [Through study completion, an average of 1 year]

    Determine Hepcidin concentration from sample

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 49 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 King's College London London United Kingdom

Sponsors and Collaborators

  • King's College London

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
King's College London
ClinicalTrials.gov Identifier:
NCT05536947
Other Study ID Numbers:
  • HR-18/19-5718
First Posted:
Sep 13, 2022
Last Update Posted:
Sep 13, 2022
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Sep 13, 2022