NCT05536947

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Nov 2021

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 26, 2021

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

December 14, 2021

Completed
9 months until next milestone

First Posted

Study publicly available on registry

September 13, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

September 13, 2022

Status Verified

November 1, 2021

Enrollment Period

1 year

First QC Date

December 14, 2021

Last Update Submit

September 7, 2022

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Analysis of iron status biomarkers from blood samples

    Through study completion, an average of 1 year

Study Arms (4)

Standard-milled Wholegrain

ACTIVE COMPARATOR

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)

Micro-milled Wholegrain

EXPERIMENTAL

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)

White flour fortified with standard milled Aleurone

ACTIVE COMPARATOR

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)

White flour fortified with micro-milled Aleurone

EXPERIMENTAL

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)

Interventions

Bread product (standard milled)OTHER

Bread rolls made from standard milled flour.

Standard-milled Wholegrain
Bread Product (micro-milled)OTHER

Bread rolls made from micro-milled whole grain flour.

Micro-milled Wholegrain
Bread Product (standard aleurone)OTHER

Bread rolls made from white flour/standard milled aleurone mix

White flour fortified with standard milled Aleurone
Bread product (micro-milled aleurone)OTHER

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

White flour fortified with micro-milled Aleurone

Eligibility Criteria

Age19 Years - 49 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King's College London

London, United Kingdom

RECRUITING

Study Officials

  • Paul A Sharp, PhD

    King's College London, Department of Nutritional Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamad F Aslam, PhD

CONTACT

020 7836 5454micronutrient@kcl.ac.uk

Paul A Sharp, PhD

CONTACT

020 7836 5454micronutrient@kcl.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2021

First Posted

September 13, 2022

Study Start

November 26, 2021

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

September 13, 2022

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)