Non-heme Iron Absorption From Single Meals of Fava Bean Protein, Beef Protein and Cod Protein

June 2, 2022 updated by: Rikard Landberg, Chalmers University of Technology

Non-heme Iron Absorption From Single Meals of Fava Bean Protein, Beef Protein and Cod Protein in Healthy Females in Fertile Ages

The aim of this study is to investigate the non-heme iron absorption from single meals of texturized fava bean protein, which has been suggested as a protein source suitable for replacement of meat, compared to the non-heme iron absorption from beef protein and cod protein meals. The study participants are women of fertile ages, which is one of the main groups at risk of developing iron deficiency. Since a dietary shift towards increasingly plant based is being pushed, investigating nutritional effects of such a shift is essential to avoid potential negative effects such as an increase of nutritional deficiencies. The study includes two cross-over single-blinded iron isotope trials in apparent healthy Swedish women of the ages 18-45 years, each of whom served as their own control. Participants will be served matched test meals containing beef and fava bean protein (Study 1), or cod and fava bean protein (Study 2) with radiolabeled non-heme iron 55Fe and 59Fe. Absorption of non-heme iron from test meals will be measured by whole-body counting, and erythrocyte incorporation by liquid scintillation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Gothenburg, Sweden, 41296
        • Chalmers University of Technology, Division of Food Science

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female
  • Age 18-45
  • Is tolerant to intake of fava bean
  • Eats fish and meat
  • Feels healthy
  • Can eat a breakfast consisting of three potato-based patties

Exclusion Criteria:

  • Other sex than female
  • Age <18 and >45
  • Has an ongoing infection
  • Is vegetarian
  • Is pregnant or lactating
  • Takes iron supplements

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Study group 1. Texturized fava protein meal and beef protein meal
Participants recruited to study group 1 will be served a meal with fava bean protein (B) and beef protein (A), each meal twice which in total brings four meals on four consecutive days as fasting breakfast. Meals are served in the order BBAA
Other: Single meal non-heme iron absorption
Two study groups, each designed as cross-over single-blinded iron isotope trials in apparent healthy Swedish women of the ages 18-45 years. Each participant serves as their own control. Meals are tagged with radiolabeled non-heme iron 55Fe and 59Fe.
Other: Study group 2. Texturized fava protein meal and cod protein meal
Participants recruited to study group 1 will be served a meal with fava bean protein (B) and cod protein (A), each meal twice which in total brings four meals on four consecutive days as fasting breakfast. Meals are served in the order BBAA
Other: Single meal non-heme iron absorption
Two study groups, each designed as cross-over single-blinded iron isotope trials in apparent healthy Swedish women of the ages 18-45 years. Each participant serves as their own control. Meals are tagged with radiolabeled non-heme iron 55Fe and 59Fe.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
59Fe non-heme iron absorption from cod and beef protein meals
Time Frame: 5 weeks
Absorption of 59Fe, which is added to the animal protein meals, will be measured by a whole body counter which enables measurement of absolute value.
5 weeks
55Fe non-heme iron absorption from fava bean protein meals.
Time Frame: 5 weeks
The absorption quota of 59Fe/55Fe is measured by erythrocyte incorporation, analyzed by liquid scintillation. The absorbance quota, in combination with the absolute value of the whole body counter, will be used to calculate the absorbance of 55Fe which is added to the fava bean meals
5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chalmers University of Technology

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Göteborg University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ann-Sofie Sandberg, Professor, Chalmers University of Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 6, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 2, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 2, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 17, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 26, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 3, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 573-18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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