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

NCT ID: NCT05392816

Last Updated: 2022-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-06

Study Completion Date

2022-06-02

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Nutrition, Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants
Meals are served from identical plastic boxes. Participants are served the meals in a separate room from preparation

Study Groups

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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

Group Type OTHER

Single meal non-heme iron absorption

Intervention Type OTHER

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.

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

Group Type OTHER

Single meal non-heme iron absorption

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Göteborg University

OTHER

Sponsor Role collaborator

Chalmers University of Technology

OTHER

Sponsor Role lead

Responsible Party

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Rikard Landberg

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ann-Sofie Sandberg, Professor

Role: PRINCIPAL_INVESTIGATOR

Chalmers University of Technology

Locations

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Chalmers University of Technology, Division of Food Science

Gothenburg, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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573-18

Identifier Type: -

Identifier Source: org_study_id

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