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Completed

NCT Number: NCT05392816

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Chalmers University of Technology, Division of Food Science

Gothenburg, 41296, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Single meal non-heme iron absorption

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.

Primary outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

Chalmers University of Technology

Other

Collaborators

  • Göteborg University

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 26, 2022
Registry last updated
Jun 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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