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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05392816
Other study ID # 573-18
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 6, 2021
Est. completion date June 2, 2022

Study information

Verified date June 2022
Source Chalmers University of Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date June 2, 2022
Est. primary completion date June 2, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Sweden Chalmers University of Technology, Division of Food Science Gothenburg

Sponsors (2)

Lead Sponsor Collaborator
Chalmers University of Technology Göteborg University

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary 59Fe non-heme iron absorption from cod and beef protein meals 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
Primary 55Fe non-heme iron absorption from fava bean protein meals. 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
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