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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05392816
• Other study ID #: 573-18
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Healthy

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