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

• Sponsor: Chalmers University of Technology (Other)
• Overall Status: Completed
• CT.gov ID: NCT05392816
• Collaborator: Göteborg University (Other)
• Enrollment: 30
• Location: 1
• Arms: 2
• Actual Duration (Months): 8.8
• Patients Per Site Per Month: 3.4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy; Nutrition, Healthy	Other: Single meal non-heme iron absorption	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Masking Description: Meals are served from identical plastic boxes. Participants are served the meals in a separate room from preparation
• Primary Purpose: Other
• Official Title: Non-heme Iron Absorption From Single Meals of Fava Bean Protein, Beef Protein and Cod Protein in Healthy Females in Fertile Ages
• Actual Study Start Date: Sep 6, 2021
• Actual Primary Completion Date: Jun 2, 2022
• Actual Study Completion Date: Jun 2, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. 59Fe non-heme iron absorption from cod and beef protein meals [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. [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chalmers University of Technology, Division of Food Science	Gothenburg		Sweden	41296

Sponsors and Collaborators

• Chalmers University of Technology
• Göteborg University

Investigators

• Principal Investigator: Ann-Sofie Sandberg, Professor, Chalmers University of Technology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rikard Landberg, Professor, Chalmers University of Technology
• ClinicalTrials.gov Identifier: NCT05392816
• Other Study ID Numbers: 573-18
• First Posted: May 26, 2022
• Last Update Posted: Jun 3, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jun 3, 2022