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

NCT05392816 | Completed

• 1 other identifier: 573-18
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy; Nutrition, Healthy

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Study group 1. Texturized fava protein meal and beef protein meal

OTHER

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

Study group 2. Texturized fava protein meal and cod protein meal

OTHER

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

Interventions

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.

Study group 1. Texturized fava protein meal and beef protein meal; Study group 2. Texturized fava protein meal and cod protein meal

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Other sex than female
• Age \<18 and \>45
• Has an ongoing infection
• Is vegetarian
• Is pregnant or lactating
• Takes iron supplements

Sponsors & Collaborators

• Chalmers University of Technology: lead
• Göteborg University: collaborator

Study Sites (1)

Chalmers University of Technology, Division of Food Science

Gothenburg, 41296, Sweden

Location

Study Officials

• Ann-Sofie Sandberg, Professor

  Chalmers University of Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Meals are served from identical plastic boxes. Participants are served the meals in a separate room from preparation
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: May 26, 2022
• Study Start: September 6, 2021
• Primary Completion: June 2, 2022
• Study Completion: June 2, 2022
• Last Updated: June 3, 2022

Record last verified: 2022-06

Locations

SE (1)