Iron Absorption From Naturally Dephytinized Legumes

NCT ID: NCT06032832

Last Updated: 2025-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-08
• Study Completion Date: 2025-05-20

Brief Summary

Consumption of less meat and more plant-based protein can greatly reduce the negative impact of food production on the environment. Studies show that vegan diets can decrease greenhouse gas emissions, land use, and water. However, it is important to consider the nutritional value of alternatives, as meat is a key source of nutrients like iron. Iron deficiency anemia (IDA) is estimated to be the top 5 leading causes of years lived with disability burden globally and the first cause in women. Nutritional iron deficiency anemia is often caused by low iron content and low dietary iron bioavailability. As meat, fish, and poultry are excellent sources of bioavailable iron, shifting or maintaining a predominantly plant-based diet can increase the risk of iron deficiency (ID).

Phytic acid, the main phosphorus storage compound in plants, can hinder iron absorption and other divalent minerals. Phytase is an enzyme that breaks down phytic acid, which lessens its ability to bind with minerals like iron. This enzyme is present in various plant tissues, with particularly high amounts found in wheat and rye.

There is limited clinical evidence regarding iron absorption from plant-based meat. Thus, it is important to measure iron absorption from plant-based foods before and after treatment to remove phytic acid (dephytinization).

The aim of this study is to determine the effect of phytic acid reduction on iron absorption. FIA of the soy protein concentrates meat analog with phytic acid will be compared with FIA from soy protein concentrate with dephytinization. In addition, this study will assess the FIA in a pork meat meal and will compare it to the FIA from the dephytinized meat analog.

Detailed Description

The goal of this clinical trial is to assess the iron absorption from plant-based protein with and without the reduction of phytic acid. This study is a randomized control trial, cross-over where each participant acts as their own control.

Participants will be asked to consume test meals prepared from soy with and without dephytinization and test meals based on minced pork meat, that contains isotopic iron (57Fe and 58Fe) as ferrous sulfate. After 14 days of the test meal administration, participants will be given blood samples to access the isotopic iron enrichment in blood.

Conditions

Iron Deficiencies

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Soy protein concentrate meat analog

Meat analog made from soy protein concentrate contains 57Fe as ferrous sulfate. All participants will consume this test meal.

Group Type: EXPERIMENTAL

soy protein concentrate-meat analog

Intervention Type: OTHER

Baked Meat analogs-soy protein concentrate containing 57Fe as ferrous sulfate

Soy protein concentrate meat analog without phytic acid

Meat analog made from soy protein concentrate that was removed phytic acid (dephytinization) contains 58Fe as ferrous sulfate. All participants will consume this test meal.

Group Type: EXPERIMENTAL

soy protein concentrate-meat analog_dephytinization

Intervention Type: OTHER

Baked dephytinized\_Meat analogs-soy protein concentrate containing 58Fe as ferrous sulfate

minced pork meat

A meal based on minced pork meat, containing 57Fe intrinsically, will be prepared and served to the participants. All participants will consume this test meal.

Group Type: EXPERIMENTAL

pork meat

Intervention Type: OTHER

Meals made with minced pork meat labelled with 57Fe.

Interventions

soy protein concentrate-meat analog

Baked Meat analogs-soy protein concentrate containing 57Fe as ferrous sulfate

Intervention Type: OTHER

soy protein concentrate-meat analog_dephytinization

Baked dephytinized\_Meat analogs-soy protein concentrate containing 58Fe as ferrous sulfate

Intervention Type: OTHER

pork meat

Meals made with minced pork meat labelled with 57Fe.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Female aged between 18-45 y old
• Plasma ferritin < 30 microgram/L
• BMI 18.5-25.0
• Weight < 65 kg
• Signed informed consent

Exclusion Criteria

• Anemic (Hb < 12 g/dL)
• Inflammation (CRP > 5 mg/L)
• Chronic digestive, renal and/or metabolic disease
• Chronic medications (except for oral contraceptives)
• Use of vitamin, mineral, and pre-and/or probiotic supplements in the previous 2 weeks and during the study
• Blood transfusion, blood donation, or significant blood loss (> 400 ml) over the past 4 months
• Difficulty with blood withdrawal
• Antibiotic treatment in the 4 weeks preceding the start of the study and during the study
• Pregnancy (tested in serum at screening) or intention to become pregnant during the course of the study
• Lactation
• Earlier participation in a study using stable isotopes or participation in any clinical study within the last 30 days
• Participants who cannot be expected to comply with the study protocol (e.g. not available on certain study appointments)
• Inability to understand the information sheet and the informed consent form due to cognitive or language reasons
• Smoking
• celiac disease or gluten intolerance
• Vegetarian or vegan dietary regimen

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Diego Moretti

OTHER

Sponsor Role: lead

Responsible Party

Diego Moretti

Prof.Dr. Diego Moretti

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Diego Moretti, Ph.D

Role: PRINCIPAL_INVESTIGATOR

FFHS

Locations

Fernfachhochschule Schweiz (FFHS) - Campus Gleisarena

Zurich, Canton of Zurich, Switzerland

Countries

Switzerland

Other Identifiers

Iron_LINDA_2023

Identifier Type: -

Identifier Source: org_study_id