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NCT Number: NCT06032832

Iron Absorption From Naturally Dephytinized Legumes

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.

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Key information

Conditions

Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fernfachhochschule Schweiz (FFHS) - Campus Gleisarena

Zurich, Canton of Zurich, 8005, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

soy protein concentrate-meat analog

Other

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

soy protein concentrate-meat analog_dephytinization

Other

Baked dephytinized_Meat analogs-soy protein concentrate containing 58Fe as ferrous sulfate

pork meat

Other

Meals made with minced pork meat labelled with 57Fe.

Primary outcomes

  1. Fractional iron absorption

    Time frame: Baseline, 14 days after test meal administration

    The fraction of absorbed iron from isotopic iron contained in the test meal. This fractional iron absorption will be measured from blood sample after 14 days from test meal administration

Secondary outcomes

  1. Iron status

    Time frame: Baseline, 14 days after test meal administration

    Hemoglobin (Hb), plasma ferritin (PF), and serum soluble transferrin receptor (sTfR)

  2. Inflammatory status

    Time frame: Baseline, 14 days after test meal administration

    Alpha-1-acid glycoprotein (AGP), C-reactive protein (CRP)

Sponsors and collaborators

Lead sponsor

Diego Moretti

Other

Registry information

Official study title

The Effect of Dephytinization on Iron Absorption From a Soy Protein Based Meat Analog, Compared to a Reference Pork Meat Meal: a Randomized Study in Young Women

Acronym: LINDA

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 13, 2023
Registry last updated
Jun 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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