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Iron Absorption From Naturally Dephytinized Legumes

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06032832
Acronym
LINDA
Enrollment
19
Registered
2023-09-13
Start date
2025-04-08
Completion date
2025-05-20
Last updated
2025-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron Deficiencies

Keywords

plant based meat alternative, iron absorption, soy protein, phytic acid, dephytinization

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.

Interventions

OTHERsoy protein concentrate-meat analog

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

OTHERsoy protein concentrate-meat analog_dephytinization

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

OTHERpork meat

Meals made with minced pork meat labelled with 57Fe.

Sponsors

Diego Moretti
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Masking description

Test meals will be randomized and served to participants. Participants will not know or taste the differences of dephytinization in soy protein concentrate.

Intervention model description

Randomized control trial, cross-over

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Fractional iron absorptionBaseline, 14 days after test meal administrationThe 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

MeasureTime frameDescription
Iron statusBaseline, 14 days after test meal administrationHemoglobin (Hb), plasma ferritin (PF), and serum soluble transferrin receptor (sTfR)
Inflammatory statusBaseline, 14 days after test meal administrationAlpha-1-acid glycoprotein (AGP), C-reactive protein (CRP)

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026