Iron Absorption From Naturally Dephytinized Legumes

NCT06032832 | Completed DMC

• 1 other identifier: Iron_LINDA_2023
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Iron Deficiencies

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Fractional iron absorption

  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

  Baseline, 14 days after test meal administration

Secondary Outcomes (2)

• Iron status

  Baseline, 14 days after test meal administration

• Inflammatory status

  Baseline, 14 days after test meal administration

Study Arms (3)

Soy protein concentrate meat analog

EXPERIMENTAL

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

Other: soy protein concentrate-meat analog

Soy protein concentrate meat analog without phytic acid

EXPERIMENTAL

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.

Other: soy protein concentrate-meat analog_dephytinization

minced pork meat

EXPERIMENTAL

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.

Other: pork meat

Interventions

soy protein concentrate-meat analog OTHER

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

Soy protein concentrate meat analog

soy protein concentrate-meat analog_dephytinization OTHER

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

Soy protein concentrate meat analog without phytic acid

pork meat OTHER

Meals made with minced pork meat labelled with 57Fe.

minced pork meat

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Women are vulnerable to developing iron deficiency. Thus, this study aims to study in female population according to sex.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Diego Moretti: lead

Study Sites (1)

Fernfachhochschule Schweiz (FFHS) - Campus Gleisarena

Zurich, Canton of Zurich, 8005, Switzerland

Location

MeSH Terms

Conditions

Iron Deficiencies

Interventions

Pork Meat

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Red Meat; Meat; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Diego Moretti, Ph.D

  FFHS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Test meals will be randomized and served to participants. Participants will not know or taste the differences of dephytinization in soy protein concentrate.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof.Dr. Diego Moretti

Model Details: Randomized control trial, cross-over

Study Record Dates

• First Submitted: September 4, 2023
• First Posted: September 13, 2023
• Study Start: April 8, 2025
• Primary Completion: May 20, 2025
• Study Completion: May 20, 2025
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)