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Iron Absorption From Naturally Dephytinized Legumes (LINDA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06032832
Recruitment Status : Not yet recruiting
First Posted : September 13, 2023
Last Update Posted : April 17, 2024
Sponsor:
Information provided by (Responsible Party):
Diego Moretti, Swiss Distance University of Applied Sciences

Study Description
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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). This study compares the fractional iron absorption (FIA) of the 1) soy protein concentrate meat analog and 2) Farinata made from chickpea flour, both with and without 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 without dephytinization. In addition, this study will compare the FIA in Farinata, a traditional Italian dish prepared using chickpea flour, both with and without dephytinization.


Condition or disease Intervention/treatment Phase
Iron Deficiencies Other: soy protein concentrate-meat analog Other: soy protein concentrate-meat analog_dephytinization Other: Farinata Other: Farinata_dephytinization Not Applicable

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 protein and chickpea flour with and without dephytinization 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized control trial, cross-over
Masking: Single (Participant)
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 or in chickpea.
Primary Purpose: Prevention
Official Title: The Effect of Dephytinization on Iron Absorption From a Soy Protein Based Meat Analog and Chickpea-farinata: a Randomized Study in Young Women
Estimated Study Start Date : October 2024
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

Arms and Interventions
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Arm Intervention/treatment
Experimental: Soy protein concentrate meat analog
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
Baked Meat analogs-soy protein concentrate containing 57Fe as ferrous sulfate
Experimental: 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.
 Other: soy protein concentrate-meat analog_dephytinization
Baked dephytinized_Meat analogs-soy protein concentrate containing 58Fe as ferrous sulfate
Experimental: Farinata_chickpea flour
Farinata (thin pancake) made from chickpea flour contains 57Fe as ferrous sulfate. All participants will consume this test meal.
 Other: Farinata
Pancake made from chickpea flour contains 57Fe as ferrous sulfate
Experimental: Farinata_chickpea flour without phytic acid
Farinata (thin pancake) made from chickpea flour that was removed phytic acid (dephytinization) contains 58Fe as ferrous sulfate. All participants will consume this test meal.
 Other: Farinata_dephytinization
Pancake made from dephytinized chickpea flour contains 58Fe as ferrous sulfate.


Outcome Measures
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Primary Outcome Measures :
  1. Fractional iron absorption [ Time Frame: Baseline, 14 day after test meal administration ]
    The fraction of absorbed iron from isotropic iron contain in the testmeal. This fractional iron absorption will be measure from blood sample after 14 day of test meal administration


Secondary Outcome Measures :
  1. Iron status [ Time Frame: Baseline, 14 day after test meal administration ]
    Hemoglobin (Hb), plasma ferritin (PF), and serum soluble transferrin receptor (sTfR)

  2. Inflammatory status [ Time Frame: Baseline, 14 day after test meal administration ]
    Alpha-1-acid glycoprotein (AGP), C-reactive protein (CRP)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women are vulnerable to developing iron deficiency. Thus, this study aims to study in female population according to sex.
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06032832


Contacts
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Contact: Pornpimol Scheuchzer, Ph.D +41 44 512 09 75 pornpimol.scheuchzer@ffhs.ch
Contact: Diego Moretti, Ph.D +41445120920 diego.moretti@ffhs.ch

Locations
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Switzerland
Fernfachhochschule Schweiz (FFHS) - Campus Gleisarena
Zürich, Switzerland, 8005
Contact: Diego Moretti, Ph.D    +41445120920    diego.moretti@ffhs.ch   
Sponsors and Collaborators
Diego Moretti
Investigators
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Principal Investigator: Diego Moretti, Ph.D FFHS
More Information
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Responsible Party: Diego Moretti, Prof.Dr. Diego Moretti, Swiss Distance University of Applied Sciences
ClinicalTrials.gov Identifier: NCT06032832    
Other Study ID Numbers: Iron_LINDA_2023
First Posted: September 13, 2023    Key Record Dates
Last Update Posted: April 17, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Diego Moretti, Swiss Distance University of Applied Sciences:
plant based meat alternative
iron absorption
soy protein
phytic acid
dephytinization
Additional relevant MeSH terms:
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Iron Deficiencies
Iron Metabolism Disorders
Metabolic Diseases