Iron DeficienciesLINDANCT06032832
Iron Absorption From Naturally Dephytinized Legumes
A study testing soy protein concentrate-meat analog, soy protein concentrate-meat analog_dephytinization and pork meat in people with Iron Deficiencies, run by Diego Moretti at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiencies
- What is being tested?
- soy protein concentrate-meat analog, soy protein concentrate-meat analog_dephytinization and pork meat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteSwitzerland
- Study dates
- 8 Apr 2025to 20 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female aged between 18-45 y old
- Plasma ferritin < 30 microgram/L
- BMI 18.5-25.0
- Weight < 65 kg
- Signed informed consent
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Fernfachhochschule Schweiz (FFHS) - Campus Gleisarena
Zurich, Canton of Zurich, 8005
About this study
Official 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
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.
Read more
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.
Read the 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
- Being tested
- soy protein concentrate-meat analog, soy protein concentrate-meat analog_dephytinization, pork meat
- Keywords
- plant based meat alternative, iron absorption, soy protein, phytic acid, dephytinization
- Medical subject headings
- Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
soy protein concentrate-meat analogOther
Baked Meat analogs-soy protein concentrate containing 57Fe as ferrous sulfate
soy protein concentrate-meat analog_dephytinizationOther
Baked dephytinized_Meat analogs-soy protein concentrate containing 58Fe as ferrous sulfate
pork meatOther
Meals made with minced pork meat labelled with 57Fe.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: pork meat |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 14 days after test meal administration
Secondary outcomes (2)
Iron status
Hemoglobin (Hb), plasma ferritin (PF), and serum soluble transferrin receptor (sTfR)
Measured: Baseline, 14 days after test meal administration
Inflammatory status
Alpha-1-acid glycoprotein (AGP), C-reactive protein (CRP)
Measured: Baseline, 14 days after test meal administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start8 Apr 2025
- Primary completion20 May 2025
- Study completion20 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron DeficienciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized control trial, cross-over
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diego Moretti
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Diego Moretti, Swiss Distance University of Applied Sciences
- Investigators
- Diego Moretti, Ph.D, Principal investigator, FFHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06032832
- Sponsor's protocol ID
- Iron_LINDA_2023
- Acronym
- LINDA
- Status last verified
- Jun 2025
- First submitted
- 4 Sep 2023
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06032832
- Acronym / sponsor ID
- LINDA / Iron_LINDA_2023
- Conditions
- Iron Deficiencies
- Keywords
- plant based meat alternative, iron absorption, soy protein, phytic acid, dephytinization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Diego MorettiUniversity, hospital or other
- Study start
- 8 Apr 2025 (actual)
- Primary completion
- 20 May 2025 (actual)
- Study completion
- 20 May 2025 (actual)
- First posted
- 13 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Randomized control trial, cross-over
| Arm | Type | Receives |
|---|---|---|
| Soy protein concentrate meat analog | Experimental | Other: soy protein concentrate-meat analogMeat analog made from soy protein concentrate contains 57Fe as ferrous sulfate. All participants will consume this test meal. |
| Soy protein concentrate meat analog without phytic acid | Experimental | Other: soy protein concentrate-meat analog_dephytinizationMeat analog made from soy protein concentrate that was removed phytic acid (dephytinization) contains 58Fe as ferrous sulfate. All participants will consume this test meal. |
| minced pork meat | Experimental | Other: pork meatA meal based on minced pork meat, containing 57Fe intrinsically, will be prepared and served to the participants. All participants will consume this test meal. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Female aged between 18-45 y old
- Plasma ferritin < 30 microgram/L
- BMI 18.5-25.0
- Weight < 65 kg
- Signed informed consent
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| soy protein concentrate-meat analogBaked Meat analogs-soy protein concentrate containing 57Fe as ferrous sulfate | Other | Soy protein concentrate meat analog |
| soy protein concentrate-meat analog_dephytinizationBaked dephytinized_Meat analogs-soy protein concentrate containing 58Fe as ferrous sulfate | Other | Soy protein concentrate meat analog without phytic acid |
| pork meatMeals made with minced pork meat labelled with 57Fe. | Other | minced pork meat |
Primary outcome
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
2 secondary outcomes
Iron status
Time frame: Baseline, 14 days after test meal administration
Inflammatory status
Time frame: Baseline, 14 days after test meal administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diego Moretti, Ph.D principal investigator
FFHS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing soy protein concentrate-meat analog, soy protein concentrate-meat analog_dephytinization and pork meat in people with Iron Deficiencies, run by Diego Moretti at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fractional iron absorption (time frame: Baseline, 14 days after test meal administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.