General information
  • Disease category Other (BASEC)
  • Study Phase N/A (ICTRP)
  • Recruitment status recruitment not started yet (BASEC/ICTRP)
  • Trial sites
    Zurich
    (BASEC)
  • Contact Prof. Dr. Diego Moretti diego.moretti@ffhs.ch (BASEC)
  • Data Source(s) BASEC: Import from 11.03.2025 ICTRP: Import from 28.06.2025
  • Last update 28.06.2025 02:00
HumRes63247 | SNCTP000006263 | BASEC2023-01663 | NCT06032832

The impact of dephytinization on iron absorption from a meat analog based on soy protein and chickpea farinata: a randomized study in young women

  • Disease category Other (BASEC)
  • Study Phase N/A (ICTRP)
  • Recruitment status recruitment not started yet (BASEC/ICTRP)
  • Trial sites
    Zurich
    (BASEC)
  • Contact Prof. Dr. Diego Moretti diego.moretti@ffhs.ch (BASEC)
  • Data Source(s) BASEC: Import from 11.03.2025 ICTRP: Import from 28.06.2025
  • Last update 28.06.2025 02:00

Summary description of the study

The aim of this study is to investigate the effect of dephytinization (breakdown of phytic acid) on iron absorption in young women with non-anemic iron deficiency. We hypothesize that iron absorption from plant-based meals prepared with dephytinized soy protein concentrate (SPC) or chickpea flour will be higher compared to the corresponding meals without dephytinization. The experimental phase will last 45 days. During the study, each participant will consume assigned meals. These will be randomly distributed and taken on days 1–2, 8–9, 23–24, and 30–31 both in the morning and at noon. A total of 16 meals are planned. The test meal consists of a soy-based meat analog product with or without dephytinization or farinata with or without dephytinization, served with a vegetable sauce and 150 ml of water. Participants will only be informed of the exact composition and order of the test meals at the end of the study. Each meal contains approximately 4.2 mg of iron. Of this, 20% of the total iron will be in the form of isotopic markers (either ⁵⁷Fe or ⁵⁸Fe) as FeSO₄. On days 1, 23, and 45, a blood sample will be taken to perform iron isotope analyses as well as measurements of iron status and inflammatory markers. The study will be conducted at the Laboratory of Nutrition and Metabolic Epigenetics at ETH Zurich.

(BASEC)

Intervention under investigation

Specifically, we plan to measure iron availability from 4 standardized test treatments enriched with equivalent amounts of iron(II) sulfate (FeSO4), as described below:

 

1. Meat substitute prepared with dephytinized soy protein concentrate.

 

2. Meat substitute prepared with soy protein concentrate.

 

3. Farinata prepared with dephytinized chickpea flour.

 

4. Farinata prepared with chickpea flour.

(BASEC)

Disease under investigation

A shift to more plant-based, protein-rich foods as meat substitutes requires an assessment of their nutritional value, as meat provides important nutrients such as iron. Iron from animal foods (heme iron) is particularly well absorbed by the body (15–40%), while iron from plant foods (non-heme iron) is less efficiently utilized. Additionally, there are substances like phytic acid that block iron absorption in the gut. Phytic acid is a natural substance found in many plant foods such as legumes, grains, and nuts. It binds minerals like iron, zinc, and calcium, making them inaccessible for absorption in the gut. Therefore, a reduction in phytic acid may promote human iron absorption. Iron deficiency anemia (IDA) is one of the leading causes of lost healthy years of life worldwide, particularly among women. This is often due to a diet low in iron or the difficulty of the body to utilize the iron in food. A plant-based diet can increase the risk of iron deficiency if no measures are taken to enhance iron bioavailability. Studies show that plant-based meat alternatives often contain little iron and a lot of phytic acid. To improve iron absorption, the ratio of phytic acid to iron should be as low as possible (below 1, preferably below 0.4). There are methods to reduce the phytic acid content, such as grinding, using enzymes (phytase), or adding grains that contain natural phytase. Phytase breaks down phytic acid and makes iron more available. This study investigates how well the body can absorb iron from soy meat substitutes and chickpea pancakes (farinata) – each with and without phytic acid breakdown. The aim is to measure the effect of this treatment on iron absorption and to assess whether such foods can serve as favorable and effective plant-based alternatives to meat.

(BASEC)

Criteria for participation in trial
- Women aged 18-45 years - Plasma ferritin < 30 mg/L - Weight < 65 kg (BASEC)

Exclusion criteria
- Anemia (Hb < 12 g/dL) - Inflammation (CRP > 5 mg/L) - Chronic digestive, kidney, and/or metabolic diseases (BASEC)

Trial sites

Zurich

(BASEC)

Switzerland (ICTRP)

Sponsor

Swiss National Science Foundation (SNSF)

(BASEC)

Contact

Contact Person Switzerland

Prof. Dr. Diego Moretti

+41 44 512 09 20

diego.moretti@ffhs.ch

Fernfachhochschule Schweiz (FFHS), SUPSI

(BASEC)

General Information

FFHS,

+41 44 512 09 75;+41445120920

diego.moretti@ffhs.ch

(ICTRP)

General Information

FFHS

+41 44 512 10 01+41445120920

diego.moretti@ffhs.ch

(ICTRP)

General Information

FFHS

(ICTRP)

Scientific Information

FFHS,

+41 44 512 09 75;+41445120920

diego.moretti@ffhs.ch

(ICTRP)

Name of the authorising ethics committee (for multicentre studies, only the lead committee)

Ethics Committee Zurich

(BASEC)

Date of authorisation

04.02.2025

(BASEC)


ICTRP Trial ID
NCT06032832 (ICTRP)

Official title (approved by ethics committee)
Der Effekt der Dephytinisierung auf die Eisenaufnahme aus einem Soja-Protein-basierten Fleischanalogon im Vergleich zu Schweinefleisch: eine randomisierte Studie an jungen Frauen (Kurztitel: LINDA) (BASEC)

Academic 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 (ICTRP)

Public title
Iron Absorption From Naturally Dephytinized Legumes (ICTRP)

Disease under investigation
Iron Deficiencies (ICTRP)

Intervention under investigation
Other: soy protein concentrate-meat analogOther: soy protein concentrate-meat analog_dephytinizationOther: pork meat (ICTRP)

Type of trial
Interventional (ICTRP)

Trial design
Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Prevention. Masking: Single (Participant). (ICTRP)

Inclusion/Exclusion 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

- celiac disease or gluten intolerance

- Vegetarian or vegan dietary regimen (ICTRP)

not available

Primary and secondary end points
Fractional iron absorption (ICTRP)

Iron status;Inflammatory status (ICTRP)

Registration date
not available

Incorporation of the first participant
not available

Secondary sponsors
not available

Additional contacts
Diego Moretti, Ph.D;Pornpimol Scheuchzer, Ph.D;Diego Moretti, Ph.D, pornpimol.scheuchzer@ffhs.ch; diego.moretti@ffhs.ch, +41 44 512 09 75;+41445120920, FFHS, (ICTRP)

Secondary trial IDs
Iron_LINDA_2023 (ICTRP)

Results-Individual Participant Data (IPD)
not available

Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT06032832 (ICTRP)

Results of the trial

Results summary

not available

Link to the results in the primary register

not available