Informazioni generali
  • Categoria della malattia Altro (BASEC)
  • Fase dello studio N/A (ICTRP)
  • Stato di reclutamento reclutamento non ancora iniziato (BASEC/ICTRP)
  • Luogo dello studio
    Zurigo
    (BASEC)
  • Responsabile dello studio Prof. Dr. Diego Moretti diego.moretti@ffhs.ch (BASEC)
  • Fonte dati BASEC: Importato da 11.03.2025 ICTRP: Importato da 28.06.2025
  • Ultimo aggiornamento 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

  • Categoria della malattia Altro (BASEC)
  • Fase dello studio N/A (ICTRP)
  • Stato di reclutamento reclutamento non ancora iniziato (BASEC/ICTRP)
  • Luogo dello studio
    Zurigo
    (BASEC)
  • Responsabile dello studio Prof. Dr. Diego Moretti diego.moretti@ffhs.ch (BASEC)
  • Fonte dati BASEC: Importato da 11.03.2025 ICTRP: Importato da 28.06.2025
  • Ultimo aggiornamento 28.06.2025 02:00

Descrizione riassuntiva dello studio

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)

Intervento studiato

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)

Malattie studiate

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)

Criteri di partecipazione
- Women aged 18-45 years - Plasma ferritin < 30 mg/L - Weight < 65 kg (BASEC)

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

Luogo dello studio

Zurigo

(BASEC)

Switzerland (ICTRP)

Sponsor

Swiss National Science Foundation (SNSF)

(BASEC)

Contatto per ulteriori informazioni sullo studio

Persona di contatto in Svizzera

Prof. Dr. Diego Moretti

+41 44 512 09 20

diego.moretti@ffhs.ch

Fernfachhochschule Schweiz (FFHS), SUPSI

(BASEC)

Informazioni generali

FFHS,

+41 44 512 09 75;+41445120920

diego.moretti@ffhs.ch

(ICTRP)

Informazioni generali

FFHS

+41 44 512 10 01+41445120920

diego.moretti@ffhs.ch

(ICTRP)

Informazioni generali

FFHS

(ICTRP)

Informazioni scientifiche

FFHS,

+41 44 512 09 75;+41445120920

diego.moretti@ffhs.ch

(ICTRP)

Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)

Commissione etica Zurigo

(BASEC)

Data di approvazione del comitato etico

04.02.2025

(BASEC)


ID di studio ICTRP
NCT06032832 (ICTRP)

Titolo ufficiale (approvato dal comitato etico)
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)

Titolo accademico
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)

Titolo pubblico
Iron Absorption From Naturally Dephytinized Legumes (ICTRP)

Malattie studiate
Iron Deficiencies (ICTRP)

Intervento studiato
Other: soy protein concentrate-meat analogOther: soy protein concentrate-meat analog_dephytinizationOther: pork meat (ICTRP)

Tipo di studio
Interventional (ICTRP)

Disegno dello studio
Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Prevention. Masking: Single (Participant). (ICTRP)

Criteri di inclusione/esclusione
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)

non disponibile

Endpoint primari e secondari
Fractional iron absorption (ICTRP)

Iron status;Inflammatory status (ICTRP)

Data di registrazione
non disponibile

Inclusione del primo partecipante
non disponibile

Sponsor secondari
non disponibile

Contatti aggiuntivi
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)

ID secondari
Iron_LINDA_2023 (ICTRP)

Risultati-Dati individuali dei partecipanti
non disponibile

Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT06032832 (ICTRP)

Risultati dello studio

Riepilogo dei risultati

non disponibile

Link ai risultati nel registro primario

non disponibile