Assessing iron absorption from plant-based proteins
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
This study tests if reducing phytic acid in soy protein meals helps people absorb more iron from plant-based foods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 22 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Swiss Distance University of Applied Sciences Academic / other |
| Locations | 1 site (Zürich) |
| Trial ID | NCT06032832 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates how well iron is absorbed from plant-based proteins, specifically soy, when phytic acid is reduced. It employs a randomized control, cross-over design where participants consume meals made from soy protein with and without dephytinization, as well as minced pork meat containing isotopic iron. After a 14-day period of consuming these test meals, blood samples will be taken to measure isotopic iron enrichment. The study aims to provide insights into improving iron bioavailability in plant-based diets.
Who should consider this trial
Good fit: Ideal candidates are healthy females aged 18-45 with low plasma ferritin levels and a BMI between 18.5 and 25.
Not a fit: Patients who are anemic, pregnant, or have chronic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance dietary strategies for preventing iron deficiency anemia, particularly in individuals following plant-based diets.
How similar studies have performed: While studies on iron absorption from plant-based sources exist, this specific approach of dephytinization in a controlled setting is relatively novel.
Eligibility criteria
Show full 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
Where this trial is running
Zürich
- Fernfachhochschule Schweiz (FFHS) - Campus Gleisarena — Zürich, Switzerland (Recruiting)
Study contacts
- Principal investigator: Diego Moretti, Ph.D — Ffhs
- Study coordinator: Nora Barloggio, MSc
- Email: nora.barloggio@ffhs.ch
- Phone: +41 44 512 10 01
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.