Clinical trial NCT06032832: Iron Absorption From Naturally Dephytinized Legumes
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron Deficiencies
Keywords: plant based meat alternative
iron absorption
soy protein
phytic acid
dephytinization
Lead sponsor: Swiss Distance University of Applied Sciences
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 19
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized control trial, cross-over
Primary purpose: PREVENTION

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).

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.

Eligibility 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

Primary outcomes:
measure: Fractional iron absorption
timeFrame: Baseline, 14 days after test meal administration
Secondary outcomes:
measure: Iron status
timeFrame: Baseline, 14 days after test meal administration
measure: Inflammatory status
timeFrame: Baseline, 14 days after test meal administration
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Fernfachhochschule Schweiz (FFHS) - Campus Gleisarena
Study officials:
affiliation: FFHS
name: Diego Moretti, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: