LINDA: Iron Absorption From Naturally Dephytinized Legumes

Sponsor

Diego Moretti (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06032832

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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). This study compares the fractional iron absorption (FIA) of the 1) soy protein concentrate meat analog and 2) Farinata made from chickpea flour, both with and without 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 without dephytinization. In addition, this study will compare the FIA in Farinata, a traditional Italian dish prepared using chickpea flour, both with and without dephytinization.

Condition or Disease	Intervention/Treatment	Phase
Iron Deficiencies	Other: soy protein concentrate-meat analog Other: soy protein concentrate-meat analog_dephytinization Other: Farinata Other: Farinata_dephytinization	N/A

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 protein and chickpea flour with and without dephytinization 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

Study Type:

Interventional

Anticipated Enrollment :

22 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Randomized control trial, cross-overRandomized control trial, cross-over

Masking:

Single (Participant)

Masking Description:

Test meals will be randomized and served to participants. Participants will not know or taste the differences of dephytinization in soy protein concentrate or in chickpea.

Primary Purpose:

Prevention

Official Title:

The Effect of Dephytinization on Iron Absorption From a Soy Protein Based Meat Analog and Chickpea-farinata: a Randomized Study in Young Women

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Soy protein concentrate meat analog Meat analog made from soy protein concentrate contains 57Fe as ferrous sulfate. All participants will consume this test meal.	Other: soy protein concentrate-meat analog Baked Meat analogs-soy protein concentrate containing 57Fe as ferrous sulfate
Experimental: Soy protein concentrate meat analog without phytic acid 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.	Other: soy protein concentrate-meat analog_dephytinization Baked dephytinized_Meat analogs-soy protein concentrate containing 58Fe as ferrous sulfate
Experimental: Farinata_chickpea flour Farinata (thin pancake) made from chickpea flour contains 57Fe as ferrous sulfate. All participants will consume this test meal.	Other: Farinata Pancake made from chickpea flour contains 57Fe as ferrous sulfate
Experimental: Farinata_chickpea flour without phytic acid Farinata (thin pancake) made from chickpea flour that was removed phytic acid (dephytinization) contains 58Fe as ferrous sulfate. All participants will consume this test meal.	Other: Farinata_dephytinization Pancake made from dephytinized chickpea flour contains 58Fe as ferrous sulfate.

Outcome Measures

Primary Outcome Measures

Fractional iron absorption [Baseline, 14 day after test meal administration]
The fraction of absorbed iron from isotropic iron contain in the testmeal. This fractional iron absorption will be measure from blood sample after 14 day of test meal administration

Secondary Outcome Measures

Iron status [Baseline, 14 day after test meal administration]
Hemoglobin (Hb), plasma ferritin (PF), and serum soluble transferrin receptor (sTfR)
Inflammatory status [Baseline, 14 day after test meal administration]
Alpha-1-acid glycoprotein (AGP), C-reactive protein (CRP)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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