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临床试验/NCT06032832
NCT06032832已完成不适用

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

Diego Moretti2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2025年4月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
19
试验地点
2
主要终点
Fractional iron absorption

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Single (Participant)

盲法说明

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

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Female aged between 18-45 y old
  • Plasma ferritin < 30 microgram/L
  • BMI 18.5-25.0
  • Weight < 65 kg
  • Signed informed consent

排除标准

  • 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
  • celiac disease or gluten intolerance
  • Vegetarian or vegan dietary regimen

结局指标

主要结局

Fractional iron absorption

时间窗: Baseline, 14 days after test meal administration

The fraction of absorbed iron from isotopic iron contained in the test meal. This fractional iron absorption will be measured from blood sample after 14 days from test meal administration

次要结局

  • Iron status(Baseline, 14 days after test meal administration)
  • Inflammatory status(Baseline, 14 days after test meal administration)

研究者

发起方
Diego Moretti
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Diego Moretti

Prof.Dr. Diego Moretti

Swiss Distance University of Applied Sciences

研究点 (2)

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