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临床试验/NCT04793906
NCT04793906已完成不适用

Meals to Improve Absorption of Iron Supplements and Iron Status in Iron Deficient Women of Reproductive Age: a Randomized, Controlled Trial

Pennington Biomedical Research Center2 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2021年5月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
59
试验地点
2
主要终点
Iron status

研究概览

简要总结

One of the targeted objectives of Healthy People 2020 is to reduce iron deficiency among women of reproductive age (WRA). Consuming foods rich in iron and/or oral iron supplementation is typically recommended to improve iron status; however, global rates of iron deficiency remain high. Thus, nutritional strategies to improve/maintain iron status are warranted. Dietary iron is found in two different forms: heme and non-heme iron. Non-heme iron is found in plant-based sources and is commonly used as a supplement and food fortificant. Absorption of non-heme iron is low compared to heme iron, which is found in animal sources, such as beef. Studies have also demonstrated that beef contains an unidentified factor that stimulates the absorption of non-heme iron. The primary objective of the proposed study is to determine the effects of incorporating daily meals containing beef or plant-based alternative with or without an iron supplement on indicators of iron status in iron-deficient WRA.

研究设计

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

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Body mass index (BMI) falls within the normal weight or overweight range (18.5-29.9 kg/m^2)
  • Low iron stores (serum ferritin <25 μg/L)
  • Willing to refrain from smoking and >2 alcoholic drinks/week for the duration of the study period
  • Willing to refrain from vitamin and mineral supplementation for the duration of the study

排除标准

  • Currently smoking or vaping
  • Currently taking a medication that interferes with micronutrient metabolism
  • Unwilling to refrain from vitamin and mineral supplementation for the duration of the study
  • Restrictive diets (i.e., vegan or vegetarian diets)
  • Metabolic or cardiovascular abnormalities (e.g., kidney disease, diabetes, cardiovascular disease, etc.)
  • History of any disease or abnormality of the gastrointestinal tract including, but not limited to, diverticulosis, diverticulitis and inflammatory bowel disease, peptic ulcer disease, Crohn's disease, ulcerative colitis; or previous gastrointestinal surgery
  • Blood donation within 4 months of beginning the study
  • Abnormal blood clotting

结局指标

主要结局

Iron status

时间窗: Change from day 0 and day 56

Plasma ferritin, soluble transferrin receptor, transferrin saturation, hemoglobin and hematocrit will be measured to determine iron status. Changes in measures of iron status during the intervention will be compared between groups.

次要结局

  • Profile of Mood States (POMS)(Change from day 0 and day 56)
  • Appetite(Change from day 0 and day 56)
  • Plasma vitamin B-12(Change from day 0 and day 56)
  • Weight(Change from day 0 and day 56)
  • Blood pressure(Change from day 0 and day 56)
  • Metabolic biomarkers(Change from day 0 and day 56)
  • Plasma choline(Change from day 0 and day 56)
  • Body composition(Change from day 0 and day 56)
  • Plasma zinc(Change from day 0 and day 56)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stephen Hennigar

Assistant Professor

Pennington Biomedical Research Center

研究点 (2)

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