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临床试验/NCT03762148
NCT03762148已完成不适用

The Effect of Prebiotics on Iron Absorption in Women With Low Iron Stores: Determination of a Dose-dependent Effect of Galacto-oligosaccharides on Iron Absorption, With and Without Addition of Ascorbic Acid

Isabelle Herter-Aeberli2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2019年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
46
试验地点
2
主要终点
fractional iron absorption

研究概览

简要总结

Iron deficiency is still the most common and widespread nutritional disorder in the world according to WHO.

In a recent iron absorption study in adult women with low iron stores in our lab (publication under review), we found that 15 g of GOS given with an iron supplement in the form of iron fumarate acutely increased iron absorption when given with water and a bread based meal. The dose of 15 g of GOS was tolerated well by the participants. As a follow up to the study mentioned above, we want to investigate: 1) if acute iron absorption is affected by lower doses of GOS; 2) whether this acute effect occurs for other commonly used iron compounds as well, such as iron sulphate and iron phosphate; and 3) if there are potential interactions on absorption with other enhancers of iron absorption, such as vitamin c.

详细描述

Iron is an important mineral in our body and fulfills essential functions such as for example oxygen transport from the lungs to the tissues. Iron deficiency is still the most common and widespread nutritional disorder in the world according to WHO. Common iron supplements all have their limitations in terms of availability and compatibility. Prebiotic fibers, such as galacto-oligosaccharides (GOS), selectively enhance growth of beneficial colonic bacteria. Prebiotics in general enhance the production of short-chain fatty acids (SCFAs) and thereby decrease luminal pH. Through the reduction in pH, prebiotics can enhance absorption of minerals such as calcium and magnesium and they have been proposed to potentially improve iron absorption.

In a recent iron absorption study in adult women with low iron stores in our lab (publication under review), we found that 15 g of GOS given with an iron supplement in the form of iron fumarate acutely increased iron absorption when given with water and a bread based meal. The dose of 15 g of GOS was tolerated well by the participants. As a follow up to the study mentioned above, we want to investigate: 1) if acute iron absorption is affected by lower doses of GOS; 2) whether this acute effect occurs for other commonly used iron compounds as well, such as iron sulphate and iron phosphate; and 3) if there are potential interactions on absorption with other enhancers of iron absorption, such as vitamin c.

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
Double (Participant, Investigator)

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, 18 to 45 years old
  • SF levels <30 µg/L
  • Normal body Mass Index (18.5-24.9 kg/m2)
  • Body weight <70 kg
  • Signed informed consent

排除标准

  • Severe anaemia (Hb < 80 g/L)
  • Elevated CRP >10.0 mg/L
  • Any metabolic, gastrointestinal kidney or chronic disease such as diabetes, renal failure, hepatic dysfunction, hepatitis, hypertension, cancer or cardiovascular diseases (according to the participants own statement)
  • Continuous/long-term use of medication during the whole studies (except for contraceptives)
  • Consumption of mineral and vitamin supplements within 2 weeks prior to 1st supplement administration, including pre- and-or probiotics supplements (excluding foods and beverages with life cultures such as yoghurt, raw milk cheese and kombucha)
  • Blood transfusion, blood donation or significant blood loss (accident, surgery) over the past 4 months
  • Difficulties with blood sampling
  • Use of antibiotics over the past month
  • Known hypersensitivity to iron supplements in the given amount, GOS, or lactose
  • Women who are pregnant or breast feeding
  • Women who intend become pregnant during the course of the study
  • Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, inject-able, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases
  • Known or suspected non-compliance, drug or alcohol (more than 2 drinks/day) abuse -
  • Smokers (> 1 cigarette per week)
  • Inability to follow the procedures of the study, e.g. due to language problems, self-- reported psychological disorders, etc. of the participant
  • Enrollment of the investigator, his/her family members, employees and other dependent persons

研究组 & 干预措施

ferric pyrophosphate

Experimental

labelled iron as ferric pyrophosphate

干预措施: ferric pyrophosphate (Dietary Supplement)

ferrous fumarate + Vitamin C

Experimental

labelled iron as ferrous fumarate + Vitamin C

干预措施: ferrous fumarate + Vitamin C (Dietary Supplement)

ferrous fumarate + 3.5 g GOS

Experimental

labelled iron as ferrous fumarate + prebiotics in the form of 3.5 g GOS

干预措施: ferrous fumarate + 3.5 g GOS (Dietary Supplement)

ferrous fumarate + 7 g GOS

Experimental

labelled iron as ferrous fumarate + prebiotics in the form of 7 g GOS

干预措施: ferrous fumarate + 7 g GOS (Dietary Supplement)

ferrous sulphate + 15 g GOS

Experimental

labelled iron as ferrous sulphate + prebiotics in the form of 15 g GOS

干预措施: ferrous sulphate + 15 g GOS (Dietary Supplement)

ferric pyrophosphate + 15 g GOS

Experimental

labelled iron as ferric pyrophosphate + prebiotics in the form of 15 g GOS

干预措施: ferric pyrophosphate + 15 g GOS (Dietary Supplement)

ferrous fumarate + 7 g GOS + Vitamin C

Experimental

labelled iron as ferrous fumarate + prebiotics in the form of 7 g GOS + Vitamin C

干预措施: ferrous fumarate + 7 g GOS + Vitamin C (Dietary Supplement)

ferrous sulphate

Experimental

labelled iron as ferrous sulphate

干预措施: ferrous sulphate (Dietary Supplement)

ferrous fumarate

Experimental

labelled iron as ferrous fumarate

干预措施: ferrous fumarate (Dietary Supplement)

结局指标

主要结局

fractional iron absorption

时间窗: 2 months

Fractional iron absorption will be calculated based on the shift of the iron isotope ratios in the collected blood samples after the administration of several isotopically labelled iron supplements.Fractional iron absorption will be measured as erythrocyte incorporation of the naturally occurring iron forms with different masses used to label the iron supplements.

次要结局

未报告次要终点

研究者

发起方
Isabelle Herter-Aeberli
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Isabelle Herter-Aeberli

PhD

Swiss Federal Institute of Technology

研究点 (2)

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