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临床试验/NCT04194567
NCT04194567已完成不适用

An Absorption Study in Young Women to Evaluate the Effect of Polyphenols on Iron Absorption From Ragi (Finger Millet) Using the Iron Isotopic Method

Swiss Federal Institute of Technology2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2019年11月4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
入组人数
22
试验地点
2
主要终点
Total Iron Absorption

研究概览

简要总结

In India, one of the fast growing countries, 53% of all women have anaemia as per the National Family Health Survey. A recently published study on the burden of disease in India concluded that the burden of Iron deficiency anaemia (IDA) is 3 times higher than the average globally for other geographies at a similar level of development, and that women are disproportionately affected. Finger Millet (Eleusine coracana), more commonly known as Ragi, is a type of a millet crop grown in India, is considerably rich in minerals and its micronutrient density is higher than that of the world's major cereal grains: rice and wheat. Ragi also contains different antinutrients such as phytates and polyphenols, which have been known to have an inhibiting effect on the absorption of iron. On an average, white finger millet contains 0.04-0.09% polyphenols and brown varieties have 0.08-3.47%. The dark variety of ragi is the most widely consumed type. The white ragi is the lesser consumed type. However, the levels of polyphenols, which inhibit the absorption of iron, are ten times lower in the white ragi as compared to the dark ragi. Thus, it is important to evaluate the extent of inhibition of the polyphenols on the iron absorption. This information would be beneficial for policy making and promotion of cultivation of the type of ragi that could be most effective for the consumers

详细描述

Finger Millet (Eleusine coracana), more commonly known as Ragi, is a type of a millet crop grown in India, including other countries especially in East Africa. Ragi has been perceived as a potential "super cereal" by the United States National Academies being one of the most nutritious among all major cereals. From the nutritional perspective, finger millet is considerably rich in minerals and its micronutrient density is higher than that of the world's major cereal grains: rice and wheat .

Millets (Ragi or finger millet and Jowar or sorghum) were consumed by 59% of rural and 28% of urban population in Karnataka. Ragi consumption was seen predominantly in south Karnataka with 27% of rural and 17% of urban population reporting consumption.

Ragi is the richest source of calcium among cereals with up to 10-fold higher calcium content than brown rice, wheat or maize and three times than that of milk. It is also rich in iron and fiber, making this crop more nutritive as compared to other most commonly used cereals. Finger millet is enriched in the essential amino acids like lysine and methionine which are important in human health and growth but remain absent from most other plant foods . In addition, it also contains useful amounts of the two polyunsaturated fatty acids- linoleic acid and α-linolenic acid , metabolized products of which facilitate normal development of the central nervous system. Despite the well-documented health benefits of finger millet, only a limited progress has been made in context to its nutraceutical applications as functional food. Although, it may have remained underutilized by the general population due to either unawareness or apprehension, its immense potential for enhancing the nutritional and therapeutic attributes by acting as functional food cannot be ignored.

Ragi also contains different antinutrients such as phytates and polyphenols, which have been known to have an inhibiting effect on the absorption of iron. On an average, white finger millet contains 0.04-0.09% polyphenols and brown varieties have 0.08-3.47% . It was found that found proto-catechuic acid (45.0 mg/100 g) is the major free phenolic acid in ragi. In another study of total phenolic compounds in finger millet, it was found to have 85% benzoic acid derivatives (gallic acid, protocatechuic acid, p-hydroxybenzoic acid, vanillic acid, syringic acid) while rest of the fraction were either cinnamic acid derivatives (ferulic acid, trans-cinnamic acid, p-coumaric acid, caffeic acid, sinapic acid) or flavonoids (quercetin, Proanthocyanidins like condensed tannins) . Among bound phenloic acids, ferulic and p-coumaric acid are the major fractions and account for 64-96 and 50-99% of total ferulic and p-coumaric acid content of finger millet grains, respectively.

The dark variety of ragi is the most widely consumed type. The white ragi is the lesser consumed type. However, the levels of polyphenols, which inhibit the absorption of iron, are ten times lower in the white ragi as compared to the dark ragi. Thus, it is important to evaluate the extent of inhibition of the polyphenols on the iron absorption. This information would be beneficial for policy making and promotion of cultivation of the type of ragi that could be most effective for the consumers

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
None

入排标准

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

入选标准

  • •Female, 18 to 40 years old
  • •Body weight up to 65 kg
  • •Normal Body Mass Index (18.5 - 25 kg/m2)
  • •Signed informed consent
  • •Plasma ferritin < 25 ng/ml
  • •Able to communicate in and comprehend English language
  • •Tasted and found the Ragi to be of acceptable taste and confirmed will to consume the test meals if enrolled in the study

排除标准

  • •Pregnancy (assessed by a urinary pregnancy test) / intention to become pregnant
  • •Lactating up to 6 weeks before study initiation
  • •Moderate or severe anaemia (Hb < 9.0 g/dL)
  • •Elevated CRP (> 5.0 mg/L)
  • •Any metabolic, gastrointestinal, kidney or chronic disease such as celiac disease, diabetes, hepatitis, hypertension, cancer or cardiovascular diseases (according to the participants own statement)
  • •Continuous/long-term use of medication during the whole study (except for contraceptives)
  • •Consumption of mineral and vitamin supplements within 2 weeks prior to first meal administration
  • •Blood transfusion, blood donation or significant blood loss (accident, surgery) within 4 months prior to first meal administration
  • •Earlier participation in a study using iron stable isotopes or participation in any clinical study within the last 30 days
  • •Participant who cannot be expected to comply with study protocol (e.g. not available on certain study appointments or difficulties with blood withdrawal)
  • •Inability to understand the information sheet and the informed consent form due to cognitive or language reasons

研究组 & 干预措施

Black Ragi

Experimental

During one week of the study, participants are to consume pancakes made from the dark variety of ragi.

干预措施: Black Ragi (Other)

White Ragi

Experimental

During the second week of the study, participants are to consume pancakes made from the white variety of ragi

干预措施: White Ragi (Other)

结局指标

主要结局

Total Iron Absorption

时间窗: 26th day of the study

Total iron absorption from the two ragi types will be compared by measuring the total iron absorbed from all the meals in the study

Fractional Iron absorption

时间窗: 26th day of the study

The fractional iron absrption will be compared in predefined comparisons from the two interventions products that are administered to the study participants

次要结局

  • C-Reactive Protein(screening (-1), baseline (day 1), last test meal consumption (day 26))
  • Body Iron stores(last test meal consumption (day 26))
  • Soluble transferrin receptor(last test meal consumption (day 26))
  • Hemoglobin(screening (-1), baseline (day 1), last test meal consumption (day 26))
  • Plasma ferritin(screening (-1), baseline (day 1), last test meal consumption (day 26))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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