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临床试验/NCT04243187
NCT04243187Unknown不适用

Evaluation of Gastrointestinal Symptoms Following Chilean Native Beans Consumption

Natalia Jara0 个研究点目标入组 10 人开始时间: 2020年4月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
10
主要终点
Gastrointestinal symptoms

研究概览

简要总结

The oligosaccharide content (raffinose, stachyose, and verbascose) in legumes would be responsible for gastrointestinal symptoms (bloating, pain, meteorism), associated with its consumption.

We would evaluate consumption of 3 varieties of chilean native beans, and evaluate gastrointestinal symptoms produced along with expired H2 test, to correlate this with the amount of oligosaccharide content.

详细描述

Different varieties of legumes have different oligosaccharide contents, in a study in Poland, it is described that the content of stachyose between 3 varieties can be as different as 493 mg, 865 mg or 1200 mg per 100 grams of dried beans (Slupski 2014). Along with this it has been described that the different culinary preparations of the legumes decrease the anti-nutritional factors, so, when soaking for 6 hours it shows 16.5% of undigested sugars reaching the small intestine, but it is possible to digest 95% in the colon (Noah 1998). Soaking for 16 hours, decreases 85% phytate content, 84% tannin content, 25% raffinose content, 25% stachyose and 41% verbascose (Hurtado 2001).

The oligosaccharide content (raffinose, stachyose, and verbascose) would be responsible for gastrointestinal symptoms (bloating, pain, meteorism), associated with legume consumption.

This is because these sugars are galactooligosaccharides, which are not digested in the human intestine because it does not have an alpha-galactosidase enzyme (Hessels 2003).

In our study, 25 varieties of Chilean bean are being evaluated, with nutritional analysis, resulting in a variation between 18 and 25 grams of protein per 100 grams dry (unpublished data), the oligosaccharide content still pending will be evaluated for Select the 3 varieties that contain more proteins and less oligosaccharides.

These varieties with better nutritional "profile" will be selected, to be evaluated clinically.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Beans consumption on a regular basis (at least once a week)
  • Without obvious intolerance to beans intake

排除标准

  • Clinical history of recurrent gastrointestinal discomfort
  • Diagnosis of any gastrointestinal disease (gastroesophageal reflux, gastritis, irritable bowel syndrome, chronic diarrheal syndrome, etc.).
  • Meeting Rome IV criteria for diagnosis of irritable bowel syndrome.
  • Use of medications that affect gastrointestinal motility (omeprazole, metoclopramide, domperidone, loperamide, etc.) or antibiotics in the last month.

结局指标

主要结局

Gastrointestinal symptoms

时间窗: 4 months

We will evaluate the difference in the THE GASTROINTESTINAL SYMPTOM RATING SCALE (GSRS), with the intake of different native beans

次要结局

  • Exhaled Hydrogen Test(4 months)

研究者

发起方
Natalia Jara
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Natalia Jara

MD Msc

University of Chile

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