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Evaluation of Gastrointestinal Symptoms Following Chilean Native Beans Consumption

N

Natalia Jara

Status

Unknown

Conditions

Flatulence
Gastrointestinal Disease
Bloating
Distension; Bowel
Gastrointestinal Tolerance

Treatments

Other: Chilean Native Beans

Study type

Interventional

Funder types

Other

Identifiers

NCT04243187
Porotos

Details and patient eligibility

About

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.

Full description

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evaluated, with nutritional analysis, resulting in a variation between 18 and 25 grams of protein per 100 grams dry (unpublished data), the oligosaccharide content still pending will be evaluated for Select the 3 varieties that contain more proteins and less oligosaccharides.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

Enrollment

10 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • 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.

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

Clinical Study
Experimental group
Description:
9 visits, once a week, for bean intake (80 grams of dried beans, soaked for 12 hours, cooked in new water for 1.5 - 2 hours. This is approximately 160 grams of cooked beans). Four varieties of beans (3 native and 1 commercial) will be analyzed, which will be consumed in duplicate by participants (8 visits). A ninth visit will be made to perform a exhaled hydrogen test with raffinose (5 grams), as a positive control.
Treatment:
Other: Chilean Native Beans

Trial contacts and locations

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Central trial contact

Natalia M Jara, MD

Data sourced from clinicaltrials.gov

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