Clinical trial NCT04243187: Evaluation of Gastrointestinal Symptoms Following Chilean Native Beans Consumption
Official title: Evaluation of Gastrointestinal Symptoms Following Chilean Native Beans Consumption
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastrointestinal Disease
Flatulence
Gastrointestinal Tolerance
Distension; Bowel
Bloating
Keywords: phaseolus
symptoms
expired hydrogen
bloating
bean
tolerance
beans
Lead sponsor: University of Chile
Sponsor class: OTHER
Collaborators: name: Instituto de Nutrición y Tecnología de los Alimentos
First posted: 2020-01-28
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 10 subjects, 8 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 by duplicate for participants (8 visits).

A ninth visit will be made to perform a exhaled hydrogen test with raffinose (5 grams), as a positive control.
Primary purpose: OTHER

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Gastrointestinal symptoms
timeFrame: 4 months
measure: Gastrointestinal symptoms
timeFrame: 4 months
Secondary outcomes:
measure: Exhaled Hydrogen Test
timeFrame: 4 months
Other outcomes:
Locations:
Study officials:
References: