Evaluation of Gastrointestinal Symptoms Following Chilean Native Beans Consumption

Gastrointestinal Disease Clinical Trial

Official title:

Evaluation of Gastrointestinal Symptoms Following Chilean Native Beans Consumption

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04243187
• Other study ID #: Porotos
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2020
• Est. completion date: October 31, 2020

Study information

• Verified date: January 2020
• Source: University of Chile
• Contact: Natalia M Jara, MD
• Phone: +56993499361
• Email: Nmjara[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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evaluated, with nutritional analysis, resulting in a variation between 18 and 25 grams of protein per 100 grams dry (unpublished data), the oligosaccharide content still pending will be evaluated for Select the 3 varieties that contain more proteins and less oligosaccharides.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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: October 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bloating
• Digestive System Diseases
• Distension; Bowel
• Flatulence
• Gastrointestinal Disease
• Gastrointestinal Diseases
• Gastrointestinal Tolerance

Intervention

Other:
• Chilean Native Beans
In each visit the participant would have to: Fill a survey of gastrointestinal symptoms and basal bowel movements ("THE GASTROINTESTINAL SYMPTOM RATING SCALE (GSRS)) Fill a survey of food consumption Bean plate intake Expired hydrogen test, which consists of exhaling air in a syringe every 20 minutes for 12 times (4 hours in total). During this time the participant can do quiet activities (not physical activity). Fill surveys of gastrointestinal symptoms (online or on paper), during the hydrogen test, at 12 and 24 hours (3 times). During this time (1 day before and 2 days later) the participant cannot eat other bloating foods (legumes, cauliflower, broccoli, lettuce, cabbage, artichokes, onions, topinambur and others described in the food survey).

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Natalia Jara	Instituto de Nutrición y Tecnología de los Alimentos

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastrointestinal symptoms	We will evaluate the difference in the THE GASTROINTESTINAL SYMPTOM RATING SCALE (GSRS), with the intake of different native beans	4 months
Primary	Gastrointestinal symptoms	We will evaluate the difference in the "bristol stool chart" with the intake of different native beans	4 months
Secondary	Exhaled Hydrogen Test	We will evaluate the difference in the exhaled hydrogen test with the intake of different native beans	4 months