Evaluation of Gastrointestinal Symptoms Following Chilean Native Beans Consumption

NCT04243187 | Unknown DMC

• 1 other identifier: Porotos
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gastrointestinal Disease; Flatulence; Gastrointestinal Tolerance; Distension; Bowel; Bloating

Keywords

phaseolus; symptoms; expired hydrogen; bloating; bean; tolerance; beans

Outcome Measures

Primary Outcomes (2)

• Gastrointestinal symptoms

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

  4 months

• Gastrointestinal symptoms

  We will evaluate the difference in the "bristol stool chart" with the intake of different native beans

  4 months

Secondary Outcomes (1)

• Exhaled Hydrogen Test

  4 months

Study Arms (1)

Clinical Study

EXPERIMENTAL

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.

Other: Chilean Native Beans

Interventions

Chilean Native Beans OTHER

In each visit the participant would have to: 1. Fill a survey of gastrointestinal symptoms and basal bowel movements ("THE GASTROINTESTINAL SYMPTOM RATING SCALE (GSRS)) 2. Fill a survey of food consumption 3. Bean plate intake 4. 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). 5. 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).

Clinical Study

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Natalia Jara: lead
• Instituto de Nutrición y Tecnología de los Alimentos: collaborator

MeSH Terms

Conditions

Gastrointestinal Diseases; Flatulence; Dilatation, Pathologic; Spinocerebellar Ataxia 31

Condition Hierarchy (Ancestors)

Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathological Conditions, Anatomical

Central Study Contacts

Natalia M Jara, MD

CONTACT

+56993499361; Nmjara@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD Msc

Model Details: 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.

Study Record Dates

• First Submitted: January 23, 2020
• First Posted: January 28, 2020
• Study Start: April 1, 2020
• Primary Completion: July 31, 2020
• Study Completion: October 31, 2020
• Last Updated: January 28, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 6 month after completion of the study
• Access Criteria: data access requests will we analyzed by the principal investigator.