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Evaluation of Gastrointestinal Symptoms Following Chilean Native Beans Consumption

Primary Purpose

Gastrointestinal Disease, Flatulence, Gastrointestinal Tolerance

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Chilean Native Beans
Sponsored by
Natalia Jara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Gastrointestinal Disease focused on measuring phaseolus, symptoms, expired hydrogen, bloating, bean, tolerance, beans

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Clinical Study

    Arm 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.

    Outcomes

    Primary Outcome Measures

    Gastrointestinal symptoms
    We will evaluate the difference in the THE GASTROINTESTINAL SYMPTOM RATING SCALE (GSRS), with the intake of different native beans
    Gastrointestinal symptoms
    We will evaluate the difference in the "bristol stool chart" with the intake of different native beans

    Secondary Outcome Measures

    Exhaled Hydrogen Test
    We will evaluate the difference in the exhaled hydrogen test with the intake of different native beans

    Full Information

    First Posted
    January 23, 2020
    Last Updated
    January 23, 2020
    Sponsor
    Natalia Jara
    Collaborators
    Instituto de Nutrición y Tecnología de los Alimentos
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04243187
    Brief Title
    Evaluation of Gastrointestinal Symptoms Following Chilean Native Beans Consumption
    Official Title
    Evaluation of Gastrointestinal Symptoms Following Chilean Native Beans Consumption
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 1, 2020 (Anticipated)
    Primary Completion Date
    July 31, 2020 (Anticipated)
    Study Completion Date
    October 31, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Natalia Jara
    Collaborators
    Instituto de Nutrición y Tecnología de los Alimentos

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gastrointestinal Disease, Flatulence, Gastrointestinal Tolerance, Distension; Bowel, Bloating
    Keywords
    phaseolus, symptoms, expired hydrogen, bloating, bean, tolerance, beans

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    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.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Clinical Study
    Arm Type
    Experimental
    Arm 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.
    Intervention Type
    Other
    Intervention Name(s)
    Chilean Native Beans
    Intervention Description
    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).
    Primary Outcome Measure Information:
    Title
    Gastrointestinal symptoms
    Description
    We will evaluate the difference in the THE GASTROINTESTINAL SYMPTOM RATING SCALE (GSRS), with the intake of different native beans
    Time Frame
    4 months
    Title
    Gastrointestinal symptoms
    Description
    We will evaluate the difference in the "bristol stool chart" with the intake of different native beans
    Time Frame
    4 months
    Secondary Outcome Measure Information:
    Title
    Exhaled Hydrogen Test
    Description
    We will evaluate the difference in the exhaled hydrogen test with the intake of different native beans
    Time Frame
    4 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Natalia M Jara, MD
    Phone
    +56993499361
    Email
    Nmjara@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    De-identified data for all participants will be available
    IPD Sharing Time Frame
    6 month after completion of the study
    IPD Sharing Access Criteria
    data access requests will we analyzed by the principal investigator.

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    Evaluation of Gastrointestinal Symptoms Following Chilean Native Beans Consumption

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