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
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
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
NCT ID
NCT04243187
First Posted
January 23, 2020
Last Updated
January 23, 2020
Sponsor
Natalia Jara
Collaborators
Instituto de Nutrición y Tecnología de los Alimentos
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.
Learn more about this trial
Evaluation of Gastrointestinal Symptoms Following Chilean Native Beans Consumption
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