Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of Gastrointestinal Symptoms Following Chilean Native Beans Consumption

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04243187
Recruitment Status : Not yet recruiting
First Posted : January 28, 2020
Last Update Posted : January 28, 2020
Sponsor:
Collaborator:
Instituto de Nutrición y Tecnología de los Alimentos
Information provided by (Responsible Party):
Natalia Jara, University of Chile

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.


Condition or disease Intervention/treatment Phase
Gastrointestinal Disease Flatulence Gastrointestinal Tolerance Distension; Bowel Bloating Other: Chilean Native Beans Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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.

Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation of Gastrointestinal Symptoms Following Chilean Native Beans Consumption
Estimated Study Start Date : April 1, 2020
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : October 31, 2020

Arm Intervention/treatment
Experimental: Clinical Study

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

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).




Primary Outcome Measures :
  1. Gastrointestinal symptoms [ Time Frame: 4 months ]
    We will evaluate the difference in the THE GASTROINTESTINAL SYMPTOM RATING SCALE (GSRS), with the intake of different native beans

  2. Gastrointestinal symptoms [ Time Frame: 4 months ]
    We will evaluate the difference in the "bristol stool chart" with the intake of different native beans


Secondary Outcome Measures :
  1. Exhaled Hydrogen Test [ Time Frame: 4 months ]
    We will evaluate the difference in the exhaled hydrogen test with the intake of different native beans



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04243187


Contacts
Layout table for location contacts
Contact: Natalia M Jara, MD +56993499361 Nmjara@gmail.com

Sponsors and Collaborators
Natalia Jara
Instituto de Nutrición y Tecnología de los Alimentos
Layout table for additonal information
Responsible Party: Natalia Jara, MD Msc, University of Chile
ClinicalTrials.gov Identifier: NCT04243187    
Other Study ID Numbers: Porotos
First Posted: January 28, 2020    Key Record Dates
Last Update Posted: January 28, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data for all participants will be available
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: 6 month after completion of the study
Access Criteria: data access requests will we analyzed by the principal investigator.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Natalia Jara, University of Chile:
phaseolus
symptoms
expired hydrogen
bloating
bean
tolerance
beans
Additional relevant MeSH terms:
Layout table for MeSH terms
Gastrointestinal Diseases
Flatulence
Digestive System Diseases
Signs and Symptoms, Digestive
Signs and Symptoms