Gastrointestinal DiseaseNCT04243187
Evaluation of Gastrointestinal Symptoms Following Chilean Native Beans Consumption
A study testing Chilean Native Beans in people with Gastrointestinal Disease and Flatulence, run by Natalia Jara.
Trial summary
The oligosaccharide content (raffinose, stachyose, and verbascose) in legumes would be responsible for gastrointestinal symptoms (bloating, pain, meteorism), associated with its consumption. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Disease, Flatulence, Gastrointestinal Tolerance
- What is being tested?
- Chilean Native Beans
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2020to 31 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Beans consumption on a regular basis (at least once a week)
- Without obvious intolerance to beans intake
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Gastrointestinal Disease, Flatulence, Gastrointestinal Tolerance, Distension; Bowel, Bloating
- Being tested
- Chilean Native Beans
- Keywords
- phaseolus, symptoms, expired hydrogen, bloating, bean, tolerance, beans
- Medical subject headings
- Gastrointestinal Diseases, Flatulence, Dilatation, Pathologic, Spinocerebellar Ataxia 31
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chilean Native BeansOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Chilean Native Beans |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal symptoms
We will evaluate the difference in the THE GASTROINTESTINAL SYMPTOM RATING SCALE (GSRS), with the intake of different native beans
Measured: 4 months
Gastrointestinal symptoms
We will evaluate the difference in the "bristol stool chart" with the intake of different native beans
Measured: 4 months
Secondary outcomes (1)
Exhaled Hydrogen Test
We will evaluate the difference in the exhaled hydrogen test with the intake of different native beans
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start1 Apr 2020 (estimated)
- Primary completion31 Jul 2020 (estimated)
- Study completion31 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Natalia Jara
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Nutrición y Tecnología de los Alimentos
- Responsible party
- Sponsor-investigator, Natalia Jara, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04243187
- Sponsor's protocol ID
- Porotos
- Status last verified
- Jan 2020
- First submitted
- 23 Jan 2020
- Last updated
- 28 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data for all participants will be available
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Gastrointestinal Symptoms Following Chilean Native Beans Consumption
- ClinicalTrials.gov ID
- NCT04243187
- Acronym / sponsor ID
- Porotos
- Conditions
- Gastrointestinal Disease, Flatulence, Gastrointestinal Tolerance, Distension; Bowel, Bloating
- Keywords
- phaseolus, symptoms, expired hydrogen, bloating, bean, tolerance, beans
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Natalia JaraUniversity, hospital or other
- Collaborators
- Instituto de Nutrición y Tecnología de los Alimentos
- Study start
- 1 Apr 2020 (estimated)
- Primary completion
- 31 Jul 2020 (estimated)
- Study completion
- 31 Oct 2020 (estimated)
- First posted
- 28 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Clinical Study | Experimental | Other: Chilean Native Beans9 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Beans consumption on a regular basis (at least once a week)
- Without obvious intolerance to beans intake
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chilean Native BeansIn 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). | Other | Clinical Study |
Primary outcome
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
Gastrointestinal symptoms
Time frame: 4 months
We will evaluate the difference in the "bristol stool chart" with the intake of different native beans
1 secondary outcome
Exhaled Hydrogen Test
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2020.
- Individual participant dataSharing planned: Yes. De-identified data for all participants will be available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Chilean Native Beans in people with Gastrointestinal Disease and Flatulence, run by Natalia Jara.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Natalia M Jara, MD (+56993499361, Nmjara@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastrointestinal symptoms (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2020.