An interventional study of Chilean Native Beans in Gastrointestinal Disease, Flatulence and Gastrointestinal Tolerance, sponsored by Natalia Jara. Status unknown. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-28.
Sponsored by Natalia Jara · Not applicable, Interventional, and Other
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.
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evaluated, with nutritional analysis, resulting in a variation between 18 and 25 grams of protein per 100 grams dry (unpublished data), the oligosaccharide content still pending will be evaluated for Select the 3 varieties that contain more proteins and less oligosaccharides.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.
628 studies on the registry are indexed under Gastrointestinal Diseases; 129 are open to participants now.
This study's planned enrollment of 10 is below the median of 77 across 422 interventional studies indexed under Gastrointestinal Diseases.
Browse Gastrointestinal Diseases studies →This is the only study on the registry with Natalia Jara as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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).
Gastrointestinal symptoms
We will evaluate the difference in the THE GASTROINTESTINAL SYMPTOM RATING SCALE (GSRS), with the intake of different native beans
Time frame: 4 months
Gastrointestinal symptoms
We will evaluate the difference in the "bristol stool chart" with the intake of different native beans
Time frame: 4 months
Exhaled Hydrogen Test
We will evaluate the difference in the exhaled hydrogen test with the intake of different native beans
Time frame: 4 months
No study locations are listed for this record.
Plan to share: Yes — De-identified data for all participants will be available
Supporting information: Study protocol, Sap, Csr
No publications or documents are linked to this record.
This study is status unknown, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.