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| Name | Class |
|---|---|
| University of East Anglia | OTHER |
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A 3-way randomised cross-over study to test the hypothesis that combining either psyllium or methylcellulose to form a gel incorporating inulin will reduce gas production as compared to inulin given with a placebo, maltodextrin. Subjects will attend on 3 separate days separated by a minimum of one week an consume one of 3 test meals. Serial breath samples with be obtained to measure hydrogen and methane over the next 24 hours. Primary endpoint: Area under curve (AUC) from time 0-6 hours (AUC 0-6) of breath hydrogen (ppm.hour) after treatment intake. The investigators will also assess whole gut transit time using the blue muffin and correlate breath hydrogen production with in vitro fermentation results.
A 3-way randomised cross-over study to test the hypothesis that combining either psyllium or methylcellulose to form a gel incorporating inulin will reduce gas production as compared to inulin given with a placebo, maltodextrin. Subjects will attend on 3 separate days separated by a minimum of one week an consume one of 3 test meals. Serial breath samples with be obtained to measure hydrogen and methane over the next 24 hours.
Primary endpoint: Area under curve (AUC) from time 0-6 hours (AUC 0-6) of breath hydrogen (ppm.hour) after treatment intake. Whole gut transit time will be assessed from the time that stool turns blue after ingestion of a muffin labelled with blue food colouring.
Secondary endpoint:
The interventions will be dietary interventions, using all food grade materials (sugars and fibres) provided in commonly used doses:
Breath hydrogen will be correlated with in vitro carbohydrate fermentation profile assessed using stool samples collected before intervention
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Psyllium | Active Comparator | Psyllium 15 g+ inulin 15 gm in 375ml water |
|
| maltodextrin | Placebo Comparator | Maltodextrin 15 g + inulin 15 gm in 375 ml water |
|
| Methylcellulose | Experimental | Methylcellulose 15g + Inulin 15 g in 375 ml water |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psyllium | Dietary Supplement | 15g psyllium added to inulin solution to form a gel |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Breath hydrogen | AUC 0-6 hours after ingestion | 0-6 hoursafter ingestion |
| Measure | Description | Time Frame |
|---|---|---|
| Breath hydrogen | AUC 0-24 hours | 0-24 hours post ingestion |
| Breath methane | AUC 0-24 hours | 0-24 hours post ingestion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robin D Spiller, MD | University of Nottingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Clinical Research Centre | Nottingham | Nottinghamshire | NG7 2UH | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34353864 | Background | Gunn D, Abbas Z, Harris HC, Major G, Hoad C, Gowland P, Marciani L, Gill SK, Warren FJ, Rossi M, Remes-Troche JM, Whelan K, Spiller RC. Psyllium reduces inulin-induced colonic gas production in IBS: MRI and in vitro fermentation studies. Gut. 2022 May;71(5):919-927. doi: 10.1136/gutjnl-2021-324784. Epub 2021 Aug 5. | |
| 41636227 | Derived |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D011620 | Psyllium |
| D008747 | Methylcellulose |
| C008315 | maltodextrin |
| ID | Term |
|---|---|
| D010936 | Plant Extracts |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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3 way cross-over
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Test meals will have similar appearance and flavour
| Methylcellulose |
| Dietary Supplement |
15 g methylcellulose added to inulin solution to form a gel |
|
| Maltodextrin | Dietary Supplement | 15g maltodextrin added to inulin solution to form a gel |
|
| Transit time | whole gut transit time | Whole gut transit measured once before intervention |
| Reid JESJ, Alhasani AT, MacCalman T, Amor D, Aliyu AI, Modasia AA, Harris H, Warren FJ, Hoad C, Gowland PA, Yakubov GE, Crooks C, Corsetti M, Marciani L, Spiller RC. A randomised, placebo-controlled trial in healthy humans of modified cellulose or psyllium evaluating the role of gelation in altering colonic gas production during inulin co-administration. Food Funct. 2026 Feb 23;17(4):1794-1805. doi: 10.1039/d5fo03532e. |
| D004066 | Digestive System Diseases |
| D002482 |
| Cellulose |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |