NCT05510778|Completed
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Sponsor study identifier
interventional
20
1 country
1
Study Start
September 30, 2021
Actual (reported)Primary Completion
December 22, 2021
Actual (reported)Study Completion
December 22, 2021
Actual (reported)Consumption of a high-fiber diet, often consisting of beans and vegetables, is recommended for improvements in overall health. Unfortunately, intake of the above-mentioned foods is often associated with a significant increase in intestinal gas production. In addition to gas, abdominal bloating, cramping, and associated symptoms can prove unacceptable-leading people to limit or abandon the consumption of bean-rich meals. In an attempt to reduce gas formation and the ensuing symptoms, various anti-gas products have been developed and are sold on the market. One such non-prescription product is Beano, a solution of the enzyme alpha-galactosidase. In addition to alpha-galactosidase, activated charcoal has also been used successfully in some, but not all, studies and may be a good option for certain individuals. CharcoCaps® is a branded form of activated charcoal that has been sold for several years.That said, no controlled studies have been conducted using CharcoCaps®. This study will investigate the effects of ingesting CharcoCaps® before and following the meal on the amount of gas produced, the number of flatus events, and associated symptoms of GI distress during the 6-hour post meal ingestion period.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 22, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 30, 2021
Actual (reported)December 8, 2021
Actual (reported)December 22, 2021
Actual (reported)December 22, 2021
Actual (reported)August 22, 2022
Actual (reported)Breath Hydrogen
Hydrogen measured in exhale using H2 Check Analyzer
0 minutes before chili meal consumed (baseline)
Breath Hydrogen
Hydrogen measured in exhale using H2 Check Analyzer
30 minutes post meal consumption
Breath Hydrogen
Hydrogen measured in exhale using H2 Check Analyzer
60 minutes post meal consumption
Breath Hydrogen
Hydrogen measured in exhale using H2 Check Analyzer
90 minutes post meal consumption
Breath Hydrogen
Hydrogen measured in exhale using H2 Check Analyzer
120 minutes post meal consumption
Breath Hydrogen
Concluding Questionnaire
60 minutes post meal consumption
2 capsules 15 minutes before meal and 2 additional capsules 2 hours after meal
2 capsules 15 minutes before meal and 2 additional capsules 2 hours after meal
250 mg capsules containing Activated charcoal, Gelatin, Titanium Dioxide, and Carmine
capsules containing \~250 mg cellulose
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Center for Nutraceutical and Dietary Supplement Research
Memphis, Tennessee, 38152, United States
Richard Bloomer, PhD
University of Memphis
20 participants (actual enrollment reported by the registry).
First Submitted
December 8, 2021
First Posted
August 22, 2022
Study Start
Hydrogen measured in exhale using H2 Check Analyzer
150 minutes post meal consumption
Breath Hydrogen
Hydrogen measured in exhale using H2 Check Analyzer
180 minutes post meal consumption
Breath Hydrogen
Hydrogen measured in exhale using H2 Check Analyzer
210 minutes post meal consumption
Breath Hydrogen
Hydrogen measured in exhale using H2 Check Analyzer
240 minutes post meal consumption
Breath Hydrogen
Hydrogen measured in exhale using H2 Check Analyzer
270 minutes post meal consumption
Breath Hydrogen
Hydrogen measured in exhale using H2 Check Analyzer
300 minutes post meal consumption
Breath Hydrogen
Hydrogen measured in exhale using H2 Check Analyzer
330 minutes post meal consumption
Breath Hydrogen
Hydrogen measured in exhale using H2 Check Analyzer
360 minutes post meal consumption
Gastrointestinal Symptoms Questionnaire
Questionnaire that subject self-report the severity of gastrointestinal symptoms using a scale of 0 (no symptoms) to 10 (severe symptoms) for Bloating, Flatulence, Abdominal Rumblings, Abdominal Pain/Cramping, Stomach Fullness, Nausea, and Overall physical discomfort
baseline
Gastrointestinal Symptoms Questionnaire
Questionnaire that subject self-report the severity of gastrointestinal symptoms using a scale of 0 (no symptoms) to 10 (severe symptoms) for Bloating, Flatulence, Abdominal Rumblings, Abdominal Pain/Cramping, Stomach Fullness, Nausea, and Overall physical discomfort
30 minutes post meal consumption
Gastrointestinal Symptoms Questionnaire
Questionnaire that subject self-report the severity of gastrointestinal symptoms using a scale of 0 (no symptoms) to 10 (severe symptoms) for Bloating, Flatulence, Abdominal Rumblings, Abdominal Pain/Cramping, Stomach Fullness, Nausea, and Overall physical discomfort
60 minutes post meal consumption
Gastrointestinal Symptoms Questionnaire
Questionnaire that subject self-report the severity of gastrointestinal symptoms using a scale of 0 (no symptoms) to 10 (severe symptoms) for Bloating, Flatulence, Abdominal Rumblings, Abdominal Pain/Cramping, Stomach Fullness, Nausea, and Overall physical discomfort
90 minutes post meal consumption
Gastrointestinal Symptoms Questionnaire
Questionnaire that subject self-report the severity of gastrointestinal symptoms using a scale of 0 (no symptoms) to 10 (severe symptoms) for Bloating, Flatulence, Abdominal Rumblings, Abdominal Pain/Cramping, Stomach Fullness, Nausea, and Overall physical discomfort
120 minutes post meal consumption
Gastrointestinal Symptoms Questionnaire
Questionnaire that subject self-report the severity of gastrointestinal symptoms using a scale of 0 (no symptoms) to 10 (severe symptoms) for Bloating, Flatulence, Abdominal Rumblings, Abdominal Pain/Cramping, Stomach Fullness, Nausea, and Overall physical discomfort
150 minutes post meal consumption
Gastrointestinal Symptoms Questionnaire
Questionnaire that subject self-report the severity of gastrointestinal symptoms using a scale of 0 (no symptoms) to 10 (severe symptoms) for Bloating, Flatulence, Abdominal Rumblings, Abdominal Pain/Cramping, Stomach Fullness, Nausea, and Overall physical discomfort
180 minutes post meal consumption
Gastrointestinal Symptoms Questionnaire
Questionnaire that subject self-report the severity of gastrointestinal symptoms using a scale of 0 (no symptoms) to 10 (severe symptoms) for Bloating, Flatulence, Abdominal Rumblings, Abdominal Pain/Cramping, Stomach Fullness, Nausea, and Overall physical discomfort
210 minutes post meal consumption
Gastrointestinal Symptoms Questionnaire
Questionnaire that subject self-report the severity of gastrointestinal symptoms using a scale of 0 (no symptoms) to 10 (severe symptoms) for Bloating, Flatulence, Abdominal Rumblings, Abdominal Pain/Cramping, Stomach Fullness, Nausea, and Overall physical discomfort
240 minutes post meal consumption
Gastrointestinal Symptoms Questionnaire
Questionnaire that subject self-report the severity of gastrointestinal symptoms using a scale of 0 (no symptoms) to 10 (severe symptoms) for Bloating, Flatulence, Abdominal Rumblings, Abdominal Pain/Cramping, Stomach Fullness, Nausea, and Overall physical discomfort
270 minutes post meal consumption
Gastrointestinal Symptoms Questionnaire
Questionnaire that subject self-report the severity of gastrointestinal symptoms using a scale of 0 (no symptoms) to 10 (severe symptoms) for Bloating, Flatulence, Abdominal Rumblings, Abdominal Pain/Cramping, Stomach Fullness, Nausea, and Overall physical discomfort
300 minutes post meal consumption
Gastrointestinal Symptoms Questionnaire
Questionnaire that subject self-report the severity of gastrointestinal symptoms using a scale of 0 (no symptoms) to 10 (severe symptoms) for Bloating, Flatulence, Abdominal Rumblings, Abdominal Pain/Cramping, Stomach Fullness, Nausea, and Overall physical discomfort
330 minutes post meal consumption
Gastrointestinal Symptoms Questionnaire
Questionnaire that subject self-report the severity of gastrointestinal symptoms using a scale of 0 (no symptoms) to 10 (severe symptoms) for Bloating, Flatulence, Abdominal Rumblings, Abdominal Pain/Cramping, Stomach Fullness, Nausea, and Overall physical discomfort
360 minutes post meal consumption
Flatus events
Self-reported number of flatus events each hour
baseline
Flatus events
Self-reported number of flatus events each hour
60 minutes post meal consumption
Flatus events
Self-reported number of flatus events each hour
120 minutes post meal consumption
Flatus events
Self-reported number of flatus events each hour
180 minutes post meal consumption
Flatus events
Self-reported number of flatus events each hour
240 minutes post meal consumption
Flatus events
Self-reported number of flatus events each hour
300 minutes post meal consumption
Flatus events
Self-reported number of flatus events each hour
360 minutes post meal consumption
Contact the study team to confirm eligibility.
September 30, 2021
Actual (reported)Primary Completion
December 22, 2021
Actual (reported)Study Completion
December 22, 2021
Actual (reported)Last Updated
August 22, 2022
Record last verified: 2022-08
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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