Effects of CharcoCaps® (Activated Charcoal) vs. Placebo on Intestinal Gas Production

Study Overview
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Brief Summary
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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.

Detailed Description
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Consumption of a high-fiber diet, often consisting of beans and vegetables, is recommended for improvements in overall health. Adhering to such a dietary regimen is associated with weight management, as well as improvements in the blood lipid profile and glucose regulation (i.e., the prevention of type 2 diabetes). The end result is a lowering of the overall risk of cardio-metabolic disease . Unfortunately, intake of the above mentioned foods is often associated with a significant increase in intestinal gas production, which has been suggested to be upwards of 10x that of a non-gas producing diet. This can be both uncomfortable and embarrassing when in social situations. In particular, flatus events are increased as a result of consumption of a bean-rich diet, with large volumes of flatus produced shortly after the ingestion of meals (within a few hours). In addition to flatus, 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. This product has been reported to effectively lower gas production (as evidenced by flatus events) following the consumption of a meatless chili meal, with the greatest improvements noted between 4-6 hours post meal ingestion. 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. Activated charcoal is a fine, odorless powder formed from the destructive distillation of various organic materials, treated with substances such as steam or other chemicals at very high temperatures to increase its absorptive power. This agent is often described as a rigid sponge and has the ability to absorb many chemical substances, including gases. In fact, some have suggested that adding charcoal inside the seat cushions on airplanes may improve the flight experience for passengers, as released gas could be captured by the charcoal within the seats and reduce the odor. CharcoCaps® is a branded form of activated charcoal that has been sold for several years, is widely available (e.g., Amazon, Walgreens, CVS), and has received excellent reviews from end users with regards to its ability to reduce intestinal gas production. That said, no controlled studies have been conducted using CharcoCaps®. Therefore, the following study will be conducted using a double-blind, placebo controlled, cross-over design to determine the impact of CharcoCaps® to reduce gas production and associated symptoms following the ingestion of a bean-rich meal. The investigators hypothesize that ingestion of CharcoCaps® before and following the meal will reduce the amount of gas produced, the number of flatus events, as well as associated symptoms of GI distress during the 6-hour post meal ingestion period.

Official Title
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Effects of CharcoCaps® (Activated Charcoal) vs. Placebo on Intestinal Gas Production Assessed Using Breath Hydrogen and a Gastrointestinal Questionnaire

Conditions
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Intestinal Gas

Intervention / Treatment
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* Dietary Supplement: Charcocaps
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Self-report of at least one of the following symptoms after eating meals rich in complex carbohydrates (such as beans): Abdominal bloating/pain/cramps Flatulence/gas Willing to consume a meatless chili meal and steamed broccoli No consumption of alcohol-containing beverages within 24 hours of testing No consumption of caffeine-containing beverages within 24 hours of testing No strenuous exercise within 24 hours of testing Be able to fast overnight (>10 hrs) Exclusion Criteria: Diagnosed GI condition Diabetic Pregnant/lactating Self-reported active infection or illness of any kind Tobacco product user Hypersensitivity or allergy to any component of the supplement or chili (Activated charcoal, Gelatin, Titanium Dioxide, and Carmine, black beans, kidney beans, pinto beans, tomato puree, bell peppers, onion, sweet potato, chili powder, onion powder, garlic powder, salt, pepper, cumin, oregano, broccoli) Taking any anti-gas, or anti-flatulence medication or dietary supplements, or if taking only non-prescribed supplements/mediations, not willing to cease use of them during study period A regular consumer of bean meals (no more than once weekly)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: double-blind, placebo controlled, cross-over
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Charcocaps<br>2 capsules 15 minutes before meal and 2 additional capsules 2 hours after meal | Dietary Supplement: Charcocaps<br>* 250 mg capsules containing Activated charcoal, Gelatin, Titanium Dioxide, and Carmine<br>|
| Placebo Comparator: Placebo<br>2 capsules 15 minutes before meal and 2 additional capsules 2 hours after meal | Other: Placebo<br>* capsules containing  250 mg cellulose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concluding Questionnaire | Questionnaire where subjects provide written feedback on their perceptions of the assigned condition | 60 minutes post meal consumption | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Charcocaps, Intestinal gas, Breath Hydrogen