Effects of CharcoCaps® (Activated Charcoal) vs. Placebo on Intestinal Gas Production
- Conditions
- Intestinal Gas
- Interventions
- Other: PlaceboDietary Supplement: Charcocaps
- Registration Number
- NCT05510778
- Lead Sponsor
- University of Memphis
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
-
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)
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo Placebo 2 capsules 15 minutes before meal and 2 additional capsules 2 hours after meal Charcocaps Charcocaps 2 capsules 15 minutes before meal and 2 additional capsules 2 hours after meal
- Primary Outcome Measures
Name Time Method Gastrointestinal Symptoms Questionnaire 360 minutes post meal consumption 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
Breath Hydrogen 360 minutes post meal consumption Hydrogen measured in exhale using H2 Check Analyzer
Flatus events 360 minutes post meal consumption Self-reported number of flatus events each hour
- Secondary Outcome Measures
Name Time Method Concluding Questionnaire 60 minutes post meal consumption Questionnaire where subjects provide written feedback on their perceptions of the assigned condition
Trial Locations
- Locations (1)
Center for Nutraceutical and Dietary Supplement Research
🇺🇸Memphis, Tennessee, United States