Effects of CharcoCaps® (Activated Charcoal) vs. Placebo on Intestinal Gas Production
Condition: Intestinal Gas
Study type: Interventional

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.
    

Intervention name(s): Charcocaps; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 250 mg capsules containing Activated charcoal, Gelatin, Titanium Dioxide, and Carmine; capsules containing ~250 mg cellulose
Intervention MeSH terms: Charcoal
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: double-blind, placebo controlled, cross-over
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Charcocaps; Intestinal gas; Breath Hydrogen