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Completed

NCT Number: NCT05510778

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Nutraceutical and Dietary Supplement Research

Memphis, Tennessee, 38152, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Charcocaps

Dietary Supplement

250 mg capsules containing Activated charcoal, Gelatin, Titanium Dioxide, and Carmine

Placebo

Other

capsules containing ~250 mg cellulose

Primary outcomes

  1. Breath Hydrogen

    Time frame: 0 minutes before chili meal consumed (baseline)

    Hydrogen measured in exhale using H2 Check Analyzer

  2. Breath Hydrogen

    Time frame: 30 minutes post meal consumption

    Hydrogen measured in exhale using H2 Check Analyzer

  3. Breath Hydrogen

    Time frame: 60 minutes post meal consumption

    Hydrogen measured in exhale using H2 Check Analyzer

  4. Breath Hydrogen

    Time frame: 90 minutes post meal consumption

    Hydrogen measured in exhale using H2 Check Analyzer

  5. Breath Hydrogen

    Time frame: 120 minutes post meal consumption

    Hydrogen measured in exhale using H2 Check Analyzer

  6. Breath Hydrogen

    Time frame: 150 minutes post meal consumption

    Hydrogen measured in exhale using H2 Check Analyzer

  7. Breath Hydrogen

    Time frame: 180 minutes post meal consumption

    Hydrogen measured in exhale using H2 Check Analyzer

  8. Breath Hydrogen

    Time frame: 210 minutes post meal consumption

    Hydrogen measured in exhale using H2 Check Analyzer

  9. Breath Hydrogen

    Time frame: 240 minutes post meal consumption

    Hydrogen measured in exhale using H2 Check Analyzer

  10. Breath Hydrogen

    Time frame: 270 minutes post meal consumption

    Hydrogen measured in exhale using H2 Check Analyzer

  11. Breath Hydrogen

    Time frame: 300 minutes post meal consumption

    Hydrogen measured in exhale using H2 Check Analyzer

  12. Breath Hydrogen

    Time frame: 330 minutes post meal consumption

    Hydrogen measured in exhale using H2 Check Analyzer

  13. Breath Hydrogen

    Time frame: 360 minutes post meal consumption

    Hydrogen measured in exhale using H2 Check Analyzer

  14. Gastrointestinal Symptoms Questionnaire

    Time frame: baseline

    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

  15. Gastrointestinal Symptoms Questionnaire

    Time frame: 30 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

  16. Gastrointestinal Symptoms Questionnaire

    Time frame: 60 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

  17. Gastrointestinal Symptoms Questionnaire

    Time frame: 90 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

  18. Gastrointestinal Symptoms Questionnaire

    Time frame: 120 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

  19. Gastrointestinal Symptoms Questionnaire

    Time frame: 150 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

  20. Gastrointestinal Symptoms Questionnaire

    Time frame: 180 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

  21. Gastrointestinal Symptoms Questionnaire

    Time frame: 210 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

  22. Gastrointestinal Symptoms Questionnaire

    Time frame: 240 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

  23. Gastrointestinal Symptoms Questionnaire

    Time frame: 270 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

  24. Gastrointestinal Symptoms Questionnaire

    Time frame: 300 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

  25. Gastrointestinal Symptoms Questionnaire

    Time frame: 330 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

  26. Gastrointestinal Symptoms Questionnaire

    Time frame: 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

  27. Flatus events

    Time frame: baseline

    Self-reported number of flatus events each hour

  28. Flatus events

    Time frame: 60 minutes post meal consumption

    Self-reported number of flatus events each hour

  29. Flatus events

    Time frame: 120 minutes post meal consumption

    Self-reported number of flatus events each hour

  30. Flatus events

    Time frame: 180 minutes post meal consumption

    Self-reported number of flatus events each hour

  31. Flatus events

    Time frame: 240 minutes post meal consumption

    Self-reported number of flatus events each hour

  32. Flatus events

    Time frame: 300 minutes post meal consumption

    Self-reported number of flatus events each hour

  33. Flatus events

    Time frame: 360 minutes post meal consumption

    Self-reported number of flatus events each hour

Secondary outcomes

  1. Concluding Questionnaire

    Time frame: 60 minutes post meal consumption

    Questionnaire where subjects provide written feedback on their perceptions of the assigned condition

Sponsors and collaborators

Lead sponsor

University of Memphis

Other

Collaborators

  • DSE Healthcare Solutions

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 22, 2022
Registry last updated
Aug 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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