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

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

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.

Study Overview

• Status: Completed
• Conditions: Intestinal Gas
• Intervention / Treatment: Dietary supplement: Charcocaps; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38152
      • Center for Nutraceutical and Dietary Supplement Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Self-report of at least one of the following symptoms after eating meals rich in complex carbohydrates (such as beans):

  1. Abdominal bloating/pain/cramps
  2. 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Charcocaps; 2 capsules 15 minutes before meal and 2 additional capsules 2 hours after meal	Dietary supplement: Charcocaps; 250 mg capsules containing Activated charcoal, Gelatin, Titanium Dioxide, and Carmine
PLACEBO_COMPARATOR: Placebo; 2 capsules 15 minutes before meal and 2 additional capsules 2 hours after meal	Other: Placebo; capsules containing ~250 mg cellulose

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Memphis
• Collaborators: DSE Healthcare Solutions

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 30, 2021
• Primary Completion (ACTUAL): December 22, 2021
• Study Completion (ACTUAL): December 22, 2021

Study Registration Dates

• First Submitted: December 8, 2021
• First Submitted That Met QC Criteria: August 19, 2022
• First Posted (ACTUAL): August 22, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 22, 2022
• Last Update Submitted That Met QC Criteria: August 19, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Breath Hydrogen; Charcocaps; Intestinal gas
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Protective Agents; Antidotes; Charcoal
• Other Study ID Numbers: PRO-FY2022-9

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No