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

NCT ID: NCT05510778

Last Updated: 2022-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-30
• Study Completion Date: 2021-12-22

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.

Conditions

Intestinal Gas

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Charcocaps

2 capsules 15 minutes before meal and 2 additional capsules 2 hours after meal

Group Type: EXPERIMENTAL

Charcocaps

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo

2 capsules 15 minutes before meal and 2 additional capsules 2 hours after meal

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

capsules containing \~250 mg cellulose

Interventions

Charcocaps

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

capsules containing \~250 mg cellulose

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

DSE Healthcare Solutions

UNKNOWN

Sponsor Role: collaborator

University of Memphis

OTHER

Sponsor Role: lead

Responsible Party

Richard Bloomer

Dean of the College of Health Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard Bloomer, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Memphis

Locations

Center for Nutraceutical and Dietary Supplement Research

Memphis, Tennessee, United States

Countries

United States

Other Identifiers

PRO-FY2022-9

Identifier Type: -

Identifier Source: org_study_id