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

NCT05510778 | Completed

• 1 other identifier: PRO-FY2022-9
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Intestinal Gas

Keywords

Charcocaps; Intestinal gas; Breath Hydrogen

Outcome Measures

Primary Outcomes (33)

• 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 Outcomes (1)

• Concluding Questionnaire

  60 minutes post meal consumption

Study Arms (2)

Charcocaps

EXPERIMENTAL

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

Dietary Supplement: Charcocaps

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Charcocaps DIETARY_SUPPLEMENT

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

Charcocaps

Placebo OTHER

capsules containing \~250 mg cellulose

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Memphis: lead
• DSE Healthcare Solutions: collaborator

Study Sites (1)

Center for Nutraceutical and Dietary Supplement Research

Memphis, Tennessee, 38152, United States

Location

MeSH Terms

Conditions

Anthrax

Interventions

Charcoal

Condition Hierarchy (Ancestors)

Bacillaceae Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Carbon; Elements; Inorganic Chemicals

Study Officials

• Richard Bloomer, PhD

  University of Memphis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Charcocaps and placebo capsules are similar in appearance and provided to investigators pre-masked (A and B).
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean of the College of Health Sciences

Model Details: double-blind, placebo controlled, cross-over

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: August 22, 2022
• Study Start: September 30, 2021
• Primary Completion: December 22, 2021
• Study Completion: December 22, 2021
• Last Updated: August 22, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)