Effects of an Encapsulated Calcium Butyrate Dietary Supplement on Gut Health

NCT06397482 | Completed

• 1 other identifier: BIO-2314
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this single-arm pilot study is to investigate the effects of an encapsulated calcium butyrate dietary supplement on gastrointestinal (GI) health outcomes in healthy adults, including GI symptom severity (e.g., gas/flatulence and abdominal bloating), bowel habits (frequency and consistency), digestion-associated quality of life, and measures of GI permeability.

Conditions

Healthy; Gastrointestinal Discomfort

Keywords

Butyrate; Butyric Acid; Short-Chain Fatty Acid; Permeability

Outcome Measures

Primary Outcomes (1)

• Indigestion Symptom Severity

  Assessed by the Gastrointestinal Symptom Rating Scale (GSRS): minimum = 1 (no discomfort); maximum = 7 (very severe discomfort)

  Change from baseline (day 0) to end of each week (day 8, 15, 22, 29, 36, and 43)

Secondary Outcomes (8)

• Other Gastrointestinal Symptom Severity

  Change from baseline (day 0) to end of each week (day 8, 15, 22, 29, 36, and 43)

• Digestion-associated Quality of Life

  Change from baseline (day 0) to end of each week (day 8, 15, 22, 29, 36, and 43)

• Ease of Stool Passage

  Change from baseline (day 0) to end of intervention (day 43)

• Stool Consistency

  Change from baseline (day 0) to end of intervention (day 43)

• Intestinal Permeability Marker 1

  Change from baseline (day 0) to end of intervention (day 43)

Study Arms (1)

Encapsulated Calcium Butyrate

EXPERIMENTAL

Subjects will be instructed to consume one 600 mg capsule daily, on an empty stomach, at least 30 minutes before their first meal.

Dietary Supplement: Encapsulated Calcium Butyrate

Interventions

Encapsulated Calcium Butyrate DIETARY_SUPPLEMENT

Contains at minimum 35% butyric acid

Encapsulated Calcium Butyrate

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ≥18 to ≤60 years of age at visit 1.
• BMI ≥18.0 and \<32.0 kg/m2 at visit 1.
• A mean ≥3 (at least mild symptoms) in the indigestion domain from the Gastrointestinal Symptom Rating Scale (GSRS) at both visits 1 (day -8) and 2 (day 0).
• Habitually consumes a standard American diet as defined by a Diet ID diet quality score of ≤6 (\~60 on the Healthy Eating Index \[HEI\]-2015).
• Willing to abstain from alcohol consumption and vigorous exercise for 24 hours prior to and following visits 2 (day 0) and 4 (day 43).
• Non-user or former user (daily use; cessation ≥12 months) of tobacco or nicotine products (e.g., cigarette smoking, vaping, chewing tobacco) within 12 months of visit 1, and has no plans to begin use during the study period.
• Non-user or former user (daily use; cessation ≥12 months) of any marijuana or hemp products within 12 months of visit 1 and has no plans to use marijuana or hemp products during the study period.
• Willing to maintain habitual physical activity level throughout the duration of the study with the exception of the 24 h before and after visits 2 and 4 (days 0 and 43).
• Willing to maintain habitual dietary patterns throughout the duration of the study, including stable intake of current vitamins, minerals, supplements, and medications not interfering with study outcomes.
• Female subject who is willing to wear a tampon during the stool and urine collection if the collection occurs during menstruation.
• No health conditions that would prevent him/her from fulfilling the study requirements as judged by the Clinical Investigator based on medical history.
• Understands the study procedures and signs forms providing informed consent to participate in the study and authorizes the release of relevant protected health information to the Clinical Investigator.

You may not qualify if:

• Known sensitivity, intolerability, or allergy to any of the study products or their excipients.
• Abnormal laboratory test results of clinical significance at visit 1 (day -8), at the discretion of the Clinical Investigator. One re-test will be allowed on a separate day prior to visit 2 (day 0), for subjects with abnormal laboratory test results.
• Clinically important GI condition that would potentially interfere with the evaluation of the study product (e.g., inflammatory bowel disease, irritable bowel syndrome, Crohn's disease, celiac disease, history of surgery for weight loss, gastroparesis, and clinically significant lactose or gluten intolerance or other food or ingredient allergies).
• Pre-menopausal female subjects with an irregular menstrual cycle (regular cycle defined as 21 to 35 days in length for the last 3 months prior to visit 1).
• Recent (within 2 weeks of visit 1; day -8) history of an episode of acute GI illness such as nausea/vomiting or diarrhea (defined as ≥3 loose or liquid stools/d).
• Self-reported history (within 6 weeks of visit 1; day -8) of constipation (defined as fewer than three bowel movements per week).
• Uncontrolled and/or clinically important pulmonary (including uncontrolled asthma), cardiac (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), hepatic, renal, endocrine (including Type 1 and Type 2 diabetes mellitus), hematologic, immunologic, neurologic (such as Alzheimer's or Parkinson's disease), psychiatric (including depression and/or anxiety disorders) or biliary disorders. Conditions that are well-controlled or resolved will be assessed by the Clinical Investigator on a case-by-case basis.
• Uncontrolled hypertension (systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg) as defined by the blood pressure measured at visit 1 (day -8; section 6.3.1).
• Unstable use (initiation or change in dose) within 1 month of visit 1 (day -8) of FDA-approved medications for hypertension.
• History or presence of cancer in the prior 2 years, except for non-melanoma skin cancer.
• Major trauma or any other surgical event within 3 months of visit 1 (day -8).
• Signs or symptoms of an active infection of clinical relevance within 5 days of visit 1 (day -8). The visit may be rescheduled once all signs and symptoms have resolved (at the discretion of the Clinical Investigator) at least 5 days prior to visit 1 (day -8).
• Weight loss or gain \>4.5 kg in the 3 months prior to visit 1 (day -8).
• Currently or planning to be on a weight loss regimen during the study.
• Antibiotic use within 1 month of visit 1 (day -8) and throughout the study period.

Sponsors & Collaborators

• Kemin Foods LC: lead

Study Sites (1)

Biofortis Innovation Services

Addison, Illinois, 60101, United States

Location

Study Officials

• Aditi Shah, MD

  Biofortis Innovation Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-Arm, Pilot Study

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: May 3, 2024
• Study Start: October 23, 2023
• Primary Completion: January 23, 2024
• Study Completion: January 24, 2024
• Last Updated: May 3, 2024

Record last verified: 2024-04

Locations

US (1)