Effects of an Encapsulated Calcium Butyrate Dietary Supplement on Gut Health (NCT06397482) | Clinical Trial Compass
CompletedNot Applicable
Effects of an Encapsulated Calcium Butyrate Dietary Supplement on Gut Health
United States20 participantsStarted 2023-10-23
Plain-language 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.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion criteria
✓. ≥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).
Exclusion criteria
✕. 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.
What they're measuring
1
Indigestion Symptom Severity
Timeframe: Change from baseline (day 0) to end of each week (day 8, 15, 22, 29, 36, and 43)
✕. 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).