HealthyNCT06397482
Effects of an Encapsulated Calcium Butyrate Dietary Supplement on Gut Health
A study testing Encapsulated Calcium Butyrate in people with Healthy and Gastrointestinal Discomfort, run by Kemin Foods LC at 1 site in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Gastrointestinal Discomfort
- What is being tested?
- Encapsulated Calcium Butyrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2023to 24 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ≥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.
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- 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.
Who cannot join
- 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).
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- 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.
- Use of steroids within 1 month of visit 1 (day -8) and throughout the study period.
- Regular use (i.e., >3 days/week) of anti-inflammatory medications (e.g., NSAIDs) within 1 month of visit 1 (day -8).
- Use of medications (over-the-counter or prescription) and/or dietary supplements, known to influence GI function, including but not limited to, pre-, post-, and probiotic supplements, fiber supplements, laxatives, enemas, suppositories, H2 blockers, proton pump inhibitors, antacids, anti-diarrheal agents, anti-depressants, and/or anti-spasmodic within 2 weeks of visit 1 (day -8) and throughout the study period. Standard multivitamin and mineral supplements are allowed.
- Underwent an endoscopy or colonoscopy preparation within 3 months prior to visit 1 (day -8).
- Exposure to any non-registered drug product within 1 month prior to visit 1 (day -8).
- Female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period. Subjects who are pregnant during the study will be discontinued.
- Recent history (within 12 months visit 1; day -8) of alcohol or substance abuse. Alcohol abuse is defined as >14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1½ oz distilled spirits).
- Self-report of blood donation totaling between 101 mL to 449 mL of blood within 1 month prior to screening or a blood donation of more than 450 mL within 56 days prior to baseline.
- Receipt or use of study products in another research study within 28 days prior to visit 2 (day 0) or longer if the previous study product is deemed by the Clinical Investigator to have lasting effects that might influence the eligibility criteria or outcomes of the current study.
- Has a condition the Clinical Investigator believes would interfere with his ability to provide informed consent, and comply with the study protocol, which might confound the interpretation of the study results, or put the subject at undue risk.
Trial locations and contacts
1 site in 1 country.
United States1 site
Biofortis Innovation Services
Addison, Illinois, 60101
About this study
Official title: A Single-Arm, Pilot Study to Assess the Effects of an Encapsulated Calcium Butyrate Dietary Supplement on Gut Health
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.
Read the detailed description
This will be a single-arm pilot study consisting of one screening visit (day -8) and four intervention visits (days 0, 1, 43, and 44).
On visit 1 (day -8), subjects will arrive at the clinic in a fasting state. After providing voluntary informed consent, subjects will undergo a medical history evaluation along with clinic visit procedures. Blood samples will be collected for safety analyses. Subjects will complete the Gastrointestinal Symptom Rating Scale (GSRS) and the Diet ID questionnaire. A Bowel Habits Diary (BHD) and stool collection kit will be dispensed to complete prior to visit 2.
On visit 2 (day 0), subjects will arrive at the clinic in a fasting state and undergo clinic visit procedures. Fecal samples and the BHD from visit 1 will be collected. Subjects will be administered the GSRS for determination of eligibility (at least mild symptoms of indigestion at visit 1 and 2). Enrolled participants will be administered the Digestion-associated Quality of Life Questionnaire (DQLQ). Blood samples will be collected for markers of intestinal permeability. Subjects will then complete an intestinal permeability test where they will ingest two sugar probes and be instructed to collect all urine over the following 24 h. A BHD and stool collection kit will be dispensed to complete prior to visit 4. Study product and a study product log will be dispensed.
On visit 3 (day 1), subjects will arrive at the clinic to return their urine collection containers.
On visit 4 (day 43), subjects will arrive at the clinic in a fasting state and undergo clinic visit procedures. Fecal samples and the BHD from visit 2 will be collected. Subjects will be administered the GSRS and DQLQ. Blood samples will be collected for safety analyses and markers of intestinal permeability. Subjects will then complete an intestinal permeability test as previously described. The study product log and unused study product will be collected.
On visit 5 (day 44), subjects will arrive at the clinic to return their urine collection containers.
Subjects will receive an email link for an electronic GSRS and DQLQ to be completed on days 8, 15, 22, 29, and 36.
- Conditions
- Healthy, Gastrointestinal Discomfort
- Being tested
- Encapsulated Calcium Butyrate
- Keywords
- Butyrate, Butyric Acid, Short-Chain Fatty Acid, Permeability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Encapsulated Calcium ButyrateDietary supplement
Contains at minimum 35% butyric acid
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Encapsulated Calcium Butyrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Indigestion Symptom Severity
Assessed by the Gastrointestinal Symptom Rating Scale (GSRS): minimum = 1 (no discomfort); maximum = 7 (very severe discomfort)
Measured: 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
Abdominal pain, reflux, diarrhea, and constipation assessed by the Gastrointestinal Symptom Rating Scale (GSRS): minimum = 1 (no discomfort); maximum = 7 (very severe discomfort)
Measured: Change from baseline (day 0) to end of each week (day 8, 15, 22, 29, 36, and 43)
Digestion-associated Quality of Life
Assessed by the Digestion-associated Quality of Life Questionnaire (DQLQ): minimum = 0% (never); maximum = 100% (always)
Measured: Change from baseline (day 0) to end of each week (day 8, 15, 22, 29, 36, and 43)
Ease of Stool Passage
Assessed by the Bowel Habits Diary (BHD): minimum = 1 (very easy); maximum = 5 (very difficult)
Measured: Change from baseline (day 0) to end of intervention (day 43)
Stool Consistency
Assessed by the Bristol Stool Scale (BSS): minimum = 1 (very solid); maximum = 7 (entirely liquid)
Measured: Change from baseline (day 0) to end of intervention (day 43)
Intestinal Permeability Marker 1
Assessed by lactulose/13C mannitol excretion
Measured: Change from baseline (day 0) to end of intervention (day 43)
Intestinal Permeability Marker 2
Assessed by blood lipopolysaccharide binding protein (LBP) concentrations
Measured: Change from baseline (day 0) to end of intervention (day 43)
Intestinal Permeability Marker 3
Assessed by blood zonulin concentrations
Measured: Change from baseline (day 0) to end of intervention (day 43)
Fecal Microbiome
Assessed by shotgun metagenomic sequencing
Measured: Change from baseline (day 0) to end of intervention (day 43)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start23 Oct 2023
- Primary completion23 Jan 2024
- Study completion24 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-Arm, Pilot Study
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kemin Foods LC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aditi Shah, MD, Principal investigator, Biofortis Innovation Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06397482
- Sponsor's protocol ID
- BIO-2314
- Status last verified
- Apr 2024
- First submitted
- 17 Apr 2024
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Pilot Study to Assess the Effects of an Encapsulated Calcium Butyrate Dietary Supplement on Gut Health
- ClinicalTrials.gov ID
- NCT06397482
- Acronym / sponsor ID
- BIO-2314
- Conditions
- Healthy, Gastrointestinal Discomfort
- Keywords
- Butyrate, Butyric Acid, Short-Chain Fatty Acid, Permeability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Kemin Foods LCIndustry (pharma, biotech, devices)
- Study start
- 23 Oct 2023 (actual)
- Primary completion
- 23 Jan 2024 (actual)
- Study completion
- 24 Jan 2024 (actual)
- First posted
- 3 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This will be a single-arm pilot study consisting of one screening visit (day -8) and four intervention visits (days 0, 1, 43, and 44).
On visit 1 (day -8), subjects will arrive at the clinic in a fasting state. After providing voluntary informed consent, subjects will undergo a medical history evaluation along with clinic visit procedures. Blood samples will be collected for safety analyses. Subjects will complete the Gastrointestinal Symptom Rating Scale (GSRS) and the Diet ID questionnaire. A Bowel Habits Diary (BHD) and stool collection kit will be dispensed to complete prior to visit 2.
On visit 2 (day 0), subjects will arrive at the clinic in a fasting state and undergo clinic visit procedures. Fecal samples and the BHD from visit 1 will be collected. Subjects will be administered the GSRS for determination of eligibility (at least mild symptoms of indigestion at visit 1 and 2). Enrolled participants will be administered the Digestion-associated Quality of Life Questionnaire (DQLQ). Blood samples will be collected for markers of intestinal permeability. Subjects will then complete an intestinal permeability test where they will ingest two sugar probes and be instructed to collect all urine over the following 24 h. A BHD and stool collection kit will be dispensed to complete prior to visit 4. Study product and a study product log will be dispensed.
On visit 3 (day 1), subjects will arrive at the clinic to return their urine collection containers.
On visit 4 (day 43), subjects will arrive at the clinic in a fasting state and undergo clinic visit procedures. Fecal samples and the BHD from visit 2 will be collected. Subjects will be administered the GSRS and DQLQ. Blood samples will be collected for safety analyses and markers of intestinal permeability. Subjects will then complete an intestinal permeability test as previously described. The study product log and unused study product will be collected.
On visit 5 (day 44), subjects will arrive at the clinic to return their urine collection containers.
Subjects will receive an email link for an electronic GSRS and DQLQ to be completed on days 8, 15, 22, 29, and 36.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-Arm, Pilot Study
| Arm | Type | Receives |
|---|---|---|
| Encapsulated Calcium Butyrate | Experimental | Dietary Supplement: Encapsulated Calcium ButyrateSubjects will be instructed to consume one 600 mg capsule daily, on an empty stomach, at least 30 minutes before their first meal. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- ≥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).
Key exclusion criteria (25 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Encapsulated Calcium ButyrateContains at minimum 35% butyric acid | Dietary supplement | Encapsulated Calcium Butyrate |
Primary outcome
Indigestion Symptom Severity
Time frame: Change from baseline (day 0) to end of each week (day 8, 15, 22, 29, 36, and 43)
Assessed by the Gastrointestinal Symptom Rating Scale (GSRS): minimum = 1 (no discomfort); maximum = 7 (very severe discomfort)
8 secondary outcomes
Other Gastrointestinal Symptom Severity
Time frame: Change from baseline (day 0) to end of each week (day 8, 15, 22, 29, 36, and 43)
Digestion-associated Quality of Life
Time frame: Change from baseline (day 0) to end of each week (day 8, 15, 22, 29, 36, and 43)
Ease of Stool Passage
Time frame: Change from baseline (day 0) to end of intervention (day 43)
Stool Consistency
Time frame: Change from baseline (day 0) to end of intervention (day 43)
Intestinal Permeability Marker 1
Time frame: Change from baseline (day 0) to end of intervention (day 43)
Intestinal Permeability Marker 2
Time frame: Change from baseline (day 0) to end of intervention (day 43)
Intestinal Permeability Marker 3
Time frame: Change from baseline (day 0) to end of intervention (day 43)
Fecal Microbiome
Time frame: Change from baseline (day 0) to end of intervention (day 43)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aditi Shah, MD principal investigator
Biofortis Innovation Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Encapsulated Calcium Butyrate in people with Healthy and Gastrointestinal Discomfort, run by Kemin Foods LC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Indigestion Symptom Severity (time frame: Change from baseline (day 0) to end of each week (day 8, 15, 22, 29, 36, and 43)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2024.