Intestinal PermeabilityNCT06262880
Dietary Supplementation on Gastrointestinal Barrier Function
A study testing plant derived phenolics and Microcrystaline cellulose (MCC) in people with Intestinal Permeability, run by Brightseed at 1 site in United States.
Trial summary
The purpose of the current study is to examine the effects of a dietary supplement containing plant derived phenolics at two different dose levels on parameters of gastrointestinal (GI) health in otherwise generally healthy adults with risk factors (high BMI and waist circumference) for increased GI permeability. Read more about this study
- Who is it for?
- Ages 30 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Intestinal Permeability
- What is being tested?
- plant derived phenolics and Microcrystaline cellulose (MCC)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2024to 6 Feb 2025
- 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 30 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, 30-69 years of age, inclusive at Visit 1 (Day -7).
- BMI of ≥29.0 to <40.0 kg/m2 at Visit 1 (Day -7).
- Waist circumference >102 cm for men and >88 cm for women.
- Non-user or former user (cessation ≥12 months) of tobacco or nicotine products (e.g., cigarette smoking, vaping, chewing tobacco) with no plans to begin use during the study period.
- Non-user of marijuana or hemp products within 6 months of Visit 1, with no plans to begin use during the study period. A washout of 7 days is required for topical products (e.g., lotions) and willing to refrain from use during the study.
- Willing to maintain physical activity and exercise patterns, body weight, and habitual diet throughout the trial.
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- Willing to refrain from exclusionary medications, supplements, and products throughout the study.
- No health conditions that would prevent him/her from fulfilling the study requirements as judged by the Clinical Investigator on the basis of medical history and routine laboratory test results.
- 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, intolerance, or allergy to any of the study products or their excipients.
- Abnormal chemistry or hematology laboratory test result(s) of clinical significance at Visit 1 (Day -7), 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 diagnosed GI condition that would potentially interfere with the evaluation of the study product (e.g., inflammatory bowel disease, irritable bowel syndrome, gastroparesis / malabsorption conditions, eosinophilic disorders of the GI tract, and clinically significant lactose or gluten intolerance or other food allergies).
- Recent (within 2 weeks of Visit 1; Day -7) 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 -7) of constipation (defined as <3 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 (e.g., Parkinson's disease, multiple sclerosis, etc.), psychiatric (including depression and/or anxiety disorders) or biliary disorders. Conditions which are well-controlled or resolved will be assessed by the Clinical Investigator on a case-by-case basis.
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- 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 -7). Stable use of hypertension medication is allowed [defined as no change in medication regimen within the 3 months prior to Visit 1 (Day -7)].
- Received a COVID-19 vaccine within 2 weeks of Visit 1 (Day -7) or expect to receive a COVID-19 vaccine during the study period.
- Received an influenza vaccine within 1 week of Visit 1 (Day -7). Influenza vaccine is allowed during the study but must not be received within 7 days prior to a study visit.
- Had a positive SARS-CoV2 test and experienced symptoms for >2 months (i.e., "long-haulers").
- Extreme dietary habits (e.g., ketogenic, very high protein, very high fiber, vegan/vegetarian) at the discretion of the Clinical Investigator.
- History or presence of cancer (including any malignant GI polyps) within 2 years of Visit 1 (Day -7), except for non-melanoma skin cancer.
- Major trauma or any other surgical event, including abdominal surgery which might influence GI function, within 3 months of Visit 1 (Day -7).
- Signs or symptoms of an active infection of clinical relevance* within 5 days of Visit 1 (Day -7). The visit may be rescheduled such that all signs and symptoms have resolved (at the discretion of the Clinical Investigator) at least 5 days prior to Visit 1 (Day -7).
- Antibiotic use within 1 month of Visit 1 (Day -7) 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 -7).
- Use of medications (over-the-counter or prescription) and/or dietary supplements known to influence GI function, including but not limited to, pre- and probiotic supplements as well as foods or beverages containing live probiotics (e.g., yogurt, kombucha), fiber supplements, laxatives, enemas, suppositories, histamine H2 receptor antagonists, proton pump inhibitors, antacids, anti-diarrheal agents, and/or anti-spasmodic within 2 weeks of Visit 1 (Day -7) and throughout the study period. Standard multivitamin and mineral supplements are allowed.
- Had a colonoscopy or endoscopy within 1 month prior to Visit 1 (Day -7).
- Exposure to any non-registered drug product within 4 weeks prior to Visit 1 (Day -7).
- 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.
- Female subjects who is unwilling to wear a tampon during the collection of the 24-h urine samples when these collections occur during the time of menstruation
- Recent history (within 12 months of screening; Visit 1; Day -7) 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).
- Has a condition the Clinical Investigator believes would interfere with his ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results, or put the subject at undue risk.
- If an infection occurs during the study period, test visits will be rescheduled until signs and symptoms have resolved (at the discretion of the Clinical Investigator) at least 5 days prior to the scheduled study visits.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Biofortis
Addison, Illinois, 60101
Chad Cook
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Investigate the Effects of a Dietary Supplement Containing N-trans-Caffeoyltyramine (NCT) and N-trans-Feruloyltyramine (NFT) on Gastrointestinal Barrier Function
The purpose of the current study is to examine the effects of a dietary supplement containing plant derived phenolics at two different dose levels on parameters of gastrointestinal (GI) health in otherwise generally healthy adults with risk factors (high BMI and waist circumference) for increased GI permeability. The primary hypothesis is that supplementation with plant derived phenolics will improve gut health compared to placebo.
- Conditions
- Intestinal Permeability
- Being tested
- plant derived phenolics, Microcrystaline cellulose (MCC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plant derived phenolicsDietary supplement
Dietary supplement containing plant derived phenolics
Microcrystaline cellulose (MCC)Other
Placebo treatment: Microcrystaline cellulose
| Study group | Role | What they receive |
|---|---|---|
| Placebo treatment | Placebo comparator | Placebo treatment (Microcrystaline cellulose): 1 capsule/d Receives: Other: Microcrystaline cellulose (MCC) |
| Active low dose of plant derived phenolics | Active comparator | Active low dose of plant derived phenolics via 1 capsule/d Receives: Dietary Supplement: plant derived phenolics |
| Active high dose of plant derived phenolics | Active comparator | Active high dose of plant derived phenolics via 1 capsule/d Receives: Dietary Supplement: plant derived phenolics |
What is being measured
The primary outcome is the main question the study is designed to answer.
0-2 h urine 13C Mannitol excretion
GI permeability will be assessed using a sugar probe (13C mannitol).
Measured: 0, and 42 days
Secondary outcomes (17)
2 to 8 h urine 13C Mannitol
GI permeability will be assessed using a sugar probe (13C mannitol).
Measured: 0, and 42 days
0 to 2 h urine LMR
GI permeability will be assessed using a two-sugar (lactulose and 13C mannitol) probe procedure.
Measured: 0, and 42 days
2 to 8 h urine LMR
GI permeability will be assessed using a two-sugar (lactulose and 13C mannitol) probe procedure. Two pooled urine samples (0-2 h and 2:01-8 h) will be collected over an 8 h period for subsequent analysis at Clinic.
Measured: 0, and 42 days
Blood Biomarkers
Soluble CD14
Measured: 0, and 42 days
Blood Biomarkers
LBP
Measured: 0, and 42 days
Blood Biomarkers
I-FABP
Measured: 0, and 42 days
Fecal Biomarkers
Secretory IgA
Measured: 0, and 42 days
Fecal Biomarkers
Calprotectin
Measured: 0, and 42 days
Inflammatory Biomarkers (Blood)
hsCRP
Measured: 0, and 42 days
Inflammatory Biomarkers (Blood)
IL-1β
Measured: 0, and 42 days
Inflammatory Biomarkers (Blood)
TNF-α
Measured: 0, and 42 days
Inflammatory Biomarkers (Blood)
IL-6
Measured: 0, and 42 days
7-day recall of gastrointestinal symptoms
Composite score of GITQ (sum of all 8 individual scores) Individual symptom GITQ score
Measured: 0, and 42 days
7-day recall of gastrointestinal symptoms
Individual symptom GITQ score
Measured: 0, and 42 days
Stool frequency
Bristol stool scale
Measured: 0, and 42 days
Stool consistency
Bristol stool scale
Measured: 0, and 42 days
Body Weight
Body Weight in kg.
Measured: 0, and 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start6 Feb 2024
- Primary completion20 Dec 2024 (estimated)
- Study completion6 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal PermeabilityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brightseed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06262880
- Sponsor's protocol ID
- BIO-2305
- Status last verified
- Mar 2024
- First submitted
- 31 Jan 2024
- Last updated
- 8 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Investigate the Effects of a Dietary Supplement Containing N-trans-Caffeoyltyramine (NCT) and N-trans-Feruloyltyramine (NFT) on Gastrointestinal Barrier Function
- ClinicalTrials.gov ID
- NCT06262880
- Acronym / sponsor ID
- BIO-2305
- Conditions
- Intestinal Permeability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- BrightseedIndustry (pharma, biotech, devices)
- Study start
- 6 Feb 2024 (actual)
- Primary completion
- 20 Dec 2024 (estimated)
- Study completion
- 6 Feb 2025 (estimated)
- First posted
- 16 Feb 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 purpose of the current study is to examine the effects of a dietary supplement containing plant derived phenolics at two different dose levels on parameters of gastrointestinal (GI) health in otherwise generally healthy adults with risk factors (high BMI and waist circumference) for increased GI permeability. The primary hypothesis is that supplementation with plant derived phenolics will improve gut health compared to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo treatment | Placebo comparator | Other: Microcrystaline cellulose (MCC)Placebo treatment (Microcrystaline cellulose): 1 capsule/d |
| Active low dose of plant derived phenolics | Active comparator | Dietary Supplement: plant derived phenolicsActive low dose of plant derived phenolics via 1 capsule/d |
| Active high dose of plant derived phenolics | Active comparator | Dietary Supplement: plant derived phenolicsActive high dose of plant derived phenolics via 1 capsule/d |
Who may qualify
- Ages
- 30 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female, 30-69 years of age, inclusive at Visit 1 (Day -7).
- BMI of ≥29.0 to <40.0 kg/m2 at Visit 1 (Day -7).
- Waist circumference >102 cm for men and >88 cm for women.
- Non-user or former user (cessation ≥12 months) of tobacco or nicotine products (e.g., cigarette smoking, vaping, chewing tobacco) with no plans to begin use during the study period.
- Non-user of marijuana or hemp products within 6 months of Visit 1, with no plans to begin use during the study period. A washout of 7 days is required for topical products (e.g., lotions) and willing to refrain from use during the study.
Key exclusion criteria (24 listed)
- Known sensitivity, intolerance, or allergy to any of the study products or their excipients.
- Abnormal chemistry or hematology laboratory test result(s) of clinical significance at Visit 1 (Day -7), 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 diagnosed GI condition that would potentially interfere with the evaluation of the study product (e.g., inflammatory bowel disease, irritable bowel syndrome, gastroparesis / malabsorption conditions, eosinophilic disorders of the GI tract, and clinically significant lactose or gluten intolerance or other food allergies).
- Recent (within 2 weeks of Visit 1; Day -7) 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 -7) of constipation (defined as <3 bowel movements per week).
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 |
|---|---|---|
| plant derived phenolicsDietary supplement containing plant derived phenolics | Dietary supplement | Active high dose of plant derived phenolics, Active low dose of plant derived phenolics |
| Microcrystaline cellulose (MCC)Placebo treatment: Microcrystaline cellulose | Other | Placebo treatment |
Primary outcome
0-2 h urine 13C Mannitol excretion
Time frame: 0, and 42 days
GI permeability will be assessed using a sugar probe (13C mannitol).
17 secondary outcomes
2 to 8 h urine 13C Mannitol
Time frame: 0, and 42 days
0 to 2 h urine LMR
Time frame: 0, and 42 days
2 to 8 h urine LMR
Time frame: 0, and 42 days
Blood Biomarkers
Time frame: 0, and 42 days
Blood Biomarkers
Time frame: 0, and 42 days
Blood Biomarkers
Time frame: 0, and 42 days
Fecal Biomarkers
Time frame: 0, and 42 days
Fecal Biomarkers
Time frame: 0, and 42 days
Inflammatory Biomarkers (Blood)
Time frame: 0, and 42 days
Inflammatory Biomarkers (Blood)
Time frame: 0, and 42 days
Inflammatory Biomarkers (Blood)
Time frame: 0, and 42 days
Inflammatory Biomarkers (Blood)
Time frame: 0, and 42 days
7-day recall of gastrointestinal symptoms
Time frame: 0, and 42 days
7-day recall of gastrointestinal symptoms
Time frame: 0, and 42 days
Stool frequency
Time frame: 0, and 42 days
Stool consistency
Time frame: 0, and 42 days
Body Weight
Time frame: 0, and 42 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing plant derived phenolics and Microcrystaline cellulose (MCC) in people with Intestinal Permeability, run by Brightseed 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 9 inclusion and 24 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: status not confirmed, as of the sponsor's last update on 8 Mar 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Doug Bolster, PhD ((720)527-4131, doug.bolster@brightseedbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
0-2 h urine 13C Mannitol excretion (time frame: 0, and 42 days). 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 8 Mar 2024.