HealthyBGNCT05601635
ButyraGen™, Short Chain Fatty Acids and Gut Microbiome
A study testing ButyraGen™ in people with Healthy, run by Clinical Nutrition Research Center, Illinois Institute of Technology at 1 site in United States.
Trial summary
This study is being conducted to demonstrate short chain fatty acid (SCFA), specifically butyrate, generation in stool, blood and urine in response to oral intake of ButyraGen™. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ButyraGen™
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Oct 2022to 11 Jan 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is a male or female, 18 years of age, inclusive.
- Subject has a BMI of 20.0-30.0 kg/m2, inclusive and a weight ≥ 110 lb. at the screening visit.
- Subject is willing to maintain his/her usual physical activity pattern throughout the study period.
- Subject is willing to follow study instructions, including compliance with certain dietary restrictions, consumption of study products, and study visit schedule.
- Subject is judged to be in good health on the basis of the medical history.
- Subject is willing to abstain from alcohol consumption for 24 hours prior to the study visit.
- Subject is willing to maintain a stable dose of current medications not interfering with study outcomes, including birth control, throughout the study duration.
- Subject understands the study procedures and signs forms documenting informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator/s and is willing to complete study procedures.
Who cannot join
- Subject has fasting finger prick glucose >125 mg/dL.
- Subject has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg) at the screening visit.
- Subject has had major trauma or a surgical event within 2 months of study visit 1.
- Subject has had a weight change ≥4.5 kg within 2 months of visit, taking weight loss drugs, or has had bariatric surgery or other weight reduction surgery (ie. liposuction, laser fat removal, etc)
- Subject has a history or presence of clinically important endocrine, cardiovascular (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), pulmonary, biliary, or gastrointestinal disorders that, in the opinion of the Investigator, could interfere with the interpretation of the study results.
- Subject has a history or presence of cancer in the prior 2 years, except for non-melanoma skin cancer.
Show all 19Show fewer
- Subject has a history of extreme dietary habits, as judged by the Investigator (e.g., Atkins diet, etc.).
- Subject has a history of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating) diagnosed by a health professional.
- Subject has a known intolerance or sensitivity to any ingredients in the study products.
- Subject has used medications known to influence carbohydrate and lipid metabolism, including, but not limited to adrenergic blockers, diuretics, hypoglycemic medications, and systemic corticosteroids 2 weeks prior to visit 0 and throughout the study or other medication(s) that may interfere with results of study.
- Subject taking fiber supplements.
- Subject taking systemic steroids, extreme alcohol use, or drug user.
- Subject has a vein access score of less than 7
- Subject is a female who is pregnant, planning to be pregnant during the study period or lactating.
- Subject is a current smoker. Past smoker abstinence for less than 1 years.
- Subject has participated in any clinical trial within 30 days prior to enrollment unless otherwise approved by the study Investigator.
- Subjects who are vegan or vegetarian
- Subjects who work overnight shift (e.g 3rd shift)
- Subject who donated blood within the last 3 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Nutrition Research Center
Chicago, Illinois, 60616
About this study
Official title: A Pilot Study to Demonstrate Butyrate Generation in Stool in Response to Oral Administration of ButyraGen™ in Healthy Human Subjects
This study is being conducted to demonstrate short chain fatty acid (SCFA), specifically butyrate, generation in stool, blood and urine in response to oral intake of ButyraGen™.
Read the detailed description
The proposed study will be conducted in humans according to Good Clinical Practice (GCP) guidelines. All subjects will review and sign an Informed Consent Form approved by the Illinois Institute of Technology's Institutional Review Boards (IRB) prior to screening.
This is a single-center study will follow a randomized, single-blinded parallel design with two doses. It features a 1-week intake of control followed by 3 weeks of either low dose (200 mg ButyraGen, containing 100 mg tributyrin) or high dose (400 mg, containing 200 mg tributyrin) of intervention to evaluate the effects of the active ingredient tributyrin after chronic intake in generally healthy individuals.
A planned sample size of 24 will be enrolled in the study. This study will require one initial screening visit, a pre-study visit, and 6 study day visits. The study will last about 5 weeks to complete all study procedures for each participant.
The initial screening visit will provide subjects with their site-specific, IRB approved informed consent document prior to the start of any study-related procedures. Subject eligibility will be determined through anthropometric measurements, vital signs, fasting blood glucose test (finger prick), fasting blood sample screened for complete blood count (CBC) and basic metabolic panel (BMP), and surveys related to general eating, health, mood and exercise habits.
Subjects will be randomized to 1 of 2 interventions: low dose (100 mg - tributyrin) or high does (200 mg - tributyrin). All subjects will receive 1 week of control (0 mg - tributyrin), then same treatment (low or high dose) for the remaining duration of the study. Treatment codes will be maintained by the principal investigator. Two of the 6 study days (first and last) will last ~7 hours and include a lactulose-mannitol test. In general, this test will ask you to collect your 1st urine of the day, drink a sugary beverage and collect all urine for the next 6 hours after the drink. The other 4 study days will last ~2 hours. Subjects will be required to remain at the Clinical Nutrition Research Center for the duration of the visit. Fasting blood samples will be collected via a butterfly needle by a certified phlebotomist.
- Conditions
- Healthy
- Being tested
- ButyraGen™
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ButyraGen™Dietary supplement
ButyraGen™ contains tributyrin as the primary active as well as Sunfiber®, a partially hydrolyzed guar fiber, and acacia fiber.
| Study group | Role | What they receive |
|---|---|---|
| High dose | Active comparator | Dietary supplement containing 200 mg of active ingredient tributyrin Receives: Dietary Supplement: ButyraGen™ |
| Low dose | Active comparator | Dietary supplement containing 100 mg of active ingredient tributyrin Receives: Dietary Supplement: ButyraGen™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
SCFAs in stool, blood and urine samples
Outcome measure will be quantified via GC-FID
Measured: Baseline to 4 weeks
Secondary outcomes (2)
Lactulose-mannitol test for leaky gut
Outcome measure will be analyzed by Genova Diagnostics
Measured: Baseline to 4 weeks
Questionnaire for study product tolerability
Yes or no question for experiences felt during study. If yes, rated based on how often - "much less than usual" to "much more than usual".
Measured: Baseline to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2022
- Study start19 Oct 2022
- Primary completion11 Jan 2023
- Study completion11 Jan 2023
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.
- More trials run by Clinical Nutrition Research Center, Illinois Institute of TechnologyThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05601635
- Sponsor's protocol ID
- IRB-2023-25
- Acronym
- BG
- Status last verified
- May 2023
- First submitted
- 24 Oct 2022
- Last updated
- 25 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Demonstrate Butyrate Generation in Stool in Response to Oral Administration of ButyraGen™ in Healthy Human Subjects
- ClinicalTrials.gov ID
- NCT05601635
- Acronym / sponsor ID
- BG / IRB-2023-25
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Clinical Nutrition Research Center, Illinois Institute of TechnologyIndustry (pharma, biotech, devices)
- Study start
- 19 Oct 2022 (actual)
- Primary completion
- 11 Jan 2023 (actual)
- Study completion
- 11 Jan 2023 (actual)
- First posted
- 1 Nov 2022 (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.
This study is being conducted to demonstrate short chain fatty acid (SCFA), specifically butyrate, generation in stool, blood and urine in response to oral intake of ButyraGen™.
Detailed description
The proposed study will be conducted in humans according to Good Clinical Practice (GCP) guidelines. All subjects will review and sign an Informed Consent Form approved by the Illinois Institute of Technology's Institutional Review Boards (IRB) prior to screening.
This is a single-center study will follow a randomized, single-blinded parallel design with two doses. It features a 1-week intake of control followed by 3 weeks of either low dose (200 mg ButyraGen, containing 100 mg tributyrin) or high dose (400 mg, containing 200 mg tributyrin) of intervention to evaluate the effects of the active ingredient tributyrin after chronic intake in generally healthy individuals.
A planned sample size of 24 will be enrolled in the study. This study will require one initial screening visit, a pre-study visit, and 6 study day visits. The study will last about 5 weeks to complete all study procedures for each participant.
The initial screening visit will provide subjects with their site-specific, IRB approved informed consent document prior to the start of any study-related procedures. Subject eligibility will be determined through anthropometric measurements, vital signs, fasting blood glucose test (finger prick), fasting blood sample screened for complete blood count (CBC) and basic metabolic panel (BMP), and surveys related to general eating, health, mood and exercise habits.
Subjects will be randomized to 1 of 2 interventions: low dose (100 mg - tributyrin) or high does (200 mg - tributyrin). All subjects will receive 1 week of control (0 mg - tributyrin), then same treatment (low or high dose) for the remaining duration of the study. Treatment codes will be maintained by the principal investigator. Two of the 6 study days (first and last) will last ~7 hours and include a lactulose-mannitol test. In general, this test will ask you to collect your 1st urine of the day, drink a sugary beverage and collect all urine for the next 6 hours after the drink. The other 4 study days will last ~2 hours. Subjects will be required to remain at the Clinical Nutrition Research Center for the duration of the visit. Fasting blood samples will be collected via a butterfly needle by a certified phlebotomist.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High dose | Active comparator | Dietary Supplement: ButyraGen™Dietary supplement containing 200 mg of active ingredient tributyrin |
| Low dose | Active comparator | Dietary Supplement: ButyraGen™Dietary supplement containing 100 mg of active ingredient tributyrin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject is a male or female, 18 years of age, inclusive.
- Subject has a BMI of 20.0-30.0 kg/m2, inclusive and a weight ≥ 110 lb. at the screening visit.
- Subject is willing to maintain his/her usual physical activity pattern throughout the study period.
- Subject is willing to follow study instructions, including compliance with certain dietary restrictions, consumption of study products, and study visit schedule.
- Subject is judged to be in good health on the basis of the medical history.
Key exclusion criteria (19 listed)
- Subject has fasting finger prick glucose >125 mg/dL.
- Subject has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg) at the screening visit.
- Subject has had major trauma or a surgical event within 2 months of study visit 1.
- Subject has had a weight change ≥4.5 kg within 2 months of visit, taking weight loss drugs, or has had bariatric surgery or other weight reduction surgery (ie. liposuction, laser fat removal, etc)
- Subject has a history or presence of clinically important endocrine, cardiovascular (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), pulmonary, biliary, or gastrointestinal disorders that, in the opinion of the Investigator, could interfere with the interpretation of the study results.
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 |
|---|---|---|
| ButyraGen™ButyraGen™ contains tributyrin as the primary active as well as Sunfiber®, a partially hydrolyzed guar fiber, and acacia fiber. | Dietary supplement | High dose, Low dose |
Primary outcome
SCFAs in stool, blood and urine samples
Time frame: Baseline to 4 weeks
Outcome measure will be quantified via GC-FID
2 secondary outcomes
Lactulose-mannitol test for leaky gut
Time frame: Baseline to 4 weeks
Questionnaire for study product tolerability
Time frame: Baseline to 4 weeks
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 25 May 2023.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ButyraGen™ in people with Healthy, run by Clinical Nutrition Research Center, Illinois Institute of Technology 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 8 inclusion and 19 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 25 May 2023. 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?
SCFAs in stool, blood and urine samples (time frame: Baseline to 4 weeks). 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 25 May 2023.