HealthyNCT05254340
Healthy Volunteer Short Chain Fatty Acid Study
A study testing Inulin in people with Healthy, run by Indiana University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the production of short chain fatty acids (fatty acids are part of your diet) in stool through the measurement of fecal inulin after a one-time ingestion of 10-gram dose of inulin among healthy adult volunteers. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Inulin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2021to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults ages 18-75 years with no prior history of GI disease or symptoms.
- Participants should be on a stable and consistent diet regimen and should not be following an extreme diet intervention such as gluten-free or a low fermentable oligo-, di-, monosaccharides, and polyols diet (FODMAP) diet at the time of study participation
Who cannot join
- History of microscopic colitis, inflammatory bowel disease, celiac disease, visceral cancer, chronic infectious disease, immunodeficiency, uncontrolled thyroid disease, history of liver disease or history of elevated aspartate transaminase/alanine transaminase > 2.0x the upper limit of normal
- Prior therapy of the abdomen or abdominal surgeries with the exception of appendectomy or cholecystectomy > 6 months prior to study initiation
- Ingestion of any prescription, over the counter, or herbal medications which can affect study interpretation within 6 months of study initiation for asymptomatic volunteers. Rescue therapy to facilitate stool collection will be permitted where needed.
- Any females who are pregnant or breast-feeding
- Antibiotic usage within 3 months prior to study participation
- Prebiotic or probiotic usage within the 2 weeks prior to study initiation
- Inulin usage within the 2 weeks prior to study initiation
- Use of tobacco products within the past 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Novel Approach to Measuring Intestinal Production of Short Chain Fatty Acids: A Proof-of-concept Healthy Volunteer Study
The purpose of this study is to evaluate the production of short chain fatty acids (fatty acids are part of your diet) in stool through the measurement of fecal inulin after a one-time ingestion of 10-gram dose of inulin among healthy adult volunteers.
Read the detailed description
The Study involves 2 visits and will include 3 types of subjects. Any healthy adult between the ages of 18 and 75 with no prior history of GI disease or symptoms is eligible to participate in the study.
Visit 1 (Day 1) - Screening Visit and Informed Consent At this Visit volunteers will do the following
- Volunteers will be asked to read and sign the informed consent after all questions about the study have been answered. This is a screening visit, and we may determine that the volunteers ineligible to continue to participate in the study.
- Volunteers will have medical history taken including demographics, symptoms and history of illness.
- Volunteers will be asked about the medications.
- A physical exam will be performed by the physician.
- Vital signs will be measured.
- Volunteers will be scheduled for study-days and will fill out a bowel disease questionnaire (BDQ).
- Volunteers will be provided instructions for collection, storage, and transportation of stool for your next visit.
- Volunteers will be provided a kit for stool collection, storage, and transportation.
- Volunteers will be provided a bowel pattern diary to record bowel symptoms over the course of the study.
- Volunteers will also be provided with 10-gram inulin powder supplement and will be required to consume the inulin before 9 am on Day 2.
Day 2 (at home):
- Day 2 reflects the first day of active study. Day 2 may occur anytime up to 30 days after Day 1. This will depend whether the volunteers need to stop any medications or on the day they are able to return for the final visit.
- Volunteers will have to consume the inulin supplement before 9 am on Day 2. The first 24-hour stool collection will begin starting at 7 am on Day 2 and will continue until 7 am on Day 3.
- All collected stool should be stored as per instructions provided on Day 1 (screening visit).
- Volunteers will be asked to record bowel symptoms using the bowel diary card and dietary intake data for four days from Day 2 through Day 5 by using diaries (diet information may be recorded using either the paper diaries that are provided or the web-based Automated Self-Administered Dietary Assessment Tool (https://epi.grants.cancer.gov/asa24/).
Day 3 to 4 (at home) - The second 24-hour stool collection will begin starting at 7 am on Day 3 and continue until 7 am Day 4. Volunteers will record the diet for Day 3 to 4 as "Day 3 Diet" and will record bowel symptoms using a Bowel Diary Card.
Day 4 to 5 (at home)- Volunteers will start third 24-hour stool collection at 7 am on Day 4 and continue until 7 am Day 5. The diet for Day 4 to 5 should be recorded as "Day 4 Diet." Volunteers will record the bowel symptoms using a Bowel Diary Card.
Day 5 to 6 (at home)- The fourth 24-hour stool collection begins at 7 am on Day 5 and continue until 7 am Day 6. Volunteers will record the diet for Day 5 to 6 as "Day 5 Diet" and will record bowel symptoms using a Bowel Diary Card.
Visit 2 (Day 6) - End of study: Volunteers will return the refrigerated stool specimens, bowel diaries and dietary intake diaries to the study team. Diaries may also be returned by mail, fax, or by electronic submission. For the diet diaries, volunteers will have the option to complete paper diaries or the Automated Self-Administered Dietary Assessment. Volunteers' participation in the study will end after this visit.
- Conditions
- Healthy
- Being tested
- Inulin
- Keywords
- bile acid, inulin, microbiota
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InulinDietary supplement
Inulin ingestion is not being used to diagnose, treat, or prevent irritable bowel syndrome. Inulin is being used to study an individual's ability to ferment dietary fiber.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Experimental | Adults ages 18-75 years with no prior history of gastrointestinal diseases or symptoms. Receives: Dietary Supplement: Inulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal Inulin
Fecal inulin content will be measured using short acid hydrolysis and high-performance liquid chromatography
Measured: 4 days
Total Fecal Short Chain Fatty Acids
Stool samples will be collected for measurement of measurement of short chain fatty acids (mmol/kg) by liquid chromatography-mass spectrometry
Measured: 4 days
Individual Fecal Short Chain Fatty Acids
Stool samples will be collected for measurement of measurement of short chain fatty acids (mmol/kg) by liquid chromatography-mass spectrometry
Measured: 4 days
Secondary outcomes (3)
Bowel Frequency
Stool characteristics will be measured using a 4 day bowel diary (stool frequency, stool form, ease of passage). Bowel frequency indicates the total number of bowel movements in 4 days.
Measured: 4 days
Dietary Intake
Baseline dietary intake will be measured using an automated self-administered dietary assessment tool
Measured: 24 hours
Bowel Symptoms
Stool characteristics will be measured using a 4 day bowel diary (stool frequency, stool form, ease of passage). Stool form is on a scale from 1 to 7, where 1=hard lumps, 2=lumps sausage, 3=cracked sausage, 4=normal, 5=soft lumps, 6=mushy, 7=watery, summarized on the level of bowel movements. Ease of passage is on a scale from 1 to 7, where 1=manual disimpaction, 2=enema needed, 3=straining needed, 4=normal, 5=urgent without pain, 6=urgent with pain, 7=incontinent, also summarized on the level of bowel movements.
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start1 Aug 2021
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Why it stopped: Study physician left the university
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huiping Xu, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05254340
- Sponsor's protocol ID
- 2010116953
- Other IDs
- K23DK122015
- Status last verified
- Sep 2024
- First submitted
- 7 Oct 2021
- Last updated
- 25 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- 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 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Approach to Measuring Intestinal Production of Short Chain Fatty Acids: A Proof-of-concept Healthy Volunteer Study
- ClinicalTrials.gov ID
- NCT05254340
- Acronym / sponsor ID
- 2010116953
- Conditions
- Healthy
- Keywords
- bile acid, inulin, microbiota
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study physician left the university
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 24 Feb 2022 (actual)
- Results
- Posted 25 Sep 2024
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 this study is to evaluate the production of short chain fatty acids (fatty acids are part of your diet) in stool through the measurement of fecal inulin after a one-time ingestion of 10-gram dose of inulin among healthy adult volunteers.
Detailed description
The Study involves 2 visits and will include 3 types of subjects. Any healthy adult between the ages of 18 and 75 with no prior history of GI disease or symptoms is eligible to participate in the study.
Visit 1 (Day 1) - Screening Visit and Informed Consent At this Visit volunteers will do the following
- Volunteers will be asked to read and sign the informed consent after all questions about the study have been answered. This is a screening visit, and we may determine that the volunteers ineligible to continue to participate in the study.
- Volunteers will have medical history taken including demographics, symptoms and history of illness.
- Volunteers will be asked about the medications.
- A physical exam will be performed by the physician.
- Vital signs will be measured.
- Volunteers will be scheduled for study-days and will fill out a bowel disease questionnaire (BDQ).
- Volunteers will be provided instructions for collection, storage, and transportation of stool for your next visit.
- Volunteers will be provided a kit for stool collection, storage, and transportation.
- Volunteers will be provided a bowel pattern diary to record bowel symptoms over the course of the study.
- Volunteers will also be provided with 10-gram inulin powder supplement and will be required to consume the inulin before 9 am on Day 2.
Day 2 (at home):
- Day 2 reflects the first day of active study. Day 2 may occur anytime up to 30 days after Day 1. This will depend whether the volunteers need to stop any medications or on the day they are able to return for the final visit.
- Volunteers will have to consume the inulin supplement before 9 am on Day 2. The first 24-hour stool collection will begin starting at 7 am on Day 2 and will continue until 7 am on Day 3.
- All collected stool should be stored as per instructions provided on Day 1 (screening visit).
- Volunteers will be asked to record bowel symptoms using the bowel diary card and dietary intake data for four days from Day 2 through Day 5 by using diaries (diet information may be recorded using either the paper diaries that are provided or the web-based Automated Self-Administered Dietary Assessment Tool (https://epi.grants.cancer.gov/asa24/).
Day 3 to 4 (at home) - The second 24-hour stool collection will begin starting at 7 am on Day 3 and continue until 7 am Day 4. Volunteers will record the diet for Day 3 to 4 as "Day 3 Diet" and will record bowel symptoms using a Bowel Diary Card.
Day 4 to 5 (at home)- Volunteers will start third 24-hour stool collection at 7 am on Day 4 and continue until 7 am Day 5. The diet for Day 4 to 5 should be recorded as "Day 4 Diet." Volunteers will record the bowel symptoms using a Bowel Diary Card.
Day 5 to 6 (at home)- The fourth 24-hour stool collection begins at 7 am on Day 5 and continue until 7 am Day 6. Volunteers will record the diet for Day 5 to 6 as "Day 5 Diet" and will record bowel symptoms using a Bowel Diary Card.
Visit 2 (Day 6) - End of study: Volunteers will return the refrigerated stool specimens, bowel diaries and dietary intake diaries to the study team. Diaries may also be returned by mail, fax, or by electronic submission. For the diet diaries, volunteers will have the option to complete paper diaries or the Automated Self-Administered Dietary Assessment. Volunteers' participation in the study will end after this visit.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | Experimental | Dietary Supplement: InulinAdults ages 18-75 years with no prior history of gastrointestinal diseases or symptoms. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy adults ages 18-75 years with no prior history of GI disease or symptoms.
- Participants should be on a stable and consistent diet regimen and should not be following an extreme diet intervention such as gluten-free or a low fermentable oligo-, di-, monosaccharides, and polyols diet (FODMAP) diet at the time of study participation
Key exclusion criteria (8 listed)
- History of microscopic colitis, inflammatory bowel disease, celiac disease, visceral cancer, chronic infectious disease, immunodeficiency, uncontrolled thyroid disease, history of liver disease or history of elevated aspartate transaminase/alanine transaminase > 2.0x the upper limit of normal
- Prior therapy of the abdomen or abdominal surgeries with the exception of appendectomy or cholecystectomy > 6 months prior to study initiation
- Ingestion of any prescription, over the counter, or herbal medications which can affect study interpretation within 6 months of study initiation for asymptomatic volunteers. Rescue therapy to facilitate stool collection will be permitted where needed.
- Any females who are pregnant or breast-feeding
- Antibiotic usage within 3 months prior to study participation
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 |
|---|---|---|
| InulinInulin ingestion is not being used to diagnose, treat, or prevent irritable bowel syndrome. Inulin is being used to study an individual's ability to ferment dietary fiber. | Dietary supplement | Healthy volunteers |
Primary outcome
Fecal Inulin
Time frame: 4 days
Fecal inulin content will be measured using short acid hydrolysis and high-performance liquid chromatography
Total Fecal Short Chain Fatty Acids
Time frame: 4 days
Stool samples will be collected for measurement of measurement of short chain fatty acids (mmol/kg) by liquid chromatography-mass spectrometry
Individual Fecal Short Chain Fatty Acids
Time frame: 4 days
Stool samples will be collected for measurement of measurement of short chain fatty acids (mmol/kg) by liquid chromatography-mass spectrometry
3 secondary outcomes
Bowel Frequency
Time frame: 4 days
Dietary Intake
Time frame: 24 hours
Bowel Symptoms
Time frame: 4 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
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 Inulin in people with Healthy, run by Indiana University 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 2 inclusion and 8 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: stopped early, as of the sponsor's last update on 25 Sep 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?
Yes. Results are posted in the registry (first posted 25 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Fecal Inulin (time frame: 4 days). The study lists 3 primary outcomes in all. 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 Sep 2024.