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Dietary Supplement
Inulin Digestion in Healthy Subjects
N/A
Waitlist Available
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Healthy adults ages 18-75 years with no prior history of GI disease or symptoms
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours
Awards & highlights
Study Summary
This trial will test how well the body breaks down inulin, a type of dietary fiber, into short chain fatty acids.
Who is the study for?
This study is for healthy adults aged 18-75 with no gastrointestinal diseases or symptoms, not on extreme diets like gluten-free or low FODMAP. They shouldn't have a history of certain chronic diseases, recent medication that affects the study, be pregnant/breastfeeding, use tobacco, or have taken prebiotics/probiotics recently.Check my eligibility
What is being tested?
The trial tests how a one-time dose of inulin (a dietary component) affects the production of short chain fatty acids in stool among healthy volunteers. It's to understand how this substance is processed by the body after ingestion.See study design
What are the potential side effects?
Since inulin is generally considered safe and participants are healthy volunteers, significant side effects are not expected. However, some individuals may experience mild digestive discomfort such as bloating or gas.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 75 years old and have never had GI diseases or symptoms.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Fecal inulin
Individual fecal short chain fatty acids
Total fecal short chain fatty acids
Secondary outcome measures
Bowel Symptoms
Dietary Intake
Trial Design
1Treatment groups
Experimental Treatment
Group I: Healthy volunteersExperimental Treatment1 Intervention
Adults ages 18-75 years with no prior history of gastrointestinal diseases or symptoms.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Inulin
2011
Completed Phase 4
~780
Find a Location
Who is running the clinical trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,359 Previous Clinical Trials
4,315,445 Total Patients Enrolled
Indiana UniversityLead Sponsor
980 Previous Clinical Trials
983,251 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had abdominal surgery, but it was either an appendectomy or cholecystectomy over 6 months ago.I have had cancer in my internal organs.I have a history of liver disease or high liver enzymes.I have been diagnosed with celiac disease.I have a history of thyroid disease that is not well-controlled.I am between 18 and 75 years old and have never had GI diseases or symptoms.I have a long-term infectious disease.I have been diagnosed with microscopic colitis.I have not used inulin in the last 2 weeks.I am not pregnant or breastfeeding.I have a history of inflammatory bowel disease.I haven't taken any medication that could affect the study in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Healthy volunteers
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are any new participants being accepted into this clinical investigation?
"Affirmative, the clinicaltrials.gov website is indicative of this trial's active recruitment phase; it was first published on August 1st 2021 and last updated February 15th 2022. The research seeks to recruit 50 individuals from a single study site."
Answered by AI
Are any geriatric patients being included in this clinical investigation?
"Based on the inclusion criteria, individuals aged 18 to 75 are suitable for enrollment in this trial. Additionally, 50 clinical trials cater exclusively to people under 18 and 372 studies accommodate those over 65 years of age."
Answered by AI
What are the eligibility criteria for participation in this trial?
"Candidates that hope to join this clinical trial should be in good health and aged between 18-75. Approximately 50 participants are required for the study's completion."
Answered by AI
How many participants are being recruited to join the research endeavor?
"Affirmative, the data posted on clinicaltrials.gov suggests this medical trial is presently recruiting participants. The study was first listed on August 1st 2021 and most recently edited on February 15th 2022; as of now they are searching for 50 subjects at a single site."
Answered by AI
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