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Dietary Supplement
Dietary Fiber (Inulin) for Gut Health and Immune Response
Phase < 1
Recruiting
Led By Mary Kable, PhD
Research Sponsored by USDA, Western Human Nutrition Research Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Males 18 - 30 years old, less than 34 g/day
Females 31 - 50 years old, less than 25 g/day
Timeline
Screening 3 weeks
Treatment Varies
Follow Up period 1: days 1-7; period 2: days 16-25; period 3: days 26-36; period 4: days 37-43; period 5: days 58-65
Awards & highlights
Study Summary
This trial will test whether adding dietary fiber, in the form of inulin, to a diet lacking in fiber will raise levels of potentially beneficial gut bacteria, such as Bifidobacterium. The investigators will examine how inulin affects gut health and immune response, including to vaccines.
Who is the study for?
This trial is for healthy men and women aged 18-50 with a BMI of 18.5-30.9 who don't eat enough fiber, defined as less than daily recommended amounts based on age and gender. Participants should not have used certain medications recently, including antibiotics or anti-malaria drugs, have no history of typhoid fever or GI surgery, are not pregnant or lactating, do not have chronic illnesses like diabetes or heart disease, and are willing to avoid some supplements during the study.Check my eligibility
What is being tested?
The study tests if adding inulin (a type of dietary fiber) instead of maltodextrin (control) to participants' diets can improve gut health by increasing beneficial bacteria levels and enhancing immune response to the Ty21a typhoid vaccine. It will measure changes in gut microbes, inflammation reduction, vaccine response enhancement, and white blood cell adhesion molecule expression.See study design
What are the potential side effects?
Potential side effects may include digestive discomfort such as bloating or gas due to increased fiber intake with inulin. The Ty21a typhoid vaccine could cause mild reactions like soreness at the injection site or low-grade fever.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a male between 18 and 30 years old.
Select...
I am a woman aged 31-50 and drink less than 25g of alcohol daily.
Select...
I am a man aged 31-50 and consume less than 31 grams of alcohol daily.
Select...
I am a woman aged 18-30 and drink less than 28 grams of alcohol daily.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ period 1: days 1-7; period 2: days 16-25; period 3: days 26-36; period 4: days 37-43; period 5: days 58-65
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~period 1: days 1-7; period 2: days 16-25; period 3: days 26-36; period 4: days 37-43; period 5: days 58-65
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Typhoid Fever
Secondary outcome measures
Change in GI symptoms
Body Weight Changes
Change in blood monocyte subsets
+14 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Inulin and Ty21a VaccineExperimental Treatment2 Interventions
Participants will consume 12 grams/day of inulin for 3 weeks before the administration of the Ty21a vaccine, 1 week during the vaccine, and 1 week after the vaccine for a total of 5 weeks.
Group II: Maltodextrin and Ty21a VaccinePlacebo Group2 Interventions
Participants will consume 12 grams/day of maltodextrin (control) for 3 weeks before the administration of the Ty21a vaccine, 1 week during the vaccine, and 1 week after the vaccine for a total of 5 weeks.
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?
University of MinnesotaOTHER
1,389 Previous Clinical Trials
1,553,027 Total Patients Enrolled
17 Trials studying Inflammation
1,238 Patients Enrolled for Inflammation
USDA, Western Human Nutrition Research CenterLead Sponsor
62 Previous Clinical Trials
21,047 Total Patients Enrolled
7 Trials studying Inflammation
582 Patients Enrolled for Inflammation
Mary Kable, PhDPrincipal InvestigatorUSDA, ARS, Western Human Nutrition Research Center
1 Previous Clinical Trials
80 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a male between 18 and 30 years old.I am taking medication for high blood pressure.I have not had severe diarrhea or constant vomiting in the last 2 weeks.I have not had a fever in the last 2 weeks.You have a history of a weak immune system or an autoimmune disease.I haven't received any vaccines in the two weeks before getting the Ty21a vaccine.You are allergic to the oral typhoid vaccine.I have a chronic illness such as diabetes, heart disease, or liver disease.You have a higher chance of experiencing problems if you receive a live, bacterial vaccine.I have a history of stomach or bowel problems like Crohn's, IBS, or ulcers.I have fewer than 3 bowel movements weekly.I am a woman aged 31-50 and drink less than 25g of alcohol daily.I have not used immune system affecting drugs like cortisone for 2 weeks or more.You cannot continue taking probiotics, prebiotics, or certain supplements and foods during the study.I have asthma and take medication for it every day.I am currently taking or have recently taken anti-malaria medication.I do not have a vein in my arm suitable for drawing blood.I have had surgery on my digestive system.I agree to use birth control before, during, and after the vaccine period.I was hospitalized within the last 3 months.I have received the typhoid vaccine in the last 5 years.I have lived in a typhoid-endemic area for over 10 years.I am currently receiving cancer treatment with radiation or medication.I am a man aged 31-50 and consume less than 31 grams of alcohol daily.I have had typhoid fever in the past.Your body weight is within a healthy range based on your height.I haven't taken sulfonamides or antibiotics in the last 3 months.I have been using a biologic medication for at least 2 weeks.I have been diagnosed with cancer.I have not had surgery in the last 3 months.I cannot lift 30 pounds even with help.I have HIV/AIDS or another immune system condition.I am a woman aged 18-30 and drink less than 28 grams of alcohol daily.I'm sorry, but the criterion you provided is incomplete. Could you please provide the full description of the criterion?I regularly take anti-inflammatory medications like aspirin or NSAIDs.I am not willing to undergo blood draws or provide stool samples.You have been eating foods with added inulin (a type of fiber) every day for the past month.You are allergic to the ingredients used in the vaccine, such as thimerosal and enteric-coated capsules.
Research Study Groups:
This trial has the following groups:- Group 1: Inulin and Ty21a Vaccine
- Group 2: Maltodextrin and Ty21a Vaccine
Awards:
This trial has 0 awards, including: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.
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