Dietary Fiber (Inulin) for Gut Health and Immune Response
Trial Summary
What is the purpose of this trial?
The purpose of this study is to determine if adding dietary fiber, such as inulin, to a diet that does not have enough fiber would raise the levels of potentially beneficial bacteria, such as Bifidobacterium, in the gut. There is evidence to suggest that these microbes can affect gut health and immune response, including to vaccines. The investigators will examine how inulin in the diet (compared to the maltodextrin control) (1) causes changes in the composition and function of the gut microbes, (2) reduces gut inflammation and gut leakiness caused by the vaccine, (3) increases immune response to vaccination, and (4) changes the expression of important adhesion molecules on the surface of white blood cells. Intestinal and whole-body responses will be measured in all participants.
Will I have to stop taking my current medications?
The trial requires participants to stop taking certain medications, including anti-inflammatory drugs, antibiotics, anti-hypertensive drugs, anti-malaria drugs, drugs affecting the immune system, and biologics. If you are on any of these medications, you may need to stop them to participate in the study.
What data supports the effectiveness of the treatment Inulin, Fructo-oligosaccharides, Prebiotic fiber, Maltodextrin, and Ty21a Typhoid Fever Vaccine for gut health and immune response?
Research shows that inulin and fructo-oligosaccharides, as prebiotic fibers, can improve gut health by enhancing beneficial gut bacteria and reducing inflammation. Additionally, these fibers may boost immune function by positively affecting gut-associated immune tissues, which could be beneficial for overall health.12345
Is inulin safe for human consumption?
How is the treatment Inulin different from other treatments for gut health and immune response?
Inulin is unique because it is a prebiotic fiber that specifically promotes the growth of beneficial gut bacteria, which can improve gut health and immune function. Unlike other treatments, it is not digested by the body but is fermented in the colon, leading to beneficial changes in gut microbiota and systemic health effects.17101112
Research Team
Danielle Lemay, PhD
Principal Investigator
USDA, ARS, Western Human Nutrition Research Center
Ryan Snodgrass, PhD
Principal Investigator
USDA, ARS, Western Human Nutrition Research Center
Mary Kable, PhD
Principal Investigator
USDA, ARS, Western Human Nutrition Research Center
Bess Caswell, PhD
Principal Investigator
USDA, ARS, Western Human Nutrition Research Center
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Pre-Vaccine Treatment
Participants consume 12 grams/day of inulin or maltodextrin for 3 weeks before the administration of the Ty21a vaccine
Vaccine Administration and Treatment
Participants continue consuming inulin or maltodextrin during the 1 week of vaccine administration
Post-Vaccine Treatment
Participants continue consuming inulin or maltodextrin for 1 week after the vaccine administration
Follow-up
Participants are monitored for changes in immune response, gut microbiome, and other health markers
Treatment Details
Interventions
- Inulin
- Maltodextrin
- Ty21a Typhoid Fever Vaccine
Inulin is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
- Dietary supplement
- Prebiotic
- Dietary supplement
- Prebiotic
- Dietary supplement
- Prebiotic
- Dietary supplement
- Prebiotic
- Dietary supplement
- Prebiotic
- Dietary supplement
- Prebiotic
Find a Clinic Near You
Who Is Running the Clinical Trial?
USDA, Western Human Nutrition Research Center
Lead Sponsor
University of Minnesota
Collaborator