60 Participants Needed

Dietary Fiber (Inulin) for Gut Health and Immune Response

EB
YA
Overseen ByYuriko Adkins, PhD
Age: 18 - 65
Sex: Any
Trial Phase: Phase < 1
Sponsor: USDA, Western Human Nutrition Research Center
Approved in 6 JurisdictionsThis treatment is already approved in other countries

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?

Inulin is generally considered safe and well-tolerated in humans up to 20 grams per day, although some people may experience mild gastrointestinal symptoms. It is a type of dietary fiber found in many foods and is used to improve gut health and immune response.16789

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

DL

Danielle Lemay, PhD

Principal Investigator

USDA, ARS, Western Human Nutrition Research Center

RS

Ryan Snodgrass, PhD

Principal Investigator

USDA, ARS, Western Human Nutrition Research Center

MK

Mary Kable, PhD

Principal Investigator

USDA, ARS, Western Human Nutrition Research Center

BC

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

I am a male between 18 and 30 years old.
I am a woman aged 31-50 and drink less than 25g of alcohol daily.
I am a man aged 31-50 and consume less than 31 grams of alcohol daily.
See 3 more

Exclusion Criteria

I am taking medication for high blood pressure.
Regular blood or blood product donation and refusal to suspend donation
I have not had severe diarrhea or constant vomiting in the last 2 weeks.
See 36 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Vaccine Treatment

Participants consume 12 grams/day of inulin or maltodextrin for 3 weeks before the administration of the Ty21a vaccine

3 weeks

Vaccine Administration and Treatment

Participants continue consuming inulin or maltodextrin during the 1 week of vaccine administration

1 week

Post-Vaccine Treatment

Participants continue consuming inulin or maltodextrin for 1 week after the vaccine administration

1 week

Follow-up

Participants are monitored for changes in immune response, gut microbiome, and other health markers

4 weeks

Treatment Details

Interventions

  • Inulin
  • Maltodextrin
  • Ty21a Typhoid Fever Vaccine
Trial OverviewThe 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.
Participant Groups
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.

Inulin is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

🇪🇺
Approved in European Union as Inulin for:
  • Dietary supplement
  • Prebiotic
🇺🇸
Approved in United States as Inulin for:
  • Dietary supplement
  • Prebiotic
🇨🇦
Approved in Canada as Inulin for:
  • Dietary supplement
  • Prebiotic
🇯🇵
Approved in Japan as Inulin for:
  • Dietary supplement
  • Prebiotic
🇨🇳
Approved in China as Inulin for:
  • Dietary supplement
  • Prebiotic
🇨🇭
Approved in Switzerland as Inulin for:
  • Dietary supplement
  • Prebiotic

Find a Clinic Near You

Who Is Running the Clinical Trial?

USDA, Western Human Nutrition Research Center

Lead Sponsor

Trials
64
Recruited
19,100+

University of Minnesota

Collaborator

Trials
1,459
Recruited
1,623,000+

Findings from Research

In a 3-month randomized, placebo-controlled trial involving 24 obese patients, the intake of inulin-type fructans (ITF) significantly increased levels of beneficial gut bacteria, specifically Bifidobacterium, and reduced fecal calprotectin, a marker of gut inflammation.
The study suggests that ITF may help improve gut health in obese individuals by decreasing inflammation and potentially influencing gut microbiota-derived metabolites, although it did not significantly change short-chain fatty acid levels.
Prebiotic dietary fibre intervention improves fecal markers related to inflammation in obese patients: results from the Food4Gut randomized placebo-controlled trial.Neyrinck, AM., Rodriguez, J., Zhang, Z., et al.[2022]
Both arabinoxylo-oligosaccharides (AXOS) and inulin significantly lowered the pH in gut fermentations, resulting in increased production of beneficial short-chain fatty acids like acetate, propionate, and butyrate, which are important for gut health.
The study found that AXOS and inulin differentially modulated gut microbiota composition and immune responses in a donor-specific manner, enhancing gut barrier function and immune markers such as IL-10 and IL-6.
Arabinoxylo-Oligosaccharides and Inulin Impact Inter-Individual Variation on Microbial Metabolism and Composition, Which Immunomodulates Human Cells.Van den Abbeele, P., Taminiau, B., Pinheiro, I., et al.[2018]
Fermentation of various dietary fibers, particularly oat β-glucan, significantly enhances gut barrier integrity and mucus production, suggesting these fibers can improve gut health.
In models of compromised gut barriers, oat β-glucan and maltodextrin fermentation products were particularly effective in restoring gut integrity, highlighting their potential as therapeutic agents for gut-related issues.
The effects of fermentation products of prebiotic fibres on gut barrier and immune functions in vitro.Pham, VT., Seifert, N., Richard, N., et al.[2020]

References

Prebiotic dietary fibre intervention improves fecal markers related to inflammation in obese patients: results from the Food4Gut randomized placebo-controlled trial. [2022]
Arabinoxylo-Oligosaccharides and Inulin Impact Inter-Individual Variation on Microbial Metabolism and Composition, Which Immunomodulates Human Cells. [2018]
The effects of fermentation products of prebiotic fibres on gut barrier and immune functions in vitro. [2020]
Enhanced vaccination effect against influenza by prebiotics in elderly patients receiving enteral nutrition. [2022]
Inulin and oligofructose: review of experimental data on immune modulation. [2023]
Insight into the prebiotic concept: lessons from an exploratory, double blind intervention study with inulin-type fructans in obese women. [2022]
Significance of Inulin Fructans in the Human Diet. [2021]
The bifidogenic effect of inulin and oligofructose and its consequences for gut health. [2023]
Inulin fructans in diet: Role in gut homeostasis, immunity, health outcomes and potential therapeutics. [2022]
Chain length-dependent effects of inulin-type fructan dietary fiber on human systemic immune responses against hepatitis-B. [2023]
11.United Statespubmed.ncbi.nlm.nih.gov
The Prebiotic Potential of Inulin-Type Fructans: A Systematic Review. [2023]
Introducing inulin-type fructans. [2021]