Inulin for Inflammation

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
USDA, ARS, Western Human Nutrition Research Center, Davis, CAInflammation+3 MoreInulin - DietarySupplement
Eligibility
18 - 50
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Inflammation
  • Typhoid
  • Vaccines
  • Leaky Gut Syndrome

Treatment Effectiveness

Study Objectives

6 Primary · 41 Secondary · Reporting Duration: 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

Day 26 and 58
Change in plasma antibody response to typhoid vaccination
Change in vaccine-specific serum antibody response to typhoid vaccination
Day 26
Typhoid Fever
Change in whole blood antibody response to typhoid vaccination
Day 26
Change in fecal antibody levels from typhoid vaccination
Change in vaccine-specific fecal IgA antibody levels from typhoid vaccination
Day 36
Change in T-cell response to typhoid vaccination
Day 36
Change in antibody response to typhoid vaccination
Day 7
Change in fecal myeloperoxidase
Change in fecal neopterin
Day 8
Body Weight Changes
Change in blood monocyte subsets
Change in plasma acute phase proteins
Change in plasma acute phase proteins and adhesion molecules
Change in plasma adhesion molecules
Change in plasma chemokines
Change in plasma cytokines as markers of systemic inflammation
Change in plasma myeloperoxidase
Change in plasma neopterin
Body Weight Changes
Day 8
Change in urinary D-mannitol
Change in urinary lactulose
Change in urinary lactulose and D-mannitol
Day 8
Change in markers of inflammation
Day 8
Change in marker of lipopolysaccharide (LPS) exposure
Change in plasma D-lactate
Change in plasma citrulline
Change in plasma diamine oxidase
Change in plasma intestinal fatty acid binding protein
Change in urinary sucralose
Day 58
Change in GI symptoms
Change in fecal SCFA
Change in fecal bile acids
Change in fecal calprotectin
Change in fecal calprotectin secretory immunoglobulin A (sIgA)
Change in fecal mRNA
Change in fecal metabolites
Change in fecal microbiome
Change in fecal microbiome function
Change in fecal microbiome identity
Change in fecal pH
Change in fecal secretory immunoglobulin A (sIgA)
Change in fecal secretory total immunoglobulin A (sIgA)
Change in stool consistency
Change in stool consistency and frequency
Day 58
Changes in dietary intake
Pre-study
Baseline dietary fiber intake

Trial Safety

Trial Design

2 Treatment Groups

Inulin and Ty21a Vaccine
1 of 2
Maltodextrin and Ty21a Vaccine
1 of 2

Experimental Treatment

Non-Treatment Group

60 Total Participants · 2 Treatment Groups

Primary Treatment: Inulin · Has Placebo Group · Phase < 1

Inulin and Ty21a VaccineExperimental Group · 2 Interventions: Inulin, Ty21a Typhoid Fever Vaccine · Intervention Types: DietarySupplement, Biological
Maltodextrin and Ty21a VaccinePlaceboComparator Group · 2 Interventions: Maltodextrin, Ty21a Typhoid Fever Vaccine · Intervention Types: DietarySupplement, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Inulin
2011
Completed Phase 4
~780

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 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

Who is running the clinical trial?

USDA, Western Human Nutrition Research CenterLead Sponsor
59 Previous Clinical Trials
20,958 Total Patients Enrolled
6 Trials studying Inflammation
552 Patients Enrolled for Inflammation
University of MinnesotaOTHER
1,272 Previous Clinical Trials
1,487,990 Total Patients Enrolled
16 Trials studying Inflammation
1,339 Patients Enrolled for Inflammation
Danielle Lemay, PhDPrincipal InvestigatorUSDA, ARS, Western Human Nutrition Research Center
2 Previous Clinical Trials
405 Total Patients Enrolled
1 Trials studying Inflammation
10 Patients Enrolled for Inflammation
Charles Stephensen, PhDPrincipal InvestigatorUSDA, ARS, Western Human Nutrition Research Center
1 Previous Clinical Trials
23 Total Patients Enrolled
Mary Kable, PhDPrincipal InvestigatorUSDA, ARS, Western Human Nutrition Research Center

Eligibility Criteria

Age 18 - 50 · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Your body mass index (BMI) falls between 18.5 and 30.9 kg/m2.
Men between the ages of 18-30 who drink less than 34 grams of alcohol per day.
Women between 18 and 30 years old who drink less than 28 grams of alcohol per day.
Women between the ages of 31 and 50 years old who consume less than 25 grams of alcohol per day are eligible.
Men between 31-50 years of age who consume less than 31 grams of alcohol per day.
References

Frequently Asked Questions

Is octogenarian age a permissible criterion for enrollment in this research study?

"In accordance with the requirements for enrollment, individuals must be between 18 and 50 years of age to qualify." - Anonymous Online Contributor

Unverified Answer

Are there any eligibility requirements for participation in this research trial?

"This research effort is seeking 60 individuals aged 18-50 with inflammation to participate. To be considered, applicants must satisfy the following parameters: Body Mass Index (BMI) of 18.5 - 30.9 kg/m2; females between ages 18 and 30 should consume no greater than 28 g/day while males in this age bracket cannot exceed 34 g/day; finally, for male and female participants over 31 years old, a maximum daily intake of 25g and 31g respectively is prescribed." - Anonymous Online Contributor

Unverified Answer

Are there any antecedent studies regarding the use of Inulin?

"Currently, there are 4 ongoing trials of Inulin in development, with none reaching Phase 3. Most trails for this medicine are located near Baltimore, Maryland but other centres across the USA have studies underway as well." - Anonymous Online Contributor

Unverified Answer

How many participants have been accepted into this research project?

"Affirmative. Clinicaltrial.gov data points to the fact that this trial is currently seeking participants, with an initial posting on September 27th 2022 and a final update being made November 29th of the same year. 60 people need to be enrolled at one location for successful completion." - Anonymous Online Contributor

Unverified Answer

Are there any available patient slots for this clinical research project?

"Data on clinicaltrials.gov indicates that this trial is presently recruiting potential participants, which first appeared on September 27th 2022 and was last revised November 29th 2022." - Anonymous Online Contributor

Unverified Answer

What results are researchers expecting from this clinical research?

"This clinical trial seeks to identify a change in antibody response to typhoid vaccination within Days 26, 37 and 39. Secondary objectives include assessing dietary fibre intake with a food frequency questionnaire, measuring acute phase reactants C-reactive protein (CRP) and serum amyloid A (SAA), as well as determining the relative abundance of colonic bacteria via polymerase chain reaction amplification and sequencing of 16s ribosomal RNA from stool samples collected 3 times per period." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.