WHNRC (Western Human Nutrition Research Center) Fiber Intervention Study

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

Inulin, a dietary fiber supplement, is known to increase gut levels of potentially beneficial bacteria, including Bifidobacterium that are indigenous to gut microbiomes. Our underlying hypothesis is that the commensal microbiome, including Bifidobacterium, in the proximal colon or distal ileum affects the environment of draining lymph nodes and can thus modulate immune responses, including to vaccines. In the current study, participants will consume 12 grams/day inulin or maltodextrin (control) for 3 weeks before the administration of the Ty21a typhoid fever vaccine, 1 week during the vaccine, and 1 week after the vaccine. Vaccine response will be measured by counting T cells and immunoglobulin G (IgG) or immunoglobulin A (IgA)-secreting plasma cells specific for Ty21a. Gut permeability will be measured at baseline, and before and after the vaccine administration. Systemic inflammation and immune activation will be measured by analyzing blood for markers of inflammation. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04543877
Study type	Interventional
Source	USDA, Western Human Nutrition Research Center
Contact	Ellen Bonnel, PhD
Phone	530-752-4184
Email	ellen.bonnel@usda.gov
Status	Recruiting
Phase	Early Phase 1
Start date	September 27, 2022
Completion date	September 30, 2025

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03995979` - Inflammation and Protein Restriction	N/A
Completed	`NCT03255187` - Effect of Dietary Supplemental Fish Oil in Alleviating Health Hazards Associated With Air Pollution	N/A
Completed	`NCT04507867` - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III	N/A
Completed	`NCT03577223` - Egg Effects on the Immunomodulatory Properties of HDL	N/A
Completed	`NCT04383561` - Relationship Between LRG and Periodontal Disease	N/A
Active, not recruiting	`NCT03622632` - Pilot Study to Measure Uric Acid in Traumatized Patients: Determinants and Prognostic Association
Completed	`NCT06216015` - Exercise Training and Kidney Transplantation	N/A
Completed	`NCT04856748` - Nomogram to Diagnose Prostatic Inflammation (PIN) in Men With Lower Urinary Tract Symptoms
Completed	`NCT05529693` - Efficacy of a Probiotic Strain on Level of Markers of Inflammation in an Elderly Population	N/A
Recruiting	`NCT05415397` - Treating Immuno-metabolic Depression With Anti-inflammatory Drugs	Phase 3
Recruiting	`NCT05670301` - Flemish Joint Effort for Biomarker pRofiling in Inflammatory Systemic Diseases	N/A
Recruiting	`NCT05775731` - Markers of Inflammation and of the Pro-thrombotic State in Hospital Shift and Day Workers
Completed	`NCT03859934` - Metabolic Effects of Melatonin Treatment	Phase 1
Completed	`NCT03429920` - Effect of Fermented Soy Based Product on Cardiometabolic Risk Factors	N/A
Completed	`NCT06065241` - Quantifiably Determine if the Botanical Formulation, LLP-01, Has a Significant Clinical Effect on Proteomic Inflammatory Biomarkers and Epigenetic Changes in Healthy, Older Individuals.	N/A
Completed	`NCT05864352` - The Role of Dietary Titanium Dioxide on the Human Gut Microbiome and Health
Completed	`NCT03318731` - Efficacy and Safety of Fenugreek Extract on Markers of Muscle Damage and Inflammation in Untrained Males	N/A
Not yet recruiting	`NCT06134076` - Comparing Effects of Fermented and Unfermented Pulses and Gut Microbiota	N/A
Not yet recruiting	`NCT06159543` - The Effects of Fresh Mango Consumption on Cardiometabolic Outcomes in Free-living Individuals With Prediabetes	N/A
Not yet recruiting	`NCT05910489` - Micro and Nanoplastics in Greenhouse Workers: Biomarkers of Exposure and Effect