WHNRC (Western Human Nutrition Research Center) Fiber Intervention Study

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.

Conditions

• Inflammation
• Vaccine
• Intestinal Permeability
• Typhoid Fever

Interventions

DIETARY_SUPPLEMENT

Inulin

Consume 12 grams/day of inulin for 5 weeks (Day 9 - 43).

DIETARY_SUPPLEMENT

Maltodextrin

Consume 12 grams/day of maltodextrin for 5 weeks (Day 9 - 43).

BIOLOGICAL

Ty21a Typhoid Fever Vaccine

All participants will receive the vaccine. One capsule is swallowed on alternate days, e.g. days 30, 32, 34, and 36 for a total of 4 capsules.

Sponsors & Collaborators

• University of Minnesota

  collaborator OTHER

• USDA, Western Human Nutrition Research Center

  lead FED

Principal Investigators

• Danielle Lemay, PhD · USDA, ARS, Western Human Nutrition Research Center

• Ryan Snodgrass, PhD · USDA, ARS, Western Human Nutrition Research Center

• Mary Kable, PhD · USDA, ARS, Western Human Nutrition Research Center

• Bess Caswell, PhD · USDA, ARS, Western Human Nutrition Research Center

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

59 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-09-27

Primary Completion

2025-06-11

Completion

2025-06-11

FDA Drug

Yes

Countries

• United States

Study Locations