WHNRC (Western Human Nutrition Research Center) Fiber Intervention Study

Status: Completed
Location: See location...
Intervention Type: Dietary supplement, Biological
Study Type: Interventional
Study Phase: Early Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 59
Healthy Volunteers: t
View:

• Body Mass Index (BMI) 18.5 - 30.9 kg/m2

• inadequate total dietary fiber intake defined as:

‣ Females 18 - 30 years old, less than 28 g/day

⁃ Females 51+ year old, less than 22 g/day

⁃ Males 18 - 30 years old, less than 34 g/day

Locations
United States
California
USDA, ARS, Western Human Nutrition Research Center
Davis
Time Frame
Start Date: 2022-09-27
Completion Date: 2025-06-11
Participants
Target number of participants: 60
Treatments
Experimental: Inulin and Ty21a Vaccine
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.
Placebo_comparator: Maltodextrin and Ty21a Vaccine
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.
Authors
Charles Stephensen
Related Therapeutic Areas
Sponsors
Leads: USDA, Western Human Nutrition Research Center
Collaborators: University of Minnesota

This content was sourced from clinicaltrials.gov