WHNRC (Western Human Nutrition Research Center) Fiber Intervention Study

Description

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

Study Overview

Study Details

Study overview

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.

WHNRC (Western Human Nutrition Research Center) Fiber Intervention Study

WHNRC (Western Human Nutrition Research Center) Fiber Intervention Study

Condition
Inflammation
Intervention / Treatment

-

Contacts and Locations

Davis

USDA, ARS, Western Human Nutrition Research Center, Davis, California, United States, 95616

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Body Mass Index (BMI) 18.5 - 30.9 kg/m2
  • 2. inadequate total dietary fiber intake defined as:
  • * Females 18 - 30 years old, less than 28 g/day
  • * Females 31 - 50 years old, less than 25 g/day
  • * Males 18 - 30 years old, less than 34 g/day
  • * Males 31 - 50 years old, less than 31 g/day
  • 1. blood pressure greater than or equal to 140/90 mmHg
  • 2. has HIV/AIDS or another disease that affects the immune system
  • 3. has any kind of cancer
  • 4. inability to lift 30 pounds with assistance (for transporting refrigerated stool containers)
  • 5. decline to take an HIV blood test
  • 6. pregnant or lactating women
  • 7. refusal to take a pregnancy test
  • 8. female subjects: refusal to use a method of birth control 1 week prior to the administration of the vaccine, 1 week during the vaccine, and 1 week after the vaccine
  • 9. allergy to vaccine components, i.e. thimerosal and enteric-coated capsules
  • 10. allergy to oral typhoid vaccine
  • 11. use of anti-inflammatory medications, i.e. nonsteroidal anti-inflammatory drugs (NSAID), aspirin, 3 or more times per month
  • 12. use of sulfonamides or antibiotics 3 months prior to the receipt of Ty21a vaccine.
  • 13. use of anti-hypertensive drugs, i.e. beta blockers, diuretics, calcium channel blockers
  • 14. use of anti-malaria drugs, i.e. mefloquine, chloroquine, and proguanil
  • 15. use of drugs that affects the immune system, i.e. immunosuppressants, immune-modifying drugs, corticosteroids, i.e. cortisone, prednisone, methylprednisolone, for 2 weeks or longer
  • 16. use of biologics, i.e. Lantus, Remicade, Rituxan, Humira, Herceptin, Avastin, Lucentis, Enbrel for 2 weeks or longer
  • 17. undergoing cancer treatment with radiation or drugs
  • 18. greater than 10 years residence in a typhoid-endemic area
  • 19. receipt of typhoid vaccine in the last 5 years
  • 20. receipt of any vaccine two weeks prior to receipt of Ty21a vaccine
  • 21. individuals at increased risk of developing complications from a live, bacterial vaccine
  • 22. history of typhoid fever
  • 23. history of primary immune deficiency or autoimmune disease
  • 24. history of acute or chronic gastrointestinal (GI) disorder, i.e. Crohn's disease, irritable bowel syndrome, gastric ulcer
  • 25. diarrheal illness (defined as passing 3 or more abnormally loose or watery stool in a 24 hour period) or persistent vomiting 2 weeks prior to the study
  • 26. history of chronic illnesses, i.e. diabetes, cardiovascular disease, cancer, gastrointestinal malabsorption or inflammatory diseases, kidney disease, autoimmune disorders, HIV, liver disease, including hepatitis B and C
  • 27. asthma if taking medication on a daily basis
  • 28. recent surgery (within 3 months)
  • 29. history of GI surgery
  • 30. recent hospitalization (within 3 months)
  • 31. fever (within 2 weeks)
  • 32. unwillingness to discontinue probiotic, prebiotic, or other supplements (except Recommended Dietary Allowance-level vitamin and mineral supplements), fiber supplements, or food and beverage products containing inulin, chicory root fiber, or maltodextrin during the study
  • 33. not having at least one arm vein suitable for blood drawing
  • 34. unwilling or uncomfortable with blood draws and stool collections
  • 35. regular blood or blood product donation and refusal to suspend donation
  • 36. current participation in another research study
  • 37. unable to fast for 12-16 hours
  • 38. have fewer than 3 bowel movements per week
  • 39. consuming one or more servings of added-inulin foods per day over the past month

Ages Eligible for Study

18 Years to 50 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

USDA, Western Human Nutrition Research Center,

Danielle Lemay, PhD, PRINCIPAL_INVESTIGATOR, USDA, ARS, Western Human Nutrition Research Center

Charles Stephensen, PhD, PRINCIPAL_INVESTIGATOR, USDA, ARS, Western Human Nutrition Research Center

Mary Kable, PhD, PRINCIPAL_INVESTIGATOR, USDA, ARS, Western Human Nutrition Research Center

Study Record Dates

2025-09-30