NCT05565586

Impact of High Dietary Fiber on Microbiome and Vaccine Responses

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

To learn if diet can enhance the microbes (such as bacteria and viruses) found in your gut and improve the body's immune response to the influenza (flu) vaccine.

Detailed description

Primary Objectives: --To determine the feasibility of two dietary intervention strategies focused on fiber-rich and prebiotic foods prior to seasonal influenza vaccination. Feasibility is defined as ≥ 80% of subjects being compliant with the intervention. Secondary Objectives: * To evaluate the effects of each dietary intervention on the composition, diversity and function of the gut microbiome. * To assess the effects of each dietary intervention on response to influenza vaccination as measured by vaccine-specific immune response. * To assess the effects of each dietary intervention on systemic immunity. Exploratory Objectives: * To interrogate the overlap between the identified gut microbial and dietary patterns associated with vaccine response and those associated with excellent or poor responses to cancer immunotherapy (from our own published work and internal cohorts). * To identify components and determinants of the gut microbiome that could be modulated to enhance vaccine response. * To determine how modulation of the gut microbiome can be achieved through fiber and prebiotic-focused dietary changes.

Conditions

• Influenza

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	High-Fiber Diet (HFD)	Participants are assigned to the high fiber diet, all meals and snacks will be provided to participants during the study. This diet includes fruits, vegetables and whole grains, a maximum of 18 oz. cooked red meat (including beef, pork, and lamb) per week, and little or no processed meats or added sugars.
DIETARY_SUPPLEMENT	Prebiotic Food-Enriched Diet (PreFED)	Participants are assigned to the prebiotic food enriched diet, participants will receive 2 prepared snacks and 1 meal component (a key prebiotic ingredient to incorporate into meals and simple recipes) each day. Participants will also receive a handout that includes key prebiotic foods to incorporate into your own diet.

Timeline

• Start date: 2022-08-23
• Primary completion: 2029-01-02
• Completion: 2029-01-02
• First posted: 2022-10-04
• Last updated: 2026-03-04

Locations

1 site across 1 country: United States