Impact of High Dietary Fiber on Microbiome and Vaccine Responses

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Influenza
• Intervention / Treatment: Dietary supplement: High-Fiber Diet (HFD); Dietary supplement: Prebiotic Food-Enriched Diet (PreFED)

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.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. MD Anderson employees with existing MRNs
2. Body Mass Index (BMI) 18.5-40 kg/m2
3. Age 18 or older
4. Intends to receive the seasonal influenza vaccine at MD Anderson through Employee Health (starting Fall of 2022)
5. Willing to adhere to the provided dietary interventions
6. Willing to provide blood and stool specimens, complete diet questionnaires and logs, and pick up food on-site within the study schedule
7. English-speaking
8. Has easy access to a scale at home, work, or in their community

Exclusion Criteria:

1. Contraindication to the recommended annual influenza vaccine
2. Medical contraindications to the intervention diet
3. Major dietary restrictions (including vegetarian or vegan diets) or food allergies
4. Unable or unwilling to undergo study procedures
5. Has diabetes mellitus requiring medical treatment
6. Has inflammatory bowel disease
7. Has a history of bariatric surgery
8. Has a history of major gastrointestinal surgery (not including appendectomy or cholecystectomy)
9. Antibiotic use within 30 days of study initiation or planned antibiotic treatment during study course
10. Habitual consumption of a high fiber diet
11. Use of a supplement containing fiber/prebiotics/probiotics within 30 days of study initiation
12. Women who are pregnant, planning to become pregnant, or who are lactating may not be included in this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High-Fiber Diet (HFD) Intervention; Participants are expected to eat only the study meals and snacks provided	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.
Experimental: Prebiotic Food-Enriched Diet (PreFED) Intervention; Participants are expected to incorporate study snacks and meal components provided into your usual diet.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Feasibility of dietary intervention prior to seasonal influenza vaccination defined as ≥ 80% of subjects being compliant with the intervention in the cohort	through study completion an average of 1 year.

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Jennifer Wargo, MD, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• M D Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2022
• Primary Completion (Estimated): January 2, 2029
• Study Completion (Estimated): January 2, 2029

Study Registration Dates

• First Submitted: September 19, 2022
• First Submitted That Met QC Criteria: October 3, 2022
• First Posted (Actual): October 4, 2022

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Microbiome; Fiber; Vaccination; Flu
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Influenza, Human
• Other Study ID Numbers: 2022-0450; NCI-2022-07926 (Other Identifier: NCI-CTRP Clinical Trials Registry)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No