Impact of High Dietary Fiber on Microbiome and Vaccine Responses

• ClinicalTrials.gov Identifier: NCT05565586
• Recruitment Status: Recruiting
• First Posted: October 4, 2022
• Last Update Posted: November 7, 2023
• Sponsor: M.D. Anderson Cancer Center
• Information provided by (Responsible Party): M.D. Anderson Cancer Center

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Microbiome; Flu	Dietary Supplement: High-Fiber Diet (HFD); Dietary Supplement: Prebiotic Food-Enriched Diet (PreFED)	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Impact of High Dietary Fiber on Microbiome and Vaccine Responses
• Actual Study Start Date: August 23, 2022
• Estimated Primary Completion Date: January 2, 2029
• Estimated Study Completion Date: January 2, 2029

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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 or supplement containing fiber/prebiotics/probiotics

Women who are pregnant, planning to become pregnant, or who are lactating may not be included in this study.

Contacts and Locations

Contacts

Contact: Jennifer Wargo, MD; (713) 745-1553; jwargo@mdanderson.org

Locations

United States, Texas

M D Anderson Cancer Center; Recruiting

Houston, Texas, United States, 77030

Contact: Jennifer Wargo, MD 713-745-1553 jwargo@mdanderson.org

Principal Investigator: Jennifer Wargo, MD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

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

More Information

Additional Information:

M D Anderson Cancer Center 

• Responsible Party: M.D. Anderson Cancer Center
• ClinicalTrials.gov Identifier: NCT05565586
• Other Study ID Numbers: 2022-0450; NCI-2022-07926 ( Other Identifier: NCI-CTRP Clinical Trials Registry )
• First Posted: October 4, 2022
• Last Update Posted: November 7, 2023
• Last Verified: November 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No