Impact of High Dietary Fiber on Microbiome and Vaccine Responses

Influenza Clinical Trial

Official title:

Impact of High Dietary Fiber on Microbiome and Vaccine Responses

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05565586
• Other study ID #: 2022-0450
• Secondary ID: NCI-2022-07926
• Status: Recruiting
• Phase: N/A
• Start date: August 23, 2022
• Est. completion date: January 2, 2029

Study information

• Verified date: May 2024
• Source: M.D. Anderson Cancer Center
• Contact: Jennifer Wargo, MD
• Phone: (713) 745-1553
• Email: jwargo[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: January 2, 2029
• Est. primary completion date: January 2, 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Influenza

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.

External Links

•   M D Anderson Cancer Center