Influenza
Conditions
Keywords
Microbiome, Flu, Fiber, Vaccination
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.
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.
Interventions
DIETARY_SUPPLEMENTHigh-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_SUPPLEMENTPrebiotic 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.
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJennifer Wargo, MD
M.D. Anderson Cancer Center
Outcome results
None listed