Impact of High Dietary Fiber on Microbiome and Vaccine Responses

  • End date
    Jan 2, 2029
  • participants needed
  • sponsor
    M.D. Anderson Cancer Center
Updated on 20 October 2022


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.


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.

Condition Microbiome, Flu
Treatment High-Fiber Diet (HFD), Prebiotic Food-Enriched Diet (PreFED)
Clinical Study IdentifierNCT05565586
SponsorM.D. Anderson Cancer Center
Last Modified on20 October 2022


Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

Contraindication to the recommended annual influenza vaccine
Medical contraindications to the intervention diet
Major dietary restrictions (including vegetarian or vegan diets) or food allergies
Unable or unwilling to undergo study procedures
Has diabetes mellitus requiring medical treatment
Has inflammatory bowel disease
Has a history of bariatric surgery
Has a history of major gastrointestinal surgery (not including appendectomy or cholecystectomy)
Antibiotic use within 30 days of study initiation or planned antibiotic treatment during study course
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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