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OpenTrials
Active, Not Recruiting

NCT Number: NCT05565586

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • English-speaking
  • 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
  • Use of a supplement containing fiber/prebiotics/probiotics within 30 days of study initiation
  • Women who are pregnant, planning to become pregnant, or who are lactating may not be included in this study

Treatment and study plan

High-Fiber Diet (HFD)

Dietary Supplement

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)

Dietary Supplement

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.

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Important dates

Study start
2022
Primary completion
2029
Study completion
2029
First posted
Oct 4, 2022
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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