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Active, not recruitingNCT05565586Updated Aug 14, 2026

Impact of High Dietary Fiber on Microbiome and Vaccine Responses

An interventional study of High-Fiber Diet (HFD) and Prebiotic Food-Enriched Diet (PreFED) in Influenza, sponsored by M.D. Anderson Cancer Center. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-14.

Sponsored by M.D. Anderson Cancer Center · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
31
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Influenza

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Keywords

  • Microbiome
  • Flu
  • Fiber
  • Vaccination
03

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.

This study's enrollment of 31 is below the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.

Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
31 participants (actual)

Study arms

  • Experimental
    High-Fiber Diet (HFD) Intervention

    Participants are expected to eat only the study meals and snacks provided

    Dietary Supplement: High-Fiber Diet (HFD)

  • 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)

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.

06

What researchers measure

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.

07

Study locations

1 site
  • M D Anderson Cancer Center
    Houston, Texas 77030, United States
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References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05565586
Lead sponsor
M.D. Anderson Cancer Center
Responsible party
Sponsor
First posted
Oct 4, 2022
Start date
Aug 23, 2022
Primary completion
Jan 2, 2029 (estimated)
Completion
Jan 2, 2029 (estimated)
Last update
Aug 14, 2026

Study contacts

Jennifer Wargo, MD
principal investigator · M.D. Anderson Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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