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Fiber-Fueled immunity: could your diet boost the flu shot?

NCT ID NCT05565586

Knowledge-focused Sponsor: M.D. Anderson Cancer Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Aug 14, 2026 · Updated 3 times

Summary

This study looks at whether eating a high-fiber diet (rich in fruits, vegetables, and whole grains) can change the bacteria in your gut and improve how well the flu vaccine works. Researchers will give 31 adults special meals and snacks before they get their flu shot. The main goal is to see if people can stick to the diet, not yet to prove it boosts immunity.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
High-fiber diet (fruits, vegetables, whole grains)
What this could lead to
If successful, this could show that a simple diet change may help vaccines work better.
What could go wrong
This is a very small, early study with only 31 participants, so results may not apply to everyone. It only tests feasibility, not whether the diet actually improves vaccine protection.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

31 people

The number who actually took part.

Started

Aug 2022

Expected to finish

Jan 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

influenza prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Influenza

Contacts and locations

Locations

  • M D Anderson Cancer Center

    Houston, Texas, 77030, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.