InfluenzaNCT05565586
Impact of High Dietary Fiber on Microbiome and Vaccine Responses
A study testing High-Fiber Diet (HFD) and Prebiotic Food-Enriched Diet (PreFED) in people with Influenza, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- High-Fiber Diet (HFD) and Prebiotic Food-Enriched Diet (PreFED)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2022to 2 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Influenza
- Being tested
- High-Fiber Diet (HFD), Prebiotic Food-Enriched Diet (PreFED)
- Keywords
- Microbiome, Flu, Fiber, Vaccination
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| High-Fiber Diet (HFD) Intervention | Experimental | Participants are expected to eat only the study meals and snacks provided Receives: Dietary Supplement: High-Fiber Diet (HFD) |
| Prebiotic Food-Enriched Diet (PreFED) Intervention | Experimental | Participants are expected to incorporate study snacks and meal components provided into your usual diet. Receives: Dietary Supplement: Prebiotic Food-Enriched Diet (PreFED) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of dietary intervention prior to seasonal influenza vaccination defined as ≥ 80% of subjects being compliant with the intervention in the cohort
Measured: through study completion an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start23 Aug 2022
- Primary completion2 Jan 2029 (estimated)
- Study completion2 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Wargo, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05565586
- Sponsor's protocol ID
- 2022-0450
- Other IDs
- NCI-2022-07926
- Status last verified
- Aug 2026
- First submitted
- 19 Sep 2022
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of High Dietary Fiber on Microbiome and Vaccine Responses
- ClinicalTrials.gov ID
- NCT05565586
- Acronym / sponsor ID
- 2022-0450
- Conditions
- Influenza
- Keywords
- Microbiome, Flu, Fiber, Vaccination
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 31 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 23 Aug 2022 (actual)
- Primary completion
- 2 Jan 2029 (estimated)
- Study completion
- 2 Jan 2029 (estimated)
- First posted
- 4 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-Fiber Diet (HFD) Intervention | Experimental | Dietary Supplement: High-Fiber Diet (HFD)Participants are expected to eat only the study meals and snacks provided |
| Prebiotic Food-Enriched Diet (PreFED) Intervention | Experimental | Dietary Supplement: Prebiotic Food-Enriched Diet (PreFED)Participants are expected to incorporate study snacks and meal components provided into your usual diet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-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 supplement | High-Fiber Diet (HFD) Intervention |
| Prebiotic 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. | Dietary supplement | Prebiotic Food-Enriched Diet (PreFED) Intervention |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- M D Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Wargo, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Fiber Diet (HFD) and Prebiotic Food-Enriched Diet (PreFED) in people with Influenza, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.