Active — Not RecruitingNot Applicable

Impact of High Dietary Fiber on Microbiome and Vaccine Responses

United States31 participantsStarted 2022-08-23

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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)

What they're measuring

Feasibility of dietary intervention prior to seasonal influenza vaccination defined as ≥ 80% of subjects being compliant with the intervention in the cohort

Timeframe: through study completion an average of 1 year.

Trial details

NCT IDNCT05565586

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-01-02

View on ClinicalTrials.gov More Influenza trials