Impact of High Dietary Fiber on Microbiome and Vaccine Responses (NCT05565586) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.