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Fiber Supplement

High-Fiber Diet for Flu Vaccine Response

N/A
Recruiting
Led By Jennifer Wargo, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion an average of 1 year.
Awards & highlights

Study Summary

This trial will test if eating a certain type of food can improve the body's response to the flu vaccine.

Who is the study for?
This trial is for English-speaking MD Anderson employees aged 18 or older with a BMI of 18.5-40, who plan to get the flu vaccine there and can provide blood and stool samples. Participants must not have major dietary restrictions, diabetes needing treatment, inflammatory bowel disease, history of significant gut surgery, recent antibiotic use or be pregnant.Check my eligibility
What is being tested?
The study tests if a High-Fiber Diet (HFD) or Prebiotic Food-Enriched Diet (PreFED) can boost gut microbes and improve immune response to the flu vaccine. Participants will follow assigned diets, complete questionnaires/logs, and submit specimens.See study design
What are the potential side effects?
Potential side effects may include digestive changes like bloating or discomfort due to increased fiber intake from the diets being tested.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion an average of 1 year.
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion an average of 1 year. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility of dietary intervention prior to seasonal influenza vaccination defined as ≥ 80% of subjects being compliant with the intervention in the cohort

Trial Design

2Treatment groups
Experimental Treatment
Group I: Prebiotic Food-Enriched Diet (PreFED) InterventionExperimental Treatment1 Intervention
Participants are expected to incorporate study snacks and meal components provided into your usual diet.
Group II: High-Fiber Diet (HFD) InterventionExperimental Treatment1 Intervention
Participants are expected to eat only the study meals and snacks provided

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,972 Previous Clinical Trials
1,787,285 Total Patients Enrolled
Jennifer Wargo, MDPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

High-Fiber Diet (HFD) (Fiber Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT05565586 — N/A
Microbiome Research Study Groups: High-Fiber Diet (HFD) Intervention, Prebiotic Food-Enriched Diet (PreFED) Intervention
Microbiome Clinical Trial 2023: High-Fiber Diet (HFD) Highlights & Side Effects. Trial Name: NCT05565586 — N/A
High-Fiber Diet (HFD) (Fiber Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05565586 — N/A
Microbiome Patient Testimony for trial: Trial Name: NCT05565586 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals have volunteered to be a part of this research endeavor?

"True, the clinical trial is currently in progress with signup information indicated on clinicaltrials.gov. This study was originally posted on August 23rd 2022 and recently updated on October 3rd of that same year. 32 participants are being sought from a single medical centre."

Answered by AI

Is there a possibility for enrolment in this clinical experiment?

"Per clinicaltrials.gov, this research initiative is actively seeking volunteers. It was initially announced on August 23rd 2022 and recently revised on October 3rd 2022."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
M D Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I support any intervention that makes vaccines more effective.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

Recent research and studies
clinicaltrials.govStudy
Impact of High Dietary Fiber on Microbiome and Vaccine Responses
2022. "Impact of High Dietary Fiber on Microbiome and Vaccine Responses". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05565586.
All > Influenza
~21 spots leftby Jan 2029
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