NCT05565586

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
31mo left

Started Aug 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress60%
Aug 2022Jan 2029

Study Start

First participant enrolled

August 23, 2022

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

September 19, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 4, 2022

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2029

Last Updated

March 4, 2026

Status Verified

March 1, 2026

Enrollment Period

6.4 years

First QC Date

September 19, 2022

Last Update Submit

March 2, 2026

Conditions

Influenza

Keywords

MicrobiomeFluFiberVaccination

Outcome Measures

Primary Outcomes (1)

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

    through study completion an average of 1 year.

Study Arms (2)

High-Fiber Diet (HFD) Intervention

EXPERIMENTAL

Participants are expected to eat only the study meals and snacks provided

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.

Dietary Supplement: Prebiotic Food-Enriched Diet (PreFED)

Interventions

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.

High-Fiber Diet (HFD) Intervention
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.

Prebiotic Food-Enriched Diet (PreFED) Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Jennifer Wargo, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2022

First Posted

October 4, 2022

Study Start

August 23, 2022

Primary Completion (Estimated)

January 2, 2029

Study Completion (Estimated)

January 2, 2029

Last Updated

March 4, 2026

Record last verified: 2026-03

Locations

US(1)