Impact of High Dietary Fiber on Microbiome and Vaccine Responses
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05565586|
Recruitment Status : Recruiting
First Posted : October 4, 2022
Last Update Posted : November 7, 2023
|Condition or disease||Intervention/treatment||Phase|
|Microbiome Flu||Dietary Supplement: High-Fiber Diet (HFD) Dietary Supplement: Prebiotic Food-Enriched Diet (PreFED)||Not Applicable|
--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.
- 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.
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Impact of High Dietary Fiber on Microbiome and Vaccine Responses|
|Actual Study Start Date :||August 23, 2022|
|Estimated Primary Completion Date :||January 2, 2029|
|Estimated Study Completion Date :||January 2, 2029|
Experimental: High-Fiber Diet (HFD) Intervention
Participants are expected to eat only the study meals and snacks provided
Dietary Supplement: 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.
Experimental: Prebiotic Food-Enriched Diet (PreFED) Intervention
Participants are expected to incorporate study snacks and meal components provided into your usual diet.
Dietary Supplement: 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.
- 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. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05565586
|Contact: Jennifer Wargo, MD||(713) firstname.lastname@example.org|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Jennifer Wargo, MD 713-745-1553 email@example.com|
|Principal Investigator: Jennifer Wargo, MD|
|Principal Investigator:||Jennifer Wargo, MD||M.D. Anderson Cancer Center|