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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2022-07926 | Other Identifier | NCI-CTRP Clinical Trials Registry |
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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.
Primary Objectives:
--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.
Secondary Objectives:
Exploratory Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-Fiber Diet (HFD) Intervention | Experimental | Participants are expected to eat only the study meals and snacks provided |
|
| Prebiotic Food-Enriched Diet (PreFED) Intervention | Experimental | Participants are expected to incorporate study snacks and meal components provided into your usual diet. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Wargo, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| M D Anderson Cancer Center | View source |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| 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. |
|
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |