High-Fiber Diet for Flu Vaccine Response

Overseen By Jennifer Wargo, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Antibiotics, Fiber supplements

Disqualifiers: Diabetes, Inflammatory bowel disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

31 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are taking antibiotics or fiber/prebiotic/probiotic supplements, you must stop at least 30 days before starting the study.

What data supports the effectiveness of the high-fiber diet treatment for improving flu vaccine response?

Research suggests that a high-fiber diet, which includes prebiotics, can enhance the immune response to the flu vaccine by improving gut health and increasing beneficial bacteria. This can lead to better antibody responses, as seen in studies with elderly patients and animal models. ^{1 2 3 4 5}

Is a high-fiber diet generally safe for humans?

High-fiber diets are generally considered safe for humans and are often recommended for their health benefits, such as improving gut health and increasing fecal bulk. However, they can sometimes affect digestion and metabolism, so it's important to introduce them gradually and consult with a healthcare provider if you have specific health conditions. ^{2 6 7 8 9}

How does the High-Fiber Diet treatment for flu vaccine response differ from other treatments?

The High-Fiber Diet treatment is unique because it enhances the immune response to the flu vaccine by promoting beneficial gut bacteria and producing short-chain fatty acids, which improve immune function. This approach is different from traditional treatments that do not focus on dietary modifications to boost vaccine efficacy. ^{2 3 4 5 10}

Research Team

Jennifer Wargo, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

Willing to adhere to the provided dietary interventions

English-speaking

Has easy access to a scale at home, work, or in their community

Exclusion Criteria

Major dietary restrictions (including vegetarian or vegan diets) or food allergies

I have had major surgery on my digestive system, not counting surgery to remove my appendix or gallbladder.

I have health conditions that prevent me from following the study's diet.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dietary Intervention

Participants follow either a high-fiber diet or a prebiotic food-enriched diet prior to influenza vaccination

4-6 weeks

Vaccination

Participants receive the seasonal influenza vaccine

1 day

Follow-up

Participants are monitored for immune response and changes in gut microbiome after vaccination

4 weeks

Treatment Details

Interventions

• High-Fiber Diet (HFD)
• Prebiotic Food-Enriched Diet (PreFED)

Trial Overview 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.

Participant Groups

Group I: Prebiotic Food-Enriched Diet (PreFED) Intervention Experimental Treatment 1 Intervention

Participants are expected to incorporate study snacks and meal components provided into your usual diet.

Group II: High-Fiber Diet (HFD) Intervention Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Findings from Research

In a study involving enterally fed elderly individuals, prebiotics in the diet led to an increase in beneficial gut bacteria, such as Bifidobacterium and Bacteroides, compared to a control group without prebiotics over a 10-week period.

The group receiving prebiotics maintained higher antibody titers against influenza vaccine strains (H1N1, H3N2) compared to the control group, suggesting that prebiotics may enhance the immunological response to vaccination in the elderly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced vaccination effect against influenza by prebiotics in elderly patients receiving enteral nutrition. Akatsu, H., Nagafuchi, S., Kurihara, R., et al.[2022]

A high-fiber diet (HFD) for about 4 months in men with type 1 diabetes significantly reduced whole-body protein turnover, decreasing both protein degradation and synthesis by approximately 20% and 25%, respectively.

Despite these changes in protein metabolism, the HFD did not negatively impact insulin sensitivity, glucose disposal, or overall metabolic control, indicating that a high-fiber diet can be safely integrated into the management of type 1 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A High-Fiber Diet Decreases Postabsorptive Protein Turnover but Does Not Alter Insulin Sensitivity in Men with Type 1 Diabetes Mellitus. Bruttomesso, D., Tessari, P.[2023]

A high-fiber diet increased survival rates in influenza-infected mice by enhancing the production of specific immune cells, which helped reduce harmful inflammation in the airways.

Diet-derived short-chain fatty acids (SCFAs) improved the function of CD8+ T cells, promoting effective immune responses while preventing excessive tissue damage during the infection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary Fiber Confers Protection against Flu by Shaping Ly6c- Patrolling Monocyte Hematopoiesis and CD8+ T Cell Metabolism. Trompette, A., Gollwitzer, ES., Pattaroni, C., et al.[2019]

In a study of 24 elderly in-patients over 14 weeks, a formula containing prebiotics and fermented milk products significantly increased Bifidobacterium counts and maintained higher antibody titers against the A/H1N1 influenza strain compared to a standard formula.

While the prebiotic formula did not affect antibody responses to A/H3N2 and resulted in lower titers against B, the overall findings suggest that improving intestinal microbiota with prebiotics may enhance the duration of immune response to certain vaccines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Formula Containing Two Types of Prebiotics, Bifidogenic Growth Stimulator and Galacto-oligosaccharide, and Fermented Milk Products on Intestinal Microbiota and Antibody Response to Influenza Vaccine in Elderly Patients: A Randomized Controlled Trial. Nagafuchi, S., Yamaji, T., Kawashima, A., et al.[2022]

Dietary fiber intake may enhance immune responses to influenza vaccination, particularly in first-time vaccinees, suggesting that gut health could influence vaccine efficacy.

In animal studies, increased dietary fiber led to improved vaccine responses through the production of short-chain fatty acids, indicating a potential mechanism for how diet affects vaccine effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential Association Between Dietary Fibre and Humoral Response to the Seasonal Influenza Vaccine. Cait, A., Mooney, A., Poyntz, H., et al.[2022]

Dietary fiber has been recognized for its positive health effects since the 1970s, and certain types of fiber, known as prebiotics, can enhance the activity of beneficial gut bacteria.

Studying the metabolites produced from the fermentation of dietary fiber in the colon may provide clearer insights into how fiber contributes to health benefits, potentially helping to close the gap between recommended and actual fiber intake among consumers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prebiotics, Fermentable Dietary Fiber, and Health Claims. Delcour, JA., Aman, P., Courtin, CM., et al.[2018]

In a study involving 38 participants over 7 weeks, resistant maltodextrin was well tolerated and led to a slight increase in beneficial Bifidobacterium populations, suggesting potential prebiotic effects.

Supplementation with resistant maltodextrin shifted the production of short-chain fatty acids (SCFA) towards butyrate, which is beneficial for colon health, indicating favorable fermentation characteristics in the gut.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel resistant maltodextrin alters gastrointestinal tolerance factors, fecal characteristics, and fecal microbiota in healthy adult humans. Fastinger, ND., Karr-Lilienthal, LK., Spears, JK., et al.[2019]

Polylactose, a novel prebiotic fiber, was found to be highly fermentable and significantly increased the abundance of beneficial Bifidobacterium in the gut microbiota of rats on a high-fat diet, indicating its potential to improve gut health.

Rats fed polylactose showed a 29% reduction in epididymal fat pad weight and lower liver lipids compared to those on a high-fat diet without polylactose, suggesting it may help reduce obesity-related health risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Polylactose Exhibits Prebiotic Activity and Reduces Adiposity and Nonalcoholic Fatty Liver Disease in Rats Fed a High-Fat Diet. Abernathy, BE., Schoenfuss, TC., Bailey, AS., et al.[2023]

In a study involving 29 participants, adding 10 g of extrinsic wheat fiber to solid food significantly increased fecal bulk, indicating a beneficial effect on digestive health.

However, when the same amount of fiber was consumed in the form of drinks, it did not lead to a significant change in fecal bulk, suggesting that the form of fiber intake matters for its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Extrinsic Wheat Fiber Supplementation on Fecal Weight; A Randomized Controlled Trial. Brandl, B., Lee, YM., Dunkel, A., et al.[2020]

A study by Trompette et al. demonstrated that dietary fiber and short-chain fatty acids can improve the immune response to influenza A virus by enhancing the function of CD8+ T cells.

These dietary components also promote the differentiation of alternatively activated macrophages, which may help reduce inflammation and tissue damage during viral infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Little Fiber Goes a Long Way. Castillo, PAC., Hand, TW.[2019]

References

1. Japan pubmed.ncbi.nlm.nih.gov

Enhanced vaccination effect against influenza by prebiotics in elderly patients receiving enteral nutrition. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

A High-Fiber Diet Decreases Postabsorptive Protein Turnover but Does Not Alter Insulin Sensitivity in Men with Type 1 Diabetes Mellitus. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Dietary Fiber Confers Protection against Flu by Shaping Ly6c- Patrolling Monocyte Hematopoiesis and CD8+ T Cell Metabolism. [2019]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of a Formula Containing Two Types of Prebiotics, Bifidogenic Growth Stimulator and Galacto-oligosaccharide, and Fermented Milk Products on Intestinal Microbiota and Antibody Response to Influenza Vaccine in Elderly Patients: A Randomized Controlled Trial. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Potential Association Between Dietary Fibre and Humoral Response to the Seasonal Influenza Vaccine. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Prebiotics, Fermentable Dietary Fiber, and Health Claims. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

A novel resistant maltodextrin alters gastrointestinal tolerance factors, fecal characteristics, and fecal microbiota in healthy adult humans. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Polylactose Exhibits Prebiotic Activity and Reduces Adiposity and Nonalcoholic Fatty Liver Disease in Rats Fed a High-Fat Diet. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of Extrinsic Wheat Fiber Supplementation on Fecal Weight; A Randomized Controlled Trial. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

A Little Fiber Goes a Long Way. [2019]