Snack Foods and Their Impact on the Immune Response Following Influenza Vaccination

Launched by KING'S COLLEGE LONDON · Aug 24, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at how changing the snacks that healthy middle-aged adults eat might affect their immune response after getting an influenza vaccine. The researchers want to see if replacing regular snacks with different options can help the body respond better to the vaccine, which is important for staying healthy during flu season.

To qualify for the study, participants need to be between 40 and 64 years old, have a body mass index (BMI) between 18.5 and 29.9, and eat at least two snacks a day (but not including fruits, vegetables, nuts, or seeds). They should not have any serious health conditions or be taking medications that weaken the immune system. Those who join the trial will need to avoid other vaccinations and certain dietary supplements during the study period. Participants can expect to follow a specific snack plan for eight weeks while monitoring their immune response to the flu vaccine. This trial is currently recruiting, so it's a great opportunity for eligible individuals to contribute to important research on nutrition and immunity.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Men or women, aged between 40-64 years
• • 2. Body mass index (BMI) of 18.50 - 29.99 kg/m2
• • 3. Individuals who regularly consume snacks (≥2 per day, excluding fruit, vegetable, nut and seed snacks)
• • 4. Fibre intake \<30 g/d
• • 5. Willing to avoid receiving any vaccination (except for COVID-19 vaccination) from one month prior to the baseline visit until completion of the 8-week intervention period
• • 6. Willing to avoid receiving any COVID-19 vaccination/booster between week 2 and week 8 of the intervention period
• • 7. Willing to discontinue use of prebiotics and probiotics during the trial
• • 8. Willing to follow the protocol and provide consent
• Exclusion Criteria:
• • 1. Allergy or intolerance to any intervention products
• • 2. Dislike of any intervention products
• 3. Immunodeficiency/immunosuppression due to disease or medication, such as:
• • Chronic inflammatory disease or autoimmune disease (e.g., rheumatoid arthritis, inflammatory bowel disease, psoriasis) or primary or secondary immunodeficiency disease (e.g., HIV infection)
• • Ongoing therapy with immunomodulators or immunosuppressants (e.g., chemotherapy, oral corticosteroids, daily use of inhaled or nasal corticosteroids)
• • Other immunodeficient state (e.g., asplenia).
• • 4. Medical history of any of the following: diabetes, major active psychiatric conditions (e.g. schizophrenia), current eating disorder, alcohol abuse, active treatment for cancer in the last year, severe neurological, endocrine, renal, cardiac or pulmonary disease (or any other chronic medical condition), severe oesophagitis, gastritis or duodenitis, active diverticulitis or intestinal/colonic strictures, Coeliac disease, Crohn's disease or Ulcerative colitis, stem cell or organ transplant, gut resection surgery, bleeding disorder, anaphylaxis or any other major or chronic condition known to impact study outcome measures.
• • 5. Ongoing use of antiviral agents, or any other drugs known to impact study outcome measures
• • 6. Use of immunoglobulins and/or any blood products within the three months prior to vaccination
• • 7. Ongoing use of anticoagulants (e.g., warfarin)
• • 8. Antibiotic treatment in the month prior to the start of the study
• • 9. Consumption of probiotics or prebiotic products within the four weeks prior to the start of the study
• • 10. History of severe adverse reaction and/or allergic reaction associated with the influenza vaccine or any other vaccine
• • 11. Known allergy or hypersensitivity to any component of the vaccine including: sodium chloride, potassium chloride, magnesium chloride hexahydrate, disodium phosphate dihydrate, potassium dihydrogen phosphate; and possible trace residues: beta-propiolactone, cetyltrimethylammonium bromide, and polysorbate 80
• • 12. Suffered from influenza illness in the six months prior to the start of the study
• • 13. For participants recruited on or before 30/06/2023, exclusion criteria is: already vaccinated with any influenza vaccine licensed for the 2022/2023 season; For participants recruited after 30/06/2023, exclusion criteria is: already vaccinated with any influenza vaccine licensed for the 2023/2024 season
• • 14. Received any influenza vaccination within six months prior to the start of the study
• • 15. Received any other vaccinations within one month prior to the start of the study (except for COVID-19 vaccination)
• • 16. Women who are pregnant, lactating or planning pregnancy
• • 17. Ongoing alcohol, drug or medication abuse
• • 18. Unexplained or unintentional weight loss in the past six months