Clinical trial NCT05515263: Snack Foods and Their Impact on the Immune Response Following Influenza Vaccination
Official title: Snack Foods and Their Impact on Immune Optimisation to the Influenza Vaccination: a Randomised Controlled Trial of a Vaccination Model of Immune Response
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Immune Response
Keywords: Immune Response
Immune Function
Gut Health
Gut Microbiota
Snack
Lead sponsor: King's College London
Sponsor class: OTHER
First posted: 2022-08-25
Enrollment: 88
Sex: ALL
Minimum age (years): 40
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the impact of replacing usual snacks with alternative snack foods on the immune response to influenza vaccination in a population of healthy, middle-aged adults.

Detailed description: Nutrition plays an important role in the immune system by providing energy and metabolites to support the function of immune cells, allowing them to initiate effective immune responses. Diet is therefore a modifiable factor in impacting immune function and is currently a topic of substantial interest in health research. Snack consumption has been shown to account for approximately 20-30% of daily energy intake in adults. Therefore, snack choices have the potential to influence dietary intake and quality, and therefore immune function, both positively and negatively. This study assesses the effect of replacing usual snacks with alternative snack foods on the immune response in a model of viral infection - the seasonal influenza vaccine containing four prevalent influenza virus strains for the 2022/23 or 2023/24 influenza season, as determined by the World Health Organization.

This study is a parallel group, randomised controlled trial that will examine the replacement of usual snack foods with alternative snack foods on the immune response to seasonal influenza vaccination in humans, which will be assessed by measuring rates of seroconversion, and other immunological markers following vaccination. The intervention will be for 8 weeks, and influenza vaccination will be administered at 4-week midpoint. Participants will be followed up 3 months post-vaccination to assess incidence of upper respiratory symptoms.

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

Primary outcomes:
measure: Rates of seroconversion for ≥1 influenza virus strain
timeFrame: Week 8
Secondary outcomes:
measure: Rates of seroconversion for A/Wisconsin/588/2019 (H1N1)pdm09-like virus strain (strain 1a)
timeFrame: Week 8
measure: Rates of seroconversion for A/Wisconsin/67/2022 (H1N1)pdm09-like virus strain (strain 1b)
timeFrame: Week 8
measure: Rates of seroconversion for A/Darwin/6/2021 (H3N2)-like virus strain (strain 2)
timeFrame: Week 8
measure: Rates of seroconversion for influenza virus B/Austria/1359417/2021 (B/Victoria lineage)-like virus strain (strain 3)
timeFrame: Week 8
measure: Rates of seroconversion for B/Phuket/3073/2013 (B/Yamagata lineage)-like virus strain (strain 4)
timeFrame: Week 8
measure: Proportion of participants who do not achieve seroconversion for any influenza virus strain
timeFrame: Week 8
measure: Rates of seroconversion for only 1 influenza virus strain
timeFrame: Week 8
measure: Rates of seroconversion for 2 influenza virus strains
timeFrame: Week 8
measure: Rates of seroconversion for 3 influenza virus strains
timeFrame: Week 8
measure: Rates of seroconversion for 4 influenza virus strains
timeFrame: Week 8
measure: Geometric mean antigen-specific titres for or A/Wisconsin/588/2019 (H1N1)pdm09-like virus strain (strain 1a)
timeFrame: Week 0, 4 and 8
measure: Geometric mean antigen-specific titres for A/Wisconsin/67/2022 (H1N1)pdm09-like virus strain (strain 1b)
timeFrame: Week 0, 4 and 8
measure: Geometric mean antigen-specific titres for A/Darwin/6/2021 (H3N2)-like virus strain (strain 2)
timeFrame: Week 0, 4 and 8
measure: Geometric mean antigen-specific titres for B/Austria/1359417/2021 (B/Victoria lineage)-like virus strain (strain 3)
timeFrame: Week 0, 4 and 8
measure: Geometric mean antigen-specific titres for B/Phuket/3073/2013 (B/Yamagata lineage)-like virus strain (strain 4)
timeFrame: Week 0, 4 and 8
measure: Fold change in antigen-specific titres for A/Wisconsin/588/2019 (H1N1)pdm09-like virus strain (strain 1a)
timeFrame: Week 8
measure: Fold change in antigen-specific titres for A/Wisconsin/67/2022 (H1N1)pdm09-like virus strain (strain 1b)
timeFrame: Week 8
measure: Fold change in antigen-specific titres for A/Darwin/6/2021 (H3N2)-like virus strain (strain 2)
timeFrame: Week 8
measure: Fold change in antigen-specific titres for B/Austria/1359417/2021 (B/Victoria lineage)-like virus strain (strain 3)
timeFrame: Week 8
measure: Fold change in antigen-specific titres for B/Phuket/3073/2013 (B/Yamagata lineage)-like virus strain (strain 4)
timeFrame: Week 8
measure: Seroprotection for ≥1 influenza virus strain
timeFrame: Week 8
measure: Seroprotection for A/Wisconsin/588/2019 (H1N1)pdm09-like virus strain (strain 1a)
timeFrame: Week 8
measure: Seroprotection for A/Wisconsin/67/2022 (H1N1)pdm09-like virus strain (strain 1b)
timeFrame: Week 8
measure: Seroprotection for A/Darwin/6/2021 (H3N2)-like virus strain (strain 2)
timeFrame: Week 8
measure: Seroprotection for B/Austria/1359417/2021 (B/Victoria lineage)-like virus strain (strain 3)
timeFrame: Week 8
measure: Seroprotection for B/Phuket/3073/2013 (B/Yamagata lineage)-like virus strain (strain 4)
timeFrame: Week 8
measure: Proportion of participants who do not achieve seroprotection for any influenza virus strains
timeFrame: Week 8
measure: Seroprotection for 1 influenza virus strain
timeFrame: Week 8
measure: Seroprotection for 2 influenza virus strains
timeFrame: Week 8
measure: Seroprotection for 3 influenza virus strains
timeFrame: Week 8
measure: Seroprotection for 4 influenza virus strains
timeFrame: Week 8
measure: Markers of immunological function
timeFrame: Week 0, 4 and 8
measure: Incidence of upper respiratory symptoms
timeFrame: Week 4, 8, 12 and 16
measure: Faecal gut microbiota (composition, alpha- and beta-diversity)
timeFrame: Week 0, 4 and 8
measure: Faecal short-chain fatty acids (SCFA)
timeFrame: Week 0, 4 and 8
measure: Faecal water
timeFrame: Week 0, 4 and 8
measure: Gut symptoms
timeFrame: Week 0, 4 and 8
measure: Stool frequency
timeFrame: Week 0, 4 and 8
measure: Stool consistency
timeFrame: Week 0, 4 and 8
measure: Serum Vitamin E levels
timeFrame: Week 0, 4 and 8
measure: Serum Zinc levels
timeFrame: Week 0, 4 and 8
measure: Mental health status
timeFrame: Week 0, 4 and 8
measure: Dietary intake
timeFrame: Week 0, 4 and 8
measure: Physical activity
timeFrame: Week 0, 4 and 8
measure: Acceptability of snack products
timeFrame: Week 8
measure: Compliance
timeFrame: Week 8
measure: Adverse events
timeFrame: Week 0 - 8
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College London
Study officials:
References: