Snack Foods and Their Impact on the Immune Response Following Influenza Vaccination
NCT ID: NCT05515263
Last Updated: 2023-07-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
88 participants
INTERVENTIONAL
2022-09-09
2024-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Intervention snack
The intervention group will receive a snack food believed to be beneficial for immune function (high content of immunoregulatory nutrients).
Intervention snack
To be eaten in replacement of usual snacks twice a day for 8 weeks.
Control snack
The control group will receive an isocaloric, commercially available snack food (low content of immunoregulatory nutrients).
Control snack
To be eaten in replacement of usual snacks twice a day for 8 weeks.
Interventions
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Intervention snack
To be eaten in replacement of usual snacks twice a day for 8 weeks.
Control snack
To be eaten in replacement of usual snacks twice a day for 8 weeks.
Eligibility Criteria
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Inclusion Criteria
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
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
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
40 Years
64 Years
ALL
Yes
Sponsors
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King's College London
OTHER
Responsible Party
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Locations
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King's College London
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HR/DP-21/22-33040
Identifier Type: -
Identifier Source: org_study_id
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