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

NCT05515263 | Unknown

• 1 other identifier: HR/DP-21/22-33040
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Immune Response

Keywords

Immune Response; Immune Function; Gut Health; Gut Microbiota; Snack

Outcome Measures

Primary Outcomes (1)

• Rates of seroconversion for ≥1 influenza virus strain

  The proportion of participants achieving seroconversion (≥4-fold increase in specific antibody titre) in at least one influenza virus strain. Titres will be assessed using the Hemagglutination Inhibition Assay (HAI) and fold change will be calculated.

  Week 8

Secondary Outcomes (47)

• Rates of seroconversion for A/Wisconsin/588/2019 (H1N1)pdm09-like virus strain (strain 1a)

  Week 8

• Rates of seroconversion for A/Wisconsin/67/2022 (H1N1)pdm09-like virus strain (strain 1b)

  Week 8

• Rates of seroconversion for A/Darwin/6/2021 (H3N2)-like virus strain (strain 2)

  Week 8

• Rates of seroconversion for influenza virus B/Austria/1359417/2021 (B/Victoria lineage)-like virus strain (strain 3)

  Week 8

• Rates of seroconversion for B/Phuket/3073/2013 (B/Yamagata lineage)-like virus strain (strain 4)

  Week 8

Study Arms (2)

Intervention snack

EXPERIMENTAL

The intervention group will receive a snack food believed to be beneficial for immune function (high content of immunoregulatory nutrients).

Dietary Supplement: Intervention snack

Control snack

PLACEBO COMPARATOR

The control group will receive an isocaloric, commercially available snack food (low content of immunoregulatory nutrients).

Dietary Supplement: Control snack

Interventions

Intervention snack DIETARY_SUPPLEMENT

To be eaten in replacement of usual snacks twice a day for 8 weeks.

Intervention snack

Control snack DIETARY_SUPPLEMENT

To be eaten in replacement of usual snacks twice a day for 8 weeks.

Control snack

Eligibility Criteria

• Age: 40 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men or women, aged between 40-64 years
• Body mass index (BMI) of 18.50 - 29.99 kg/m2
• Individuals who regularly consume snacks (≥2 per day, excluding fruit, vegetable, nut and seed snacks)
• Fibre intake \<30 g/d
• 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
• Willing to avoid receiving any COVID-19 vaccination/booster between week 2 and week 8 of the intervention period
• Willing to discontinue use of prebiotics and probiotics during the trial
• Willing to follow the protocol and provide consent

You may not qualify if:

• Allergy or intolerance to any intervention products
• Dislike of any intervention products
• 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).
• 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.
• Ongoing use of antiviral agents, or any other drugs known to impact study outcome measures
• Use of immunoglobulins and/or any blood products within the three months prior to vaccination
• Ongoing use of anticoagulants (e.g., warfarin)
• Antibiotic treatment in the month prior to the start of the study
• Consumption of probiotics or prebiotic products within the four weeks prior to the start of the study
• History of severe adverse reaction and/or allergic reaction associated with the influenza vaccine or any other vaccine
• 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
• Suffered from influenza illness in the six months prior to the start of the study

Sponsors & Collaborators

• King's College London: lead

Study Sites (1)

King's College London

London, SE1 9NH, United Kingdom

RECRUITING

Central Study Contacts

Alice van der Schoot, MSc

CONTACT

020 7848 4552; nutrimmune@kcl.ac.uk

Eirini Dimidi, MSc, PhD

CONTACT

020 7848 4552; nutrimmune@kcl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2022
• First Posted: August 25, 2022
• Study Start: September 9, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)