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

  • STATUS
    Recruiting
  • End date
    Oct 15, 2023
  • participants needed
    88
  • sponsor
    King's College London
Updated on 7 October 2022
Accepts healthy volunteers

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.

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 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.

Details
Condition Immune Response
Treatment Control snack, Intervention snack
Clinical Study IdentifierNCT05515263
SponsorKing's College London
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
Already vaccinated with any influenza vaccine licensed for the 2022/2023 season
Received any influenza vaccination within six months prior to the start of the study
Received any other vaccinations within one month prior to the start of the study (except for COVID-19 vaccination)
Women who are pregnant, lactating or planning pregnancy
Ongoing alcohol, drug or medication abuse
Unexplained or unintentional weight loss in the past six months
Clear my responses

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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