Immune ResponseNutrImmuneNCT05515263
Snack Foods and Their Impact on the Immune Response Following Influenza Vaccination
A study testing Intervention snack in people with Immune Response, run by King's College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Immune Response
- What is being tested?
- Intervention snack
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Sep 2022to Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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).
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- 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
- 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
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
King's College London
London, SE1 9NH
Alice van der Schoot, MSc, 020 7848 4552, nutrimmune@kcl.ac.uk
About this study
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
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.
Read the 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.
- Conditions
- Immune Response
- Being tested
- Intervention snack, Control snack
- Keywords
- Immune Response, Immune Function, Gut Health, Gut Microbiota, Snack
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention snackDietary supplement
To be eaten in replacement of usual snacks twice a day for 8 weeks.
Control snackDietary supplement
To be eaten in replacement of usual snacks twice a day for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intervention snack | Experimental | The intervention group will receive a snack food believed to be beneficial for immune function (high content of immunoregulatory nutrients). Receives: Dietary Supplement: Intervention snack |
| Control snack | Placebo comparator | The control group will receive an isocaloric, commercially available snack food (low content of immunoregulatory nutrients). Receives: Dietary Supplement: Control snack |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 8
Secondary outcomes (47)
Rates of seroconversion for A/Wisconsin/588/2019 (H1N1)pdm09-like virus strain (strain 1a)
The proportion of participants achieving seroconversion for A/Wisconsin/588/2019 (H1N1)pdm09-like virus strain. Titres will be assessed by HAI and fold change will be calculated.
Measured: Week 8
Rates of seroconversion for A/Wisconsin/67/2022 (H1N1)pdm09-like virus strain (strain 1b)
The proportion of participants achieving seroconversion for A A/Wisconsin/67/2022 (H1N1)pdm09-like virus strain. Titres will be assessed by HAI and fold change will be calculated.
Measured: Week 8
Rates of seroconversion for A/Darwin/6/2021 (H3N2)-like virus strain (strain 2)
The proportion of participants achieving seroconversion for A/Darwin/6/2021 (H3N2)-like virus strain. Titres will be assessed by HAI and fold change will be calculated.
Measured: Week 8
Rates of seroconversion for influenza virus B/Austria/1359417/2021 (B/Victoria lineage)-like virus strain (strain 3)
The proportion of participants achieving seroconversion for B/Austria/1359417/2021 (B/Victoria lineage)-like virus strain. Titres will be assessed by HAI and fold change will be calculated.
Measured: Week 8
Rates of seroconversion for B/Phuket/3073/2013 (B/Yamagata lineage)-like virus strain (strain 4)
The proportion of participants achieving seroconversion for B/Phuket/3073/2013 (B/Yamagata lineage)-like virus strain. Titres will be assessed by HAI and fold change will be calculated.
Measured: Week 8
Proportion of participants who do not achieve seroconversion for any influenza virus strain
Titres will be assessed by HAI and fold change will be calculated.
Measured: Week 8
Rates of seroconversion for only 1 influenza virus strain
The proportion of participants achieving seroconversion for 1 influenza virus strain. Titres will be assessed by HAI and fold change will be calculated.
Measured: Week 8
Rates of seroconversion for 2 influenza virus strains
The proportion of participants achieving seroconversion for 2 influenza virus strains. Titres will be assessed by HAI and fold change will be calculated.
Measured: Week 8
Rates of seroconversion for 3 influenza virus strains
The proportion of participants achieving seroconversion for 3 influenza virus strains. Titres will be assessed by HAI and fold change will be calculated.
Measured: Week 8
Rates of seroconversion for 4 influenza virus strains
The proportion of participants achieving seroconversion for all 4 influenza virus strains. Titres will be assessed by HAI and fold change will be calculated.
Measured: Week 8
Geometric mean antigen-specific titres for or A/Wisconsin/588/2019 (H1N1)pdm09-like virus strain (strain 1a)
Titres will be assessed by HAI.
Measured: Week 0, 4 and 8
Geometric mean antigen-specific titres for A/Wisconsin/67/2022 (H1N1)pdm09-like virus strain (strain 1b)
Titres will be assessed by HAI.
Measured: Week 0, 4 and 8
Geometric mean antigen-specific titres for A/Darwin/6/2021 (H3N2)-like virus strain (strain 2)
Titres will be assessed by HAI.
Measured: Week 0, 4 and 8
Geometric mean antigen-specific titres for B/Austria/1359417/2021 (B/Victoria lineage)-like virus strain (strain 3)
Titres will be assessed by HAI.
Measured: Week 0, 4 and 8
Geometric mean antigen-specific titres for B/Phuket/3073/2013 (B/Yamagata lineage)-like virus strain (strain 4)
Titres will be assessed by HAI assay.
Measured: Week 0, 4 and 8
Fold change in antigen-specific titres for A/Wisconsin/588/2019 (H1N1)pdm09-like virus strain (strain 1a)
Titres will be assessed by HAI and fold change will be calculated.
Measured: Week 8
Fold change in antigen-specific titres for A/Wisconsin/67/2022 (H1N1)pdm09-like virus strain (strain 1b)
Titres will be assessed by HAI and fold change will be calculated.
Measured: Week 8
Fold change in antigen-specific titres for A/Darwin/6/2021 (H3N2)-like virus strain (strain 2)
Titres will be assessed by HAI and fold change will be calculated.
Measured: Week 8
Fold change in antigen-specific titres for B/Austria/1359417/2021 (B/Victoria lineage)-like virus strain (strain 3)
Titres will be assessed by HAI and fold change will be calculated.
Measured: Week 8
Fold change in antigen-specific titres for B/Phuket/3073/2013 (B/Yamagata lineage)-like virus strain (strain 4)
Titres will be assessed by HAI and fold change will be calculated.
Measured: Week 8
Seroprotection for ≥1 influenza virus strain
The proportion of participants achieving seroprotection (HAI titre of ≥1:40) in at least one of the four influenza virus strains.
Measured: Week 8
Seroprotection for A/Wisconsin/588/2019 (H1N1)pdm09-like virus strain (strain 1a)
The proportion of participants achieving seroprotection (HAI titre of ≥1:40) for A/Wisconsin/588/2019 (H1N1)pdm09-like virus strain.
Measured: Week 8
Seroprotection for A/Wisconsin/67/2022 (H1N1)pdm09-like virus strain (strain 1b)
The proportion of participants achieving seroprotection (HAI titre of ≥1:40) for A/Wisconsin/67/2022 (H1N1)pdm09-like virus strain.
Measured: Week 8
Seroprotection for A/Darwin/6/2021 (H3N2)-like virus strain (strain 2)
The proportion of participants achieving seroprotection (HAI titre of ≥1:40) for A/Darwin/6/2021 (H3N2)-like virus strain.
Measured: Week 8
Seroprotection for B/Austria/1359417/2021 (B/Victoria lineage)-like virus strain (strain 3)
The proportion of participants achieving seroprotection (HAI titre of ≥1:40) for B/Austria/1359417/2021 (B/Victoria lineage)-like virus strain.
Measured: Week 8
Seroprotection for B/Phuket/3073/2013 (B/Yamagata lineage)-like virus strain (strain 4)
The proportion of participants achieving seroprotection (HAI titre of ≥1:40) for B/Phuket/3073/2013 (B/Yamagata lineage)-like virus strain.
Measured: Week 8
Proportion of participants who do not achieve seroprotection for any influenza virus strains
Seroprotection is defined as HAI titre of ≥1:40
Measured: Week 8
Seroprotection for 1 influenza virus strain
The proportion of participants achieving seroprotection (HAI titre of ≥1:40) for 1 influenza virus strain.
Measured: Week 8
Seroprotection for 2 influenza virus strains
The proportion of participants achieving seroprotection (HAI titre of ≥1:40) for 2 influenza virus strains.
Measured: Week 8
Seroprotection for 3 influenza virus strains
The proportion of participants achieving seroprotection (HAI titre of ≥1:40) for 3 influenza virus strains.
Measured: Week 8
Seroprotection for 4 influenza virus strains
The proportion of participants achieving seroprotection (HAI titre of ≥1:40) for all 4 influenza virus strains.
Measured: Week 8
Markers of immunological function
Isolation of peripheral blood mononuclear cells (PBMCs) to assess markers of immunological function.
Measured: Week 0, 4 and 8
Incidence of upper respiratory symptoms
Measured using the Wisconsin Upper Respiratory Symptom Survey (WURSS-24).
Measured: Week 4, 8, 12 and 16
Faecal gut microbiota (composition, alpha- and beta-diversity)
Measured by 16S community profiling (Illumina Miseq) of bacterial genomic DNA isolated from stool samples.
Measured: Week 0, 4 and 8
Faecal short-chain fatty acids (SCFA)
Measured by gas liquid chromatography of stool samples.
Measured: Week 0, 4 and 8
Faecal water
Determined from stool samples by oven-drying.
Measured: Week 0, 4 and 8
Gut symptoms
Measured using the Gastrointestinal Symptom Rating Scale (GSRS) (7-day diary; questionnaire).
Measured: Week 0, 4 and 8
Stool frequency
Measured using self-reported number bowel movements daily recorded in a 7-day diary.
Measured: Week 0, 4 and 8
Stool consistency
Measured using the Bristol stool form scale (7-day dairy; questionnaire).
Measured: Week 0, 4 and 8
Serum Vitamin E levels
Measured in blood sample - analysis of serum vitamin E levels by Liquid chromatography-mass spectrometry.
Measured: Week 0, 4 and 8
Serum Zinc levels
Measured in blood sample - analysis of serum zinc levels by automated assay.
Measured: Week 0, 4 and 8
Mental health status
Measured using The Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS). Scores range from 0-48 with higher scores indicating more severe depression/anxiety.
Measured: Week 0, 4 and 8
Dietary intake
7-day food and drink diary.
Measured: Week 0, 4 and 8
Physical activity
Measured using the International Physical Activity Questionnaire (IPAQ).
Measured: Week 0, 4 and 8
Acceptability of snack products
Measured using an Acceptability of dietary intervention questionnaire developed by King's College London for use in dietary intervention studies. The questionnaire assesses acceptability using a number of domains including flavour, texture, portion size.
Measured: Week 8
Compliance
Return of unused snacks at the final visit (consumption of >75% of total snacks will be considered compliant).
Measured: Week 8
Adverse events
Interview-administered questionnaire.
Measured: Week 0 - 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start9 Sep 2022
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Immune ResponseStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05515263
- Sponsor's protocol ID
- HR/DP-21/22-33040
- Acronym
- NutrImmune
- Status last verified
- Jul 2023
- First submitted
- 17 Aug 2022
- Last updated
- 27 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
van der Schoot A, Creedon AC, Argomaniz N, Bajka B, Hall WL, Farsi DN, Chrysostomou D, Marchesi JR, Perucha E, Turcanu V, Whelan K, Dimidi E. Almonds and the optimization of immune responses to influenza vaccination, compared to a control snack, in healthy adults: a randomized controlled trial. Am J Clin Nutr. 2026 Oct 26:101596. doi: 10.1016/j.ajcnut.2026.101596. Online ahead of print.
PubMed 42933536
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05515263
- Acronym / sponsor ID
- NutrImmune / HR/DP-21/22-33040
- Conditions
- Immune Response
- Keywords
- Immune Response, Immune Function, Gut Health, Gut Microbiota, Snack
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 9 Sep 2022 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 25 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention snack | Experimental | Dietary Supplement: Intervention snackThe intervention group will receive a snack food believed to be beneficial for immune function (high content of immunoregulatory nutrients). |
| Control snack | Placebo comparator | Dietary Supplement: Control snackThe control group will receive an isocaloric, commercially available snack food (low content of immunoregulatory nutrients). |
Who may qualify
- Ages
- 40 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (21 listed)
- Allergy or intolerance to any intervention products
- Dislike of any intervention products
- Immunodeficiency/immunosuppression due to disease or medication, such as:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention snackTo be eaten in replacement of usual snacks twice a day for 8 weeks. | Dietary supplement | Intervention snack |
| Control snackTo be eaten in replacement of usual snacks twice a day for 8 weeks. | Dietary supplement | Control snack |
Primary outcome
Rates of seroconversion for ≥1 influenza virus strain
Time frame: Week 8
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.
47 secondary outcomes
Rates of seroconversion for A/Wisconsin/588/2019 (H1N1)pdm09-like virus strain (strain 1a)
Time frame: Week 8
Rates of seroconversion for A/Wisconsin/67/2022 (H1N1)pdm09-like virus strain (strain 1b)
Time frame: Week 8
Rates of seroconversion for A/Darwin/6/2021 (H3N2)-like virus strain (strain 2)
Time frame: Week 8
Rates of seroconversion for influenza virus B/Austria/1359417/2021 (B/Victoria lineage)-like virus strain (strain 3)
Time frame: Week 8
Rates of seroconversion for B/Phuket/3073/2013 (B/Yamagata lineage)-like virus strain (strain 4)
Time frame: Week 8
Proportion of participants who do not achieve seroconversion for any influenza virus strain
Time frame: Week 8
Rates of seroconversion for only 1 influenza virus strain
Time frame: Week 8
Rates of seroconversion for 2 influenza virus strains
Time frame: Week 8
Rates of seroconversion for 3 influenza virus strains
Time frame: Week 8
Rates of seroconversion for 4 influenza virus strains
Time frame: Week 8
Geometric mean antigen-specific titres for or A/Wisconsin/588/2019 (H1N1)pdm09-like virus strain (strain 1a)
Time frame: Week 0, 4 and 8
Geometric mean antigen-specific titres for A/Wisconsin/67/2022 (H1N1)pdm09-like virus strain (strain 1b)
Time frame: Week 0, 4 and 8
Geometric mean antigen-specific titres for A/Darwin/6/2021 (H3N2)-like virus strain (strain 2)
Time frame: Week 0, 4 and 8
Geometric mean antigen-specific titres for B/Austria/1359417/2021 (B/Victoria lineage)-like virus strain (strain 3)
Time frame: Week 0, 4 and 8
Geometric mean antigen-specific titres for B/Phuket/3073/2013 (B/Yamagata lineage)-like virus strain (strain 4)
Time frame: Week 0, 4 and 8
Fold change in antigen-specific titres for A/Wisconsin/588/2019 (H1N1)pdm09-like virus strain (strain 1a)
Time frame: Week 8
Fold change in antigen-specific titres for A/Wisconsin/67/2022 (H1N1)pdm09-like virus strain (strain 1b)
Time frame: Week 8
Fold change in antigen-specific titres for A/Darwin/6/2021 (H3N2)-like virus strain (strain 2)
Time frame: Week 8
Fold change in antigen-specific titres for B/Austria/1359417/2021 (B/Victoria lineage)-like virus strain (strain 3)
Time frame: Week 8
Fold change in antigen-specific titres for B/Phuket/3073/2013 (B/Yamagata lineage)-like virus strain (strain 4)
Time frame: Week 8
Seroprotection for ≥1 influenza virus strain
Time frame: Week 8
Seroprotection for A/Wisconsin/588/2019 (H1N1)pdm09-like virus strain (strain 1a)
Time frame: Week 8
Seroprotection for A/Wisconsin/67/2022 (H1N1)pdm09-like virus strain (strain 1b)
Time frame: Week 8
Seroprotection for A/Darwin/6/2021 (H3N2)-like virus strain (strain 2)
Time frame: Week 8
Seroprotection for B/Austria/1359417/2021 (B/Victoria lineage)-like virus strain (strain 3)
Time frame: Week 8
Seroprotection for B/Phuket/3073/2013 (B/Yamagata lineage)-like virus strain (strain 4)
Time frame: Week 8
Proportion of participants who do not achieve seroprotection for any influenza virus strains
Time frame: Week 8
Seroprotection for 1 influenza virus strain
Time frame: Week 8
Seroprotection for 2 influenza virus strains
Time frame: Week 8
Seroprotection for 3 influenza virus strains
Time frame: Week 8
Seroprotection for 4 influenza virus strains
Time frame: Week 8
Markers of immunological function
Time frame: Week 0, 4 and 8
Incidence of upper respiratory symptoms
Time frame: Week 4, 8, 12 and 16
Faecal gut microbiota (composition, alpha- and beta-diversity)
Time frame: Week 0, 4 and 8
Faecal short-chain fatty acids (SCFA)
Time frame: Week 0, 4 and 8
Faecal water
Time frame: Week 0, 4 and 8
Gut symptoms
Time frame: Week 0, 4 and 8
Stool frequency
Time frame: Week 0, 4 and 8
Stool consistency
Time frame: Week 0, 4 and 8
Serum Vitamin E levels
Time frame: Week 0, 4 and 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Derived from this study: PubMed 42933536van der Schoot A, Creedon AC, Argomaniz N, Bajka B, Hall WL, Farsi DN, Chrysostomou D, Marchesi JR, Perucha E, Turcanu V, Whelan K, Dimidi E. Almonds and the optimization of immune responses to influenza vaccination, compared to a control snack, in healthy adults: a randomized controlled trial. Am J Clin Nutr. 2026 Oct 26:101596. doi: 10.1016/j.ajcnut.2026.101596. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention snack in people with Immune Response, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alice van der Schoot, MSc (020 7848 4552, nutrimmune@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of seroconversion for ≥1 influenza virus strain (time frame: Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05515263, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.