NCT05515263招募中不适用
Snack Foods and Their Impact on Immune Optimisation to the Influenza Vaccination: a Randomised Controlled Trial of a Vaccination Model of Immune Response
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Rates of seroconversion for ≥1 influenza virus strain
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
- •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
结局指标
主要结局
Rates of seroconversion for ≥1 influenza virus strain
时间窗: 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.
次要结局
- Serum Zinc levels(Week 0, 4 and 8)
- Rates of seroconversion for influenza virus B/Austria/1359417/2021 (B/Victoria lineage)-like virus strain (strain 3)(Week 8)
- Geometric mean antigen-specific titres for A/Darwin/6/2021 (H3N2)-like virus strain (strain 2)(Week 0, 4 and 8)
- Rates of seroconversion for A/Darwin/6/2021 (H3N2)-like virus strain (strain 2)(Week 8)
- Rates of seroconversion for B/Phuket/3073/2013 (B/Yamagata lineage)-like virus strain (strain 4)(Week 8)
- Rates of seroconversion for 2 influenza virus strains(Week 8)
- Rates of seroconversion for 3 influenza virus strains(Week 8)
- Geometric mean antigen-specific titres for or A/Wisconsin/588/2019 (H1N1)pdm09-like virus strain (strain 1a)(Week 0, 4 and 8)
- Rates of seroconversion for A/Wisconsin/67/2022 (H1N1)pdm09-like virus strain (strain 1b)(Week 8)
- Seroprotection for B/Austria/1359417/2021 (B/Victoria lineage)-like virus strain (strain 3)(Week 8)
- Rates of seroconversion for A/Wisconsin/588/2019 (H1N1)pdm09-like virus strain (strain 1a)(Week 8)
- Rates of seroconversion for only 1 influenza virus strain(Week 8)
- Geometric mean antigen-specific titres for B/Phuket/3073/2013 (B/Yamagata lineage)-like virus strain (strain 4)(Week 0, 4 and 8)
- Fold change in antigen-specific titres for A/Wisconsin/588/2019 (H1N1)pdm09-like virus strain (strain 1a)(Week 8)
- Seroprotection for A/Wisconsin/67/2022 (H1N1)pdm09-like virus strain (strain 1b)(Week 8)
- Seroprotection for B/Phuket/3073/2013 (B/Yamagata lineage)-like virus strain (strain 4)(Week 8)
- Proportion of participants who do not achieve seroprotection for any influenza virus strains(Week 8)
- Markers of immunological function(Week 0, 4 and 8)
- Incidence of upper respiratory symptoms(Week 4, 8, 12 and 16)
- Proportion of participants who do not achieve seroconversion for any influenza virus strain(Week 8)
- Seroprotection for A/Darwin/6/2021 (H3N2)-like virus strain (strain 2)(Week 8)
- Seroprotection for 1 influenza virus strain(Week 8)
- Faecal gut microbiota (composition, alpha- and beta-diversity)(Week 0, 4 and 8)
- Faecal short-chain fatty acids (SCFA)(Week 0, 4 and 8)
- Rates of seroconversion for 4 influenza virus strains(Week 8)
- Geometric mean antigen-specific titres for A/Wisconsin/67/2022 (H1N1)pdm09-like virus strain (strain 1b)(Week 0, 4 and 8)
- Fold change in antigen-specific titres for A/Wisconsin/67/2022 (H1N1)pdm09-like virus strain (strain 1b)(Week 8)
- Fold change in antigen-specific titres for A/Darwin/6/2021 (H3N2)-like virus strain (strain 2)(Week 8)
- Fold change in antigen-specific titres for B/Phuket/3073/2013 (B/Yamagata lineage)-like virus strain (strain 4)(Week 8)
- Seroprotection for ≥1 influenza virus strain(Week 8)
- Seroprotection for A/Wisconsin/588/2019 (H1N1)pdm09-like virus strain (strain 1a)(Week 8)
- Gut symptoms(Week 0, 4 and 8)
- Stool frequency(Week 0, 4 and 8)
- Geometric mean antigen-specific titres for B/Austria/1359417/2021 (B/Victoria lineage)-like virus strain (strain 3)(Week 0, 4 and 8)
- Fold change in antigen-specific titres for B/Austria/1359417/2021 (B/Victoria lineage)-like virus strain (strain 3)(Week 8)
- Serum Vitamin E levels(Week 0, 4 and 8)
- Seroprotection for 2 influenza virus strains(Week 8)
- Seroprotection for 3 influenza virus strains(Week 8)
- Seroprotection for 4 influenza virus strains(Week 8)
- Faecal water(Week 0, 4 and 8)
- Dietary intake(Week 0, 4 and 8)
- Physical activity(Week 0, 4 and 8)
- Stool consistency(Week 0, 4 and 8)
- Acceptability of snack products(Week 8)
- Mental health status(Week 0, 4 and 8)
- Compliance(Week 8)
- Adverse events(Week 0 - 8)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Snack Foods and Their Impact on Gastrointestinal Microbiology, Function and SymptomsHuman MicrobiomeEating BehaviorNCT03581812King's College London87
尚未招募
Unknown
Effects of test food intake on immune indicators and subjective symptoms related to physical condition changes in healthy individuals. -A randomized, placebo-controlled, double-blind, parallel-group comparison studyHealthy adultsJPRN-UMIN000053429KSO Corporation140
尚未招募
Unknown
The effects of test food intake on immune functioHealthy adultsJPRN-UMIN000050586Miura Clinic, Medical Corporation Kanonkai20
尚未招募
Unknown
The effects of test food intake on immune functioHealthy adultsJPRN-UMIN000053006Miura Clinic, Medical Corporation Kanonkai150
尚未招募
不适用
The effects of test food intake on immune function: Placebo-controlled, double-blind, randomized, pararellel-group comparison study-2JPRN-UMIN000042467Miura Clinic, Medical Corporation Kanonkai60