None listed
Conditions
Brief summary
The purpose of this study is to investigate the effect a blackcurrant powder formulation on immune responses to the influenza vaccine. This is multi-centre randomised double blind placebo controlled parallel intervention study which aims to recruit 120 healthy older adults (50+ years). This means the recruited participants will consume either the blackcurrant based formulation or a placebo for 12 weeks and the participants and trial co-ordinators will not know what treatment is being given. There will be five trial days, including the 4 week visit to receive the influenza vaccine. Fasted blood samples with be collected at 0, 6, 8 and 12 weeks for assays, which will test the participants immune responses towards the influenza antigen. The primary aim of the study is to determine whether the blackcurrant formulation enhances immune responses toward influenza antigens.
Interventions
Freeze-dried blackcurrants (with a minimum serve of 3.2 mg/kg anthocyanin) with 150 mg L-theanine and 150 mg pine bark extract added. The formulations will be a powder which will be mixed with 250 ml water and will be given daily for 12 weeks. Participants will be asked to fill out a short daily health questionnaire during the intervention period asking if the intervention has been consumed, which will serve as a reminder to take their intervention. In addition a weekly SMS/E-mail reminder will
Freeze-dried blackcurrants (with a minimum serve of 3.2 mg/kg anthocyanin) with 150 mg L-theanine and 150 mg pine bark extract added. The formulations will be a powder which will be mixed with 250 ml water and will be given daily for 12 weeks. Participants will be asked to fill out a short daily health questionnaire during the intervention period asking if the intervention has been consumed, which will serve as a reminder to take their intervention. In addition a weekly SMS/E-mail reminder will be sent. A one-week wash-out period will precede the intervention stage, where participants will be asked to avoid high-polyphenolic contain foods, such as excessive caffeine or chocolate. A SMS/E-mail reminder will be sent and a 3-day diet record will be taken during this week to assess baseline diet. After 4 weeks of intervention participants will be vaccinated with the influenza vaccine developed according to World Health Organisation (WHO) guidelines for 2022 and approved by Medsafe, New Zealand. Vaccines will be administered intramuscularly in the deltoid region of the arm by a qualified nurse (Life Care Consultants, New Zealand) as part of this study.
Sponsors
The New Zealand Institute for Plant and Food Research
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Age: Aged over 50 years Sex: Any gender Body weight <120Kg Health: Healthy as gauged by self-assessment and result on the General Health Questionnaire. Blood parameters which do not indicate clinically significant illness for albumin, alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea, calcium, chloride, creatinine, potassium, sodium, total bilirubin, total protein, glucose and HBA1c. . Agreement: Participant having given written informed consent to comply with the conditions of the trial. No allergies to ingredients contained in the active or placebo treatment or the influenza vaccine, such as blackcurrant or egg products. No previous severe reaction to the influenza vaccine Did not receive the influenza vaccine in 2021 and are willing to have the influenza vaccine as part of this study.
Exclusion criteria
Blood parameters for albumin, alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea, calcium, chloride, creatinine, potassium, sodium, total bilirubin, total protein, glucose and HBA1c being indicative of clinically significant illness. Non-fasting: Having consumed anything apart from water in the twelve hours prior to blood tests. Allergic or intolerant blackcurrant or other ingredients containing in the active or placebo treatments or egg products (potentially in the influenza vaccine). Had a previous severe reaction to the influenza vaccine. Had the influenza vaccine in 2021. Pregnant or breastfeeding or planning to get pregnant in the near future. Long term chronic illnesses requiring treatment, such as cancer and cardiovascular disease. Participants will be excluded if they are unwilling or unable to provide informed consent or comply with the study procedures. Participants that have Type I or II diabetes (ii) blood borne diseases (e.g. hepatitis), (iii) clinically diagnosed high/low blood pressure, (iv) are taking medication that affects the properties of blood (e.g. blood clotting).
Outcome results
None listed