Effect of a formulation containing blackcurrant powder, L-theanine and pine bark extract on immune responses to influenza vaccine in older healthy adults

Not Applicable

Recruiting

• Conditions: Immune response to influenza vaccine; Older age; Infection - Other infectious diseases; Inflammatory and Immune System - Normal development and function of the immune system

• Registration Number: ACTRN12621001561875
• Lead Sponsor: The New Zealand Institute for Plant and Food Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-11-17
• Last Update Posted: 24 October 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 120

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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Specific T-cell subset proliferation of ex-vivo stimulated peripheral immune cells isolated from participants peripheral blood with influenza antigens.[0, 6, 8 (primary timepoint) and 12 weeks post initiation of intervention.];Cytokine production of ex-vivo stimulated peripheral immune cells isolated from participants peripheral blood with influenza antigens.[0, 6, 8 (primary timepoint) and 12 weeks post initiation of intervention.]