Effect of a formulation containing blackcurrant powder, L-theanine and pine bark extract on immune responses to influenza vaccine in older healthy adultsA multi-centred, randomised, double blind, placebo controlled, parallel study

The New Zealand Institute for Plant and Food Research0 个研究点目标入组 120 人开始时间: 2021年11月17日最近更新: 2022年10月24日

适应症

试验速览

暂无简介。

•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.

•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).

发起方

The New Zealand Institute for Plant and Food Research