Evaluating the vitamin E from palm oil on immune response to flu vaccine

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2022
INTERVENTION: Healthy volunteers will be randomly assigned to one of five study groups i.e. daily oral supplementation with tocotrienol‐rich fraction (TRF) sofgels [50 mg, 100 mg, 200 mg or 400 mg] for 8 weeks. All subjects will receive a single intramuscular injection of flu vaccine in their arm at the end of week 4 (Day 28) and will continue with the same supplementation for another 4 weeks. The flu vaccine that we plan to use for this study is the Vaxigrip Tetra Influenza Vaccine Types A &B All subjects will be asked to bring along the bottles with the supplements as a way of monitoring compliance CONDITION: Immune response to influenza vaccine healthy volunteers; ; Immune response to influenza vaccine healthy volunteers Inflammatory and Immune System ‐ Normal development and function of the immune system PRIMARY OUTCOME: Immune response to the influenza vaccine by quantifying antibodies to influenza vaccine in blood samples using ELISA with or without supplementation with tocotrienol‐rich fraction (TRF)[This primary outcome will only be determined with samples taken on day 56 post‐intervention] SECONDARY OUTCOME: Plasma levels of vitamin E[This will be determined with plasma samples taken on day 56 post‐intervention using high‐performance liquid chromatography (HPLC)] INCLUSION CRITERIA: 18‐60 years‐old Healthy and free of diseases (biochemical tests) Do not have any chronic conditions (e.g. metabolic diseases, diabetes, cancer) Not on any long‐term treatment/medication Not taken any vitamin E supplements for the past 3‐months (low plasma vitamin E) Non‐smoker Not received any flu vaccination in the last 12‐months (low antibody to influenza vaccine) Normal to overweight bodyweight
Epistemonikos ID: 9c22e599c595577febe24e427955361ba2bcf9ee
First added on: Aug 25, 2024