Skip to content

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

Immune modulation mechanisms in healthy human volunteers following influenza vaccination and daily supplementation palm tocotrienol-rich fraction

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622000844741
Enrollment
150
Registered
2022-06-15
Start date
2022-09-01
Completion date
2022-12-31
Last updated
2022-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Having a healthy immune system is very crucial so that our body is prepared to fight infections at any time. Healthy volunteers will be asked to take soft gels containing palm vitamin E or placebo for 56 days and they will receive a single shot of flu vaccine on day 28. The study aims to show that daily supplementation of palm vitamin E can boost host immune system so that we may be able to fight infectious agents better and have a better quality of life.

Interventions

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

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

Sponsors

Monash University Malaysia
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Exclusion criteria

Have some health-related problems (e.g. flu, fever, allergy) Organ failures Obese Pregnant (females) Breast-feeding (females)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 9, 2026