None listed
Conditions
Brief summary
The study is designed to look at the effect of supplementation with low dose mixed vitamin E and sesame, either alone on in combination on blood pressure in people who already have elevated blood pressure. The study will be double-blinded with both the study co-ordinator and participants blinded to the tocopherol treatment. However, because of a noticeable taste difference between the placebo spread and the sesame spread, this will not be able to be blinded
Interventions
The study is a randomised, double-blind, placebo controlled trial with a 6 week intervention period. Treatment arms are:
1. 50mg mixed tocopherol supplement + 10g placebo spread
2. Placebo supplement + 10g sesame spread
3. 50mg mixed tocopherol supplement + 10g sesame spread
Capsules will be taken once in the morning and once in the evening as 25mg capsules. 5g of spread will consumed once in the morning and in the evening along with the capsules.
Sponsors
University of Western Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Hypertensive, either treated or untreated with a systolic blood pressure between 100-160 mmHg and a distolic blood pressure <100 mmHg (mean of 3 readings taken every 2 mins).
Exclusion criteria
1. Diabetes requiring medication2. Recent coronary/cerebrovascular event <6 months, or heart failure3. Bdy mass index >354. Use of pure vitamin E supplements5. Use of oral contraceptives or premenopausal6. Evidence of renal impairment7. Smoking8. Alcohol intake >40g/day men or 30g/day women9. Episodic use of non-steroidal anti-inflammatory medication.
Outcome results
None listed