None listed
Conditions
Brief summary
Lifestyle risk factors such as lack of regular exercise, poor diet, ageing, excess body weight, high blood fats and high blood sugar levels can lead to narrowing and hardening of arteries, thus increasing our blood pressure. Long term elevated blood pressure can eventually increase our risk for developing cardiovascular diseases. Certain ingredients from food sources such as extracts from olive leaf, green coffee bean and beet may help lower blood pressure by enhancing the ability of blood vessels to dilate. These ingredients have independently been shown to have blood pressure lowering effects; however, their combined effects on blood pressure are unknown. In this study, we are looking to see if a novel formulation consisting of extracts from olive leaf, green coffee bean and beet can lower blood pressure in adults. We will also look at its effects on blood fats, blood sugar and insulin levels.
Interventions
After screening for study eligibility, a baseline blood sample for analysis of lipids, glucose and insulin sensitivity will be obtained. Participants will then be asked to wear an ambulatory blood pressure monitor for 24 hours and to keep an activity diary to enable blood pressure values to be related to activities.
Participants will return the monitor and activity diary the following day (24 hours after screening) and will be randomly allocated to take one tablet of the active formulation (10
After screening for study eligibility, a baseline blood sample for analysis of lipids, glucose and insulin sensitivity will be obtained. Participants will then be asked to wear an ambulatory blood pressure monitor for 24 hours and to keep an activity diary to enable blood pressure values to be related to activities. Participants will return the monitor and activity diary the following day (24 hours after screening) and will be randomly allocated to take one tablet of the active formulation (100mg of green coffee bean extract, 500mg of olive leaf extract, 150mg of beet powder) orally or a matching placebo in the morning and one table in the evening with main meals daily for 6 weeks. Participants will be required to write the time every time they consume a tablet in their supplement diary to serve as a reminder and to ensure compliance to study protocol. At the end of 6 weeks, they will return to have their blood sample taken and the ambulatory blood pressure monitor fitted. Participants will return 24 hours later to return the monitor and activity diary and to receive their alternate treatment for a further 6 weeks, after which they will return for the final assessments.
Sponsors
The University of Newcastle
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
Age 18 to 80 years Body mass index between 20 and 35kg/m2 (determined at screening/baseline visit) Systolic blood pressure (130-160mmHg) and/or diastolic blood pressure (85-100mmHg) (determined at screening/baseline visit) Unlikely to change medication and/or supplementation during the study
Exclusion criteria
A smoker or currently on nicotine therapy Currently in antihypertensive medication Currently on insulin therapy Pregnant or currently breastfeeding Unwilling to fast overnight before clinic visits Unwilling to wear the ambulatory blood pressure monitor and have their blood pressure monitored for 24 hours Unable to commit to the same time and day of the week for all 6 visits of the study Unwilling to donate 15mL of blood sample at week 0 (baseline) and at week 6 and week 12 after intervention commencement. Unwilling to maintain currently dietary and physical activity habits during the study. Any conditions or medication or dietary supplement that in the opinion of the principal investigator may confound the results of the study.
Outcome results
None listed