We are looking for people aged 18 to 65 in Adelaide to participate in a study investigating the effectiveness of nutritional supplementation in adults with mild hypercholesterolaemia. The aim of the study is to research ways to lower cholesterol without medication.
This study is taking place in Adelaide
To participate you must be able to attend two visits at our clinic based in Adelaide's CBD.
Cardiovascular disease (CVD) remains the leading cause of mortality worldwide, accounting for approximately one third of all deaths globally. Reducing serum low-density lipoprotein (LDL)-cholesterol is the primary therapeutic target for reducing CVD risk. Plant sterols, bergamot juice extract and artichoke leaf extract have all individually been shown to reduce LDL-cholesterol while hydroxytyrosol has been shown to protect LDL from oxidative damage.
About this study
The study will evaluate the effects of daily consumption of a supplement on serum LDL-cholesterol in adults with hypercholesterolaemia compared to placebo over four months.
Who can participate in this study?
Men and women who are aged 18 to 65 years who experience mild hypercholesterolaemia, but are otherwise healthy, may be eligible to participate in this study. Forty-two individuals will participate in this clinical trial in Adelaide. You must meet all of the below selection criteria. These criteria along with other further criteria related to your health will be assessed for you during the screening process.
- Male or female aged 18-65 inclusive
- Mild hypercholesterolaemia (fasting LDL-cholesterol blood sample at screening visit)
- Body mass index (BMI) >18.5 kg/m2 and <35 kg/m2
- Willing to provide written Informed Consent
- Use of and not prepared to abstain from lipid lowering medications, supplements or fortified foods containing substances that affect lipid concentrations (including statins, metformin, fibrates, cholesterol absorption inhibitors, nicotinic acid, or high dose omega-3 supplements, soluble fibre such as β-glucan/psyllium, plant sterols, curcumin, turmeric)
- Previous diagnosis of chronic disease such as cardiovascular disease (CVD), diabetes, cancer, familial hypercholesterolemia, kidney disease
- Aversion and/or intolerance/allergy to the study intervention products
- Unwilling or unable to maintain usual levels of physical activity for the duration of the study
- History of or known presence of alcohol abuse or illicit drug use, any surgical history, clinically significant conditions (such as. renal, or urological disease, liver disease gastrointestinal disease or any other significant disease) or organ dysfunction that in the opinion of the investigator may affect the participant’s ability to participate in the study or the study results
- Women of childbearing potential who are not currently using effective methods of contraception and have not been using effective methods of contraception for 14 days prior to day 1 and are not willing to use effective methods of contraception throughout the study
- Women of childbearing potential who have a positive urine dipstick pregnancy test at screening or Day 1, or currently pregnant or lactating
- Currently hospitalised or any planned hospitalisations during the study or up to one month following the last dose of the study product that may affect the participant’s ability to comply with the study in the opinion of the Medical Investigator
If you have any queries about this study or would like further information about participating do not hesitate to contact us, either by phone please call (08) 8305 0615 or email CRUstudies@csiro.au and we can assist.
Please register your interest in participating in this study on our participate in a study form. Please ensure that you select supplement for cardiometabolic health in the drop-down menu.
Participants will receive a payment $460 to acknowledge their time and effort and valuable contribution to scientific research.
This study has been approved by the CSIRO Health and Medical Research Human Research Ethics Committee.