Status:
COMPLETED
Investigating Effects of a Novel Nutraceutical on Hypercholesterolaemia in Australian Adults
Lead Sponsor:
Swisse Wellness Pty Ltd
Collaborating Sponsors:
Commonwealth Scientific & Industrial Research Organisation
BIONAP SRL
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
To evaluate the effects of daily consumption of 3 capsules of Swisse Nutra+ Cholesterol Balance on serum LDL-cholesterol in adults with hypercholesterolaemia compared to placebo over four months. Thi...
Eligibility Criteria
Inclusion
- Male or female aged 18-65 inclusive
- Fasting LDL-cholesterol ≥2.5mmol/L and ≤5mmol/L\* confirmed at screening visit
- Low cardiovascular disease (CVD) risk score (for individuals aged 45-65 years, inclusive) determined using Framingham Risk Equation \<10% absolute risk of CVD events over 5 years# as determined using a risk calculator (1) or in the event that this is not available using Australian cardiovascular risk charts (2)
- Body mass index (BMI) \>18.5 kg/m2 and \<35 kg/m2 confirmed during screening period and Day 1
- Willing to provide written Informed Consent
Exclusion
- Serum LDL-cholesterol \>5 mmol/L\* at screening
- Use of omega-3 supplements at high dose (\>900 mg/day of docosahexaenoic acid (DHA) / eicosapentaenoic acid (EPA))
- Use of and not prepared to abstain from lipid lowering medications, supplements or fortified foods containing substances that may, in the opinion of the medical investigator, affect lipid concentrations (e.g. statins, metformin, fibrates, cholesterol absorption inhibitors, nicotinic acid, or omega-3 supplements \<900 mg/day DHA/EPA) , soluble fibre, e.g. β-glucan/psyllium, plant sterols, curcumin/turmeric) within past 28 days of Day 1
- Previous diagnosis of chronic disease such as CVD, diabetes, cancer, familial hypercholesterolaemia, kidney disease
- Smoking (i.e. history of smoking within the last six months)
- Serum triglycerides \>4.5mmol/L (LDL-cholesterol concentrations are unreliable in the presence of high triglyceride levels)
- Women of childbearing potential (WOCBP) 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
- WOCBP who have a positive urine dipstick pregnancy test at screening or Day 1, or currently pregnant or lactating
- Untreated hypertension (blood pressure ≥140/90mmHg)
- 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 (i.e. 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
- 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
- Received an investigational drug within 3 months prior to Day 1 that in the opinion of the investigator may affect the applicant's ability to participate in the study or the study results
Key Trial Info
Start Date :
April 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 22 2021
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04783714
Start Date
April 30 2021
End Date
October 22 2021
Last Update
March 11 2022
Active Locations (1)
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1
CSIRO Nutrition and Health Research Clinic
Adelaide, South Australia, Australia, 5000