HypercholesterolemiaCLoNENCT04783714
Investigating Effects of a Novel Nutraceutical on Hypercholesterolaemia in Australian Adults
A study testing Swisse Nutra+ Cholesterol Balance in people with Hypercholesterolemia, run by Swisse Wellness Pty Ltd at 1 site in Australia.
Trial 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. This is a single-centre, randomised, double-blind, placebo controlled, parallel study. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Swisse Nutra+ Cholesterol Balance
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteAustralia
- Study dates
- 30 Apr 2021to 22 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site
CSIRO Nutrition and Health Research Clinic
Adelaide, South Australia, 5000
About this study
Official title: Investigating the Effects of a Novel Nutraceutical Combination (Swisse Nutra+ Cholesterol Balance) on Low-density Lipoprotein Cholesterol and Other Markers of Cardiometabolic Health in Australian Adults With Hypercholesterolaemia: A Randomised, Double-blind, Placebo Controlled Trial
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.
This is a single-centre, randomised, double-blind, placebo controlled, parallel study.
Read more
Applicants will be eligible to participate if they have hypercholesterolemia, defined by fasting LDL-cholesterol 2.5mmol/L and ≤5 mmol/L confirmed at screening visit. Participants who are otherwise healthy will be included in the study; individuals with a history of cardiovascular disease are excluded from this trial.
Following pre-screening telephone assessment, applicants will attend an in-clinic screening visit and following informed consent, their general health and eligibility for inclusion into the study will be assessed.
On Day 1 eligible participants will be randomly allocated to receive one of two study treatments (intervention or placebo). Participants will consume the assigned treatment daily for four months.
Participants will return to the clinic at months 2 and 4 for assessment of primary and secondary outcomes. Compliance, adverse events and concomitant medication use will be assessed at these visits. In addition, participants will complete an online survey at months 1 and 3 to assess protocol compliance, adverse events and use of concomitant medications. Any queries that arise from the survey will be followed up by phone call.
Dietary intakes will be assessed at the baseline and four-month visits. A final participant online survey and phone call (if needed) will be conducted one month after the 4-month visit for a final safety assessment.
- Conditions
- Hypercholesterolemia
- Being tested
- Swisse Nutra+ Cholesterol Balance, Placebo
- Keywords
- hypercholesterolemia, low-density lipoprotein, nutraceutical, bergamot, artichoke, phytosterols, hydroxytyrosol
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swisse Nutra+ Cholesterol BalanceDietary supplement
Swisse Nutra+ Cholesterol Balance is a multi-ingredient nutraceutical composition contained in a brown soft-gel capsule format. Three capsules are required per dose.Swisse Nutra+ Cholesterol Balance is a multi-ingredient formulation containing artichoke extract, bergamot juice extract, hydroxytyrosol, an antioxidant derived from olive oil and sunflower oil-derived phytosterols. All ingredients target cholesterol reduction by different and complementing mechanisms, as evidenced by human clinical trials. These ingredients have been chosen to work synergistically to alleviate hypercholesterolemia and/or dyslipidemia through multiple pathways, whereby each ingredient works via a different mechanism to lower LDL-cholesterol in the body.
PlaceboDietary supplement
Matched brown soft-gel capsule placebo containing olive oil and palm olein - no therapeutic benefit.
| Study group | Role | What they receive |
|---|---|---|
| Active Group | Experimental | Active treatment comprises of 3 soft gel capsules daily (with food) of Swisse Nutra+ Cholesterol Balance, a novel combination nutraceutical containing bergamot juice extract, artichoke leaf extract, hydroxytyrosol and plant sterols, totaling a daily dose of 375 mg bergamot juice extract, 150 mg artichoke leaf extract, 50 mg hydroxytyrosol and 1.8 g sunflower phytosterols.
Each capsule contains 125mg of bergamot juice extract, 50mg artichoke leaf extract, 16.67mg hydroxytyrosol and 600mg plant sterols.
The intervention will be administered for 4 months (112 days). Receives: Dietary Supplement: Swisse Nutra+ Cholesterol Balance |
| Placebo | Placebo comparator | 3 soft gel capsules of matching placebo daily (total daily dose of 696 mg palm olein and 232 mg olive oil). Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in LDL-cholesterol
Low-density lipoprotein-cholesterol (LDL-C) will be analysed using standardised methods. A Beckman AU480 clinical analyser (Beckman Coulter Inc, Brea, CA, USA) and relevant commercial enzymatic test kits will be used for analysis of serum LDL-cholesterol.
Change in serum LDL-C (mmol/L) from baseline will be recorded.
Measured: From baseline to 4 months
Secondary outcomes (62)
Serum lipid concentrations from baseline
Change in serum lipid concentrations of the following measures (total cholesterol, high-density lipoprotein-cholesterol, triglycerides, non-HDL-C, total cholesterol:HDL-cholesterol ratio, apolipoproteinA1 (apoA1), apolipoproteinB (apoB), apoB:apoA1 ratio) will be analysed. Fasting blood samples (total of ~14 ml) will be collected into vacutainers containing a clot activator for the preparation of serum.
Secondary blood-based outcomes will be analysed using standardised methods. Immunoturbidimetric test kits will be used for analysis of apoA1 and apoB. Total cholesterol:HDL-cholesterol and apoB:apoA1 ratio will be calculated from the results. Non-HDL-cholesterol will be calculated as total cholesterol - HDL-cholesterol.
Measured: From baseline to 4 months
Blood pressure changes from baseline
Resting systolic and diastolic blood pressure (mmHg) will be measured using an automated blood pressure monitor in a seated position following a 5-minute rest. The average of three measurements (separated by 2 minutes) will be recorded.
Measured: From baseline to 4 months
Changes in HbA1c from baseline
Whole Ethylenediaminetetraacetic acid (EDTA) blood samples will be collected to analyse haemoglobin A1C (HbA1c) concentration changes during the study period. A Beckman AU480 clinical analyser (Beckman Coulter Inc, Brea, CA, USA) and relevant commercial enzymatic test kits will be used for analysis of HbA1c.
Measured: From baseline to 4 months
Changes in plasma ox-LDL
Changes in plasma oxidised-low-density lipoprotein will be analysed by commercial ELISA kit. Vacutainers containing K2-EDTA anticoagulant will be used for the preparation of plasma. This assay will be measured on an EnVision Multilabel plate reader (Perkin Elmer, MA, USA).
Measured: From baseline to 4 months
Changes in serum malondialdehyde
Changes in serum malondialdehyde will be analysed by commercial colorimetric assay kit. This assay will be measured on an EnVision Multilabel plate reader (Perkin Elmer, MA, USA).
Measured: From baseline to 4 months
Changes to diet
Participant's habitual dietary intake will be assessed at Baseline and 4 month visits using the Automated Self-Administered 24-hour (ASA24-Australia) Dietary Assessment Tool, version (2016), developed and validated by the National Cancer Institute, Bethesda, MD (36). Three 24-hour recalls will be completed at each occasion. At Day 1, participants will complete the first 24-hour recall during a dietitian consultation while the subsequent 24-hour recalls will be completed by the participant at home within 7-days of Day 1 and on days as specified by the dietitian (including 2 week- and 1 weekend day). Overall, all days of the week will be covered by participants. Nutrient analysis is automated through the ASA24 program and uses the Australian Food, Supplement and Nutrient Database (AUSNUT, 2011-13).
Measured: From baseline to 4 months
Changes in anthropometric measurements - height
Height will be measured at Screening (cm). Height will be measured using a stadiometer.
Waist and hip circumference (cm) will be measured at Baseline, 2- and 4 month or Early Withdrawal visits. Waist will be measured at the top of the iliac crest with a plastic measuring tape and taken at minimal respiration for the average of three consecutive readings. Hip circumference will be measured at the largest circumference of the buttocks.
Measured: From baseline to 4 months
Changes in anthropometric measurements - weight
Body weight (kg) will be measured at screening and Day 1 and also be collected at the 2 month, 4 month or Early Withdrawal visits. Body weight will be measured using calibrated electronic digital scales.
Measured: Baseline to 4 months
Changes in anthropometric measurements - BMI
Body mass index (BMI) will be calculated using the formula weight (kg)/height (m)2. BMI will be assessed at screening, baseline, 2 months, and 4 months.
Measured: Baseline to 4 months.
Changes in anthropometric measurements- WHR
Waist:hip ratio (WHR) will be calculated using the formula waist circumference (cm)/hip circumference (cm). WHR will be calculated from measurements taken at Baseline, 2 and-4 months or Early Withdrawal visits.
Measured: Baseline to 4 months
Changes in body composition
Fat mass and fat free mass will be measured at Baseline, 2- and 4 month or Early Withdrawal visits using a multi-frequency bioelectrical impedance analysis machine with 8 tactile electrodes (InBody 770, Biospace Co. Ltd, Seoul). Measurements will be obtained after voiding. Participants will stand upright, positioning their bare feet on the footpads and their hands on the handles. A small electrical current is passed through the body, resistance is measured, and total body water and the corresponding body composition measures are calculated by the inbuilt software.
Measured: From baseline to 4 months
Safety - Incidence of adverse events (AEs) and serious adverse events (SAEs)
All adverse events will be recorded from dosing until the end of the study (Final Safety Visit or early withdrawal). At clinic visit at month 2 and month 4 and online surveys, participants will be questioned in a non-leading manner regarding the occurrence of any adverse medical event. All AEs will be documented in the source documents and evaluated by the Medical Investigator for severity and causality to study treatment. All SAEs will be reported to the study sponsor as per standard Good Clinical Practice (GCP) requirements.
Measured: From baseline to 4 months
Safety- Number of participants with significant changes to blood pressure over study period between groups
Vital signs will be measured by a designee while the participant is seated. Resting blood pressure (systolic/diastolic mmHG) will be measured using an automated blood pressure monitor in a seated position following a 5-minute rest. The average of three measurements (separated by 2 minutes) will be recorded.Vital signs will be performed at Screening, Baseline, 2 month and 4 month or Early Withdrawal Visit.
Measured: Baseline to 4 months
Safety - Number of participants who fall pregnant (WOCBP only)
A urine sample will be collected at Screening, Baseline, 2 and 4 month Visit or Early Withdrawal visit in WOCBP only. Study staff will perform a dipstick urine pregnancy test and record the result in the source documents.
Measured: Baseline to 4 months
Safety - Number of participants with significant changes to heart rate between groups
Vital signs will be measured by a designee while the participant is seated. Heart rate will be measured as beats/minute by palpating the participants' carotid and radial pulses. Vital signs will be performed at Screening, Baseline, 2 month and 4 month or Early Withdrawal Visit.
Measured: Baseline to 4 months
Number of participants with changes to heart sounds
The Medical Investigator will perform a non-invasive physical examination of the participants' cardiovascular system by listening to heart sounds to determine whether there is a heart murmur or irregular heart beat.
At Day 1 (Baseline visit) these will be reviewed to establish their baseline characteristics.
A symptom directed physical exam will be conducted at 4 months or Early Withdrawal Visit.
Measured: Baseline to 4 months
Safety - Number of participants with significant changes to respiratory rate between groups
Respiratory rate will be measured by counting the number of times the chest rises per minute while the participant is at rest. Vital signs will be performed at Screening, Baseline, 2 month and 4 month or Early Withdrawal Visit.
Measured: Baseline to 4 months
Number of participants with changes to respiratory effort
The Medical Investigator will perform a non-invasive physical examination of the participants' lung function by observing the participants' breathing rhythm and chest movement.
At Day 1 (Baseline visit) these will be reviewed to establish their baseline characteristics.
A symptom directed physical exam will be conducted at 4 months or Early Withdrawal Visit.
Measured: Baseline to 4 months
Safety - Number of participants with significant changes to core body temperature between groups
Vital signs will be measured by a designee while the participant is seated. Body temperature (°C) will be measured using a digital thermometer.
Measured: Baseline to 4 months
Safety: Number of participants with macroscopic abnormalities of the eyes
A non-invasive physical examination will be performed by a Medical Investigator and will include an assessment of the appearance of the pupil, iris, cornea, eyelids, eyelashes, conjuctiva and periorbital are including redness, discharge, lesions, ulcers, abrasions or unusual growths.
At Day 1 (Baseline visit) these will be reviewed to establish their baseline characteristics.
A symptom directed physical exam will be conducted at 4 months or Early Withdrawal Visit.
Measured: Baseline to 4 months
Safety -Number of participants with visual symptoms
Participants will be asked to self-report on any visual symptoms or changes e.g. blurriness, eye strain etc. throughout the study period.
At Day 1 (Baseline visit) these will be reviewed to establish their baseline characteristics.
A symptom directed physical exam will be conducted at 4 months or Early Withdrawal Visit.
Measured: Baseline to 4 months
Safety: Number of participants with infections in the Ears, Nose, Mouth and Throat
A non-invasive physical examination will be performed by a Medical Investigator and will include
- A visual assessment of the ears, nose, mouth and throat to check for signs of infection
- Palpation of the cervical chain lymph nodes to check for signs of infection
At Day 1 (Baseline visit) these will be reviewed to establish their baseline characteristics.
A symptom directed physical exam will be conducted at 4 months or Early Withdrawal Visit.
Measured: Baseline to 4 months
Safety: Number of participants with changes to peripheral vascular function
A non-invasive physical examination will be performed by a Medical Investigator and will include palpating the dorsal pedis pulse, posterior tibial pulse and palpation of the ankles to check for peripheral oedema.
At Day 1 (Baseline visit) these will be reviewed to establish their baseline characteristics.
A symptom directed physical exam will be conducted at 4 months or Early Withdrawal Visit.
Measured: Baseline to 4 months
Safety: Number of participants with respiratory disease
The Medical Investigator will perform a non-invasive physical examination of the participants' respiratory system by listening to breath sounds to determine whether there is untreated asthma or other lung disease.
At Day 1 (Baseline visit) these will be reviewed to establish their baseline characteristics.
A symptom directed physical exam will be conducted at 4 months or Early Withdrawal Visit.
Measured: Baseline to 4 months
Safety: Number of participants with changes to the gastrointestinal tract
Medical Investigator will perform a non-invasive physical exam by observing and palpating the participants' abdomen to check for surgical scars, ascites, organomegaly and abdominal discomfort.
At Day 1 (Baseline visit) these will be reviewed to establish their baseline characteristics.
A symptom directed physical exam will be conducted at 4 months or Early Withdrawal Visit.
Measured: Baseline to 4 months
Safety: Changes to characteristics in physical examination - musculoskeletal
A non-invasive physical examination will be performed by a Medical Investigator and will include an assessment of joint mobility. Participants will be asked to to stand and sit back down into a chair unassisted, to reach forward and try to touch their toes, and to touch their opposite shoulder blades across their front, behind their neck and behind their back (Apley Shoulder test).
At Day 1 (Baseline visit) these will be reviewed to establish their baseline characteristics.
A symptom directed physical exam will be conducted at 4 months or Early Withdrawal Visit.
Measured: Baseline to 4 months
Safety: Number of participants with changes to characteristics in skin appearance
A non-invasive physical examination will be performed by a Medical Investigator who will observe the participants' skin colour, looking for central and peripheral cyanosis, jaundice, or any skin rashes or lesions.
At Day 1 (Baseline visit) these will be reviewed to establish their baseline characteristics.
A symptom directed physical exam will be conducted at 4 months or Early Withdrawal Visit.
Measured: Baseline to 4 months
Safety: Number of participants with clinically significant changes in biochemistry - AST
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in Aspartate aminotransferase (AST) from baseline (U/L) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Measured: Baseline to 4 months
Safety: Number of participants with clinically significant changes in biochemistry- ALT
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in Alanine aminotransferase (ALT) from baseline (U/L) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Measured: Baseline to 4 months
Safety: Number of participants with clinically significant changes in biochemistry - GGT
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in gamma glutamyltransferase from baseline (U/L) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Measured: Baseline to 4 months
Safety: Number of participants with clinically significant changes in biochemistry - ALP
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in Alkaline phosphatase (ALP) (U/L) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Measured: Baseline to 4 months
Safety: Number of participants with clinically significant changes in biochemistry - LD
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in Lactate Dehydrogenase (U/L) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Measured: Baseline to 4 months
Safety: Number of participants with clinically significant changes in biochemistry - creatinine
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in creatinine (µmol/L) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Measured: Baseline to 4 months
Safety: Number of participants with clinically significant changes in biochemistry - creatinine kinase
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in creatinine kinase (U/L) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Measured: Baseline to 4 months
Safety: Number of participants with clinically significant changes in biochemistry - urea nitrogen
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in urea nitrogen (mmol/L) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Measured: Baseline to 4 months
Safety: Number of participants with clinically significant changes in biochemistry - sodium
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in blood sodium levels (mmol/L) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Measured: Baseline to 4 months
Safety: Number of participants with clinically significant changes in biochemistry - potassium
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in blood potassium levels (mmol/L) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Measured: Baseline to 4 months
Safety: Number of participants with clinically significant changes in biochemistry - chloride
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in blood chloride levels (mmol/L) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Measured: Baseline to 4 months
Safety: Number of participants with clinically significant changes in biochemistry - bicarbonate
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in blood bicarbonate levels (mmol/L) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Measured: Baseline to 4 months
Safety: Number of participants with clinically significant changes in biochemistry - urea
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in blood urea levels (mmol/L) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Measured: Baseline to 4 months
Safety: Number of participants with clinically significant changes in biochemistry - calcium
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in calcium levels (mmol/L) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Measured: Baseline to 4 months
Safety: Number of participants with clinically significant changes in biochemistry - CRP
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in C-reactive protein levels (CRP) measured as mg/L will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Measured: Baseline to 4 months
Safety: Number of participants with clinically significant changes in biochemistry - uric acid
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in uric acid measured as mol/mol will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Measured: Baseline to 4 months
Safety: Number of participants with clinically significant changes in biochemistry - phosphate
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in phosphate (mmol/L) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Measured: Baseline to 4 months
Safety: Number of participants with clinically significant changes in biochemistry - albumin
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in albumin (g/L) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Measured: Baseline to 4 months
Safety: Number of participants with clinically significant changes in biochemistry - globulins
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in globulins (g/L) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Measured: Baseline to 4 months
Safety: Number of participants with clinically significant changes in biochemistry - protein
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in protein (g/L) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Measured: Baseline to 4 months
Safety: Number of participants with clinically significant changes in biochemistry - total bilirubin
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in total bilirubin (umol/L) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Measured: Baseline to 4 months
Safety: Number of participants with clinically significant changes in biochemistry - glucose
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in fasting glucose (mmol/L) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Measured: Baseline to 4 months
Safety: Number of participants with clinically significant changes in haematology - RDW
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in red cell distribution (RDW) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Measured: Baseline to 4 months
Safety: Number of participants with clinically significant changes in haematology - haemoglobin
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in haemoglobin (g/L) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Measured: Baseline to 4 months
Safety: Number of participants with clinically significant changes in haematology - RBC
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in red blood cell count (RBC) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Measured: Baseline to 4 months
Safety: Number of participants with clinically significant changes in haematology - PCV
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in packed cell volume (PCV) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Measured: Baseline to 4 months
Safety: Number of participants with clinically significant changes in haematology - MCV
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in mean cell volume (MCV) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Measured: Baseline to 4 months
Safety: Number of participants with clinically significant changes in haematology - MCHC
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in mean cell hemoglobin concentrations (MCHC) measured as g/L will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Measured: Baseline to 4 months
Safety: Number of participants with clinically significant changes in haematology - platelets
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in the number of platelets will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Measured: Baseline to 4 months
Safety: Number of participants with clinically significant changes in haematology - white cell count (WCC)
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in the number of white cells will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Measured: Baseline to 4 months
Safety: Number of participants with clinically significant changes in haematology - neutrophils
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
A white cell count differential test will be conducted. Changes in the number of neutrophils will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Measured: Baseline to 4 months
Safety: Number of participants with clinically significant changes in haematology - lymphocytes
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
A white cell count differential test will be conducted. Changes in the number of lymphocytes will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Measured: Baseline to 4 months
Safety: Number of participants with clinically significant changes in haematology - monocytes
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
A white cell count differential test will be conducted. Changes in the number of monocytes will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Measured: Baseline to 4 months
Safety: Number of participants with clinically significant changes in haematology - eosinophils
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
A white cell count differential test will be conducted. Changes in the number of eosinophils will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Measured: Baseline to 4 months
Safety: Number of participants with clinically significant changes in haematology - basophils
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
A white cell count differential test will be conducted. Changes in the number of basophils will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Measured: Baseline to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start30 Apr 2021
- Primary completion22 Oct 2021
- Study completion22 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Treatment arm and Placebo arm
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swisse Wellness Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Commonwealth Scientific & Industrial Research Organisation, BIONAP SRL
- Responsible party
- Sponsor
- Investigators
- Welma Stonehouse, PhD, Principal investigator, Commonwealth Scientific and Industrial Research Organisation, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04783714
- Sponsor's protocol ID
- SNC-001
- Acronym
- CLoNE
- Status last verified
- Apr 2021
- First submitted
- 11 Feb 2021
- Last updated
- 11 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stonehouse W, Benassi-Evans B, Louise J. The effects of a novel nutraceutical combination on low-density lipoprotein cholesterol and other markers of cardiometabolic health in adults with hypercholesterolaemia: A randomised double-blind placebo-controlled trial. Atherosclerosis. 2025 Apr;403:119177. doi: 10.1016/j.atherosclerosis.2025.119177. Epub 2025 Mar 22.
PubMed 40147213
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effects of a Novel Nutraceutical Combination (Swisse Nutra+ Cholesterol Balance) on Low-density Lipoprotein Cholesterol and Other Markers of Cardiometabolic Health in Australian Adults With Hypercholesterolaemia: A Randomised, Double-blind, Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT04783714
- Acronym / sponsor ID
- CLoNE / SNC-001
- Conditions
- Hypercholesterolemia
- Keywords
- hypercholesterolemia, low-density lipoprotein, nutraceutical, bergamot, artichoke, phytosterols, hydroxytyrosol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Swisse Wellness Pty LtdIndustry (pharma, biotech, devices)
- Collaborators
- Commonwealth Scientific & Industrial Research Organisation, BIONAP SRL
- Study start
- 30 Apr 2021 (actual)
- Primary completion
- 22 Oct 2021 (actual)
- Study completion
- 22 Oct 2021 (actual)
- First posted
- 5 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
This is a single-centre, randomised, double-blind, placebo controlled, parallel study.
Applicants will be eligible to participate if they have hypercholesterolemia, defined by fasting LDL-cholesterol 2.5mmol/L and ≤5 mmol/L confirmed at screening visit. Participants who are otherwise healthy will be included in the study; individuals with a history of cardiovascular disease are excluded from this trial.
Following pre-screening telephone assessment, applicants will attend an in-clinic screening visit and following informed consent, their general health and eligibility for inclusion into the study will be assessed.
On Day 1 eligible participants will be randomly allocated to receive one of two study treatments (intervention or placebo). Participants will consume the assigned treatment daily for four months.
Participants will return to the clinic at months 2 and 4 for assessment of primary and secondary outcomes. Compliance, adverse events and concomitant medication use will be assessed at these visits. In addition, participants will complete an online survey at months 1 and 3 to assess protocol compliance, adverse events and use of concomitant medications. Any queries that arise from the survey will be followed up by phone call.
Dietary intakes will be assessed at the baseline and four-month visits. A final participant online survey and phone call (if needed) will be conducted one month after the 4-month visit for a final safety assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Treatment arm and Placebo arm
| Arm | Type | Receives |
|---|---|---|
| Active Group | Experimental | Dietary Supplement: Swisse Nutra+ Cholesterol BalanceActive treatment comprises of 3 soft gel capsules daily (with food) of Swisse Nutra+ Cholesterol Balance, a novel combination nutraceutical containing bergamot juice extract, artichoke leaf extract, hydroxytyrosol and plant sterols, totaling a daily dose of 375 mg bergamot juice extract, 150 mg artichoke leaf extract, 50 mg hydroxytyrosol and 1.8 g sunflower phytosterols. Each capsule contains 125mg of bergamot juice extract, 50mg artichoke leaf extract, 16.67mg hydroxytyrosol and 600mg plant sterols. The intervention will be administered for 4 months (112 days). |
| Placebo | Placebo comparator | Dietary Supplement: Placebo3 soft gel capsules of matching placebo daily (total daily dose of 696 mg palm olein and 232 mg olive oil). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Swisse Nutra+ Cholesterol BalanceSwisse Nutra+ Cholesterol Balance is a multi-ingredient nutraceutical composition contained in a brown soft-gel capsule format. Three capsules are required per dose.Swisse Nutra+ Cholesterol Balance is a multi-ingredient formulation containing artichoke extract, bergamot juice extract, hydroxytyrosol, an antioxidant derived from olive oil and sunflower oil-derived phytosterols. All ingredients target cholesterol reduction by different and complementing mechanisms, as evidenced by human clinical trials. These ingredients have been chosen to work synergistically to alleviate hypercholesterolemia and/or dyslipidemia through multiple pathways, whereby each ingredient works via a different mechanism to lower LDL-cholesterol in the body. | Dietary supplement | Active Group |
| PlaceboMatched brown soft-gel capsule placebo containing olive oil and palm olein - no therapeutic benefit. | Dietary supplement | Placebo |
Primary outcome
Change in LDL-cholesterol
Time frame: From baseline to 4 months
Low-density lipoprotein-cholesterol (LDL-C) will be analysed using standardised methods. A Beckman AU480 clinical analyser (Beckman Coulter Inc, Brea, CA, USA) and relevant commercial enzymatic test kits will be used for analysis of serum LDL-cholesterol. Change in serum LDL-C (mmol/L) from baseline will be recorded.
62 secondary outcomes
Serum lipid concentrations from baseline
Time frame: From baseline to 4 months
Blood pressure changes from baseline
Time frame: From baseline to 4 months
Changes in HbA1c from baseline
Time frame: From baseline to 4 months
Changes in plasma ox-LDL
Time frame: From baseline to 4 months
Changes in serum malondialdehyde
Time frame: From baseline to 4 months
Changes to diet
Time frame: From baseline to 4 months
Changes in anthropometric measurements - height
Time frame: From baseline to 4 months
Changes in anthropometric measurements - weight
Time frame: Baseline to 4 months
Changes in anthropometric measurements - BMI
Time frame: Baseline to 4 months.
Changes in anthropometric measurements- WHR
Time frame: Baseline to 4 months
Changes in body composition
Time frame: From baseline to 4 months
Safety - Incidence of adverse events (AEs) and serious adverse events (SAEs)
Time frame: From baseline to 4 months
Safety- Number of participants with significant changes to blood pressure over study period between groups
Time frame: Baseline to 4 months
Safety - Number of participants who fall pregnant (WOCBP only)
Time frame: Baseline to 4 months
Safety - Number of participants with significant changes to heart rate between groups
Time frame: Baseline to 4 months
Number of participants with changes to heart sounds
Time frame: Baseline to 4 months
Safety - Number of participants with significant changes to respiratory rate between groups
Time frame: Baseline to 4 months
Number of participants with changes to respiratory effort
Time frame: Baseline to 4 months
Safety - Number of participants with significant changes to core body temperature between groups
Time frame: Baseline to 4 months
Safety: Number of participants with macroscopic abnormalities of the eyes
Time frame: Baseline to 4 months
Safety -Number of participants with visual symptoms
Time frame: Baseline to 4 months
Safety: Number of participants with infections in the Ears, Nose, Mouth and Throat
Time frame: Baseline to 4 months
Safety: Number of participants with changes to peripheral vascular function
Time frame: Baseline to 4 months
Safety: Number of participants with respiratory disease
Time frame: Baseline to 4 months
Safety: Number of participants with changes to the gastrointestinal tract
Time frame: Baseline to 4 months
Safety: Changes to characteristics in physical examination - musculoskeletal
Time frame: Baseline to 4 months
Safety: Number of participants with changes to characteristics in skin appearance
Time frame: Baseline to 4 months
Safety: Number of participants with clinically significant changes in biochemistry - AST
Time frame: Baseline to 4 months
Safety: Number of participants with clinically significant changes in biochemistry- ALT
Time frame: Baseline to 4 months
Safety: Number of participants with clinically significant changes in biochemistry - GGT
Time frame: Baseline to 4 months
Safety: Number of participants with clinically significant changes in biochemistry - ALP
Time frame: Baseline to 4 months
Safety: Number of participants with clinically significant changes in biochemistry - LD
Time frame: Baseline to 4 months
Safety: Number of participants with clinically significant changes in biochemistry - creatinine
Time frame: Baseline to 4 months
Safety: Number of participants with clinically significant changes in biochemistry - creatinine kinase
Time frame: Baseline to 4 months
Safety: Number of participants with clinically significant changes in biochemistry - urea nitrogen
Time frame: Baseline to 4 months
Safety: Number of participants with clinically significant changes in biochemistry - sodium
Time frame: Baseline to 4 months
Safety: Number of participants with clinically significant changes in biochemistry - potassium
Time frame: Baseline to 4 months
Safety: Number of participants with clinically significant changes in biochemistry - chloride
Time frame: Baseline to 4 months
Safety: Number of participants with clinically significant changes in biochemistry - bicarbonate
Time frame: Baseline to 4 months
Safety: Number of participants with clinically significant changes in biochemistry - urea
Time frame: Baseline to 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2022.
- Derived from this study: PubMed 40147213Stonehouse W, Benassi-Evans B, Louise J. The effects of a novel nutraceutical combination on low-density lipoprotein cholesterol and other markers of cardiometabolic health in adults with hypercholesterolaemia: A randomised double-blind placebo-controlled trial. Atherosclerosis. 2025 Apr;403:119177. doi: 10.1016/j.atherosclerosis.2025.119177. Epub 2025 Mar 22.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Welma Stonehouse, PhD principal investigator
Commonwealth Scientific and Industrial Research Organisation, Australia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Swisse Nutra+ Cholesterol Balance in people with Hypercholesterolemia, run by Swisse Wellness Pty Ltd at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in LDL-cholesterol (time frame: From baseline to 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04783714, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2022.