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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04783714




Registration number
NCT04783714
Ethics application status
Date submitted
11/02/2021
Date registered
5/03/2021
Date last updated
11/03/2022

Titles & IDs
Public title
Investigating Effects of a Novel Nutraceutical on Hypercholesterolaemia in Australian Adults
Scientific 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
Secondary ID [1] 0 0
SNC-001
Universal Trial Number (UTN)
Trial acronym
CLoNE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypercholesterolemia 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Swisse Nutra+ Cholesterol Balance
Other interventions - Placebo

Experimental: Active Group - 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).

Placebo Comparator: Placebo - 3 soft gel capsules of matching placebo daily (total daily dose of 696 mg palm olein and 232 mg olive oil).


Other interventions: Swisse Nutra+ Cholesterol Balance
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.

Other interventions: Placebo
Matched brown soft-gel capsule placebo containing olive oil and palm olein - no therapeutic benefit.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in LDL-cholesterol
Timepoint [1] 0 0
From baseline to 4 months
Secondary outcome [1] 0 0
Serum lipid concentrations from baseline
Timepoint [1] 0 0
From baseline to 4 months
Secondary outcome [2] 0 0
Blood pressure changes from baseline
Timepoint [2] 0 0
From baseline to 4 months
Secondary outcome [3] 0 0
Changes in HbA1c from baseline
Timepoint [3] 0 0
From baseline to 4 months
Secondary outcome [4] 0 0
Changes in plasma ox-LDL
Timepoint [4] 0 0
From baseline to 4 months
Secondary outcome [5] 0 0
Changes in serum malondialdehyde
Timepoint [5] 0 0
From baseline to 4 months
Secondary outcome [6] 0 0
Changes to diet
Timepoint [6] 0 0
From baseline to 4 months
Secondary outcome [7] 0 0
Changes in anthropometric measurements - height
Timepoint [7] 0 0
From baseline to 4 months
Secondary outcome [8] 0 0
Changes in anthropometric measurements - weight
Timepoint [8] 0 0
Baseline to 4 months
Secondary outcome [9] 0 0
Changes in anthropometric measurements - BMI
Timepoint [9] 0 0
Baseline to 4 months.
Secondary outcome [10] 0 0
Changes in anthropometric measurements- WHR
Timepoint [10] 0 0
Baseline to 4 months
Secondary outcome [11] 0 0
Changes in body composition
Timepoint [11] 0 0
From baseline to 4 months
Secondary outcome [12] 0 0
Safety - Incidence of adverse events (AEs) and serious adverse events (SAEs)
Timepoint [12] 0 0
From baseline to 4 months
Secondary outcome [13] 0 0
Safety- Number of participants with significant changes to blood pressure over study period between groups
Timepoint [13] 0 0
Baseline to 4 months
Secondary outcome [14] 0 0
Safety - Number of participants who fall pregnant (WOCBP only)
Timepoint [14] 0 0
Baseline to 4 months
Secondary outcome [15] 0 0
Safety - Number of participants with significant changes to heart rate between groups
Timepoint [15] 0 0
Baseline to 4 months
Secondary outcome [16] 0 0
Number of participants with changes to heart sounds
Timepoint [16] 0 0
Baseline to 4 months
Secondary outcome [17] 0 0
Safety - Number of participants with significant changes to respiratory rate between groups
Timepoint [17] 0 0
Baseline to 4 months
Secondary outcome [18] 0 0
Number of participants with changes to respiratory effort
Timepoint [18] 0 0
Baseline to 4 months
Secondary outcome [19] 0 0
Safety - Number of participants with significant changes to core body temperature between groups
Timepoint [19] 0 0
Baseline to 4 months
Secondary outcome [20] 0 0
Safety: Number of participants with macroscopic abnormalities of the eyes
Timepoint [20] 0 0
Baseline to 4 months
Secondary outcome [21] 0 0
Safety -Number of participants with visual symptoms
Timepoint [21] 0 0
Baseline to 4 months
Secondary outcome [22] 0 0
Safety: Number of participants with infections in the Ears, Nose, Mouth and Throat
Timepoint [22] 0 0
Baseline to 4 months
Secondary outcome [23] 0 0
Safety: Number of participants with changes to peripheral vascular function
Timepoint [23] 0 0
Baseline to 4 months
Secondary outcome [24] 0 0
Safety: Number of participants with respiratory disease
Timepoint [24] 0 0
Baseline to 4 months
Secondary outcome [25] 0 0
Safety: Number of participants with changes to the gastrointestinal tract
Timepoint [25] 0 0
Baseline to 4 months
Secondary outcome [26] 0 0
Safety: Changes to characteristics in physical examination - musculoskeletal
Timepoint [26] 0 0
Baseline to 4 months
Secondary outcome [27] 0 0
Safety: Number of participants with changes to characteristics in skin appearance
Timepoint [27] 0 0
Baseline to 4 months
Secondary outcome [28] 0 0
Safety: Number of participants with clinically significant changes in biochemistry - AST
Timepoint [28] 0 0
Baseline to 4 months
Secondary outcome [29] 0 0
Safety: Number of participants with clinically significant changes in biochemistry- ALT
Timepoint [29] 0 0
Baseline to 4 months
Secondary outcome [30] 0 0
Safety: Number of participants with clinically significant changes in biochemistry - GGT
Timepoint [30] 0 0
Baseline to 4 months
Secondary outcome [31] 0 0
Safety: Number of participants with clinically significant changes in biochemistry - ALP
Timepoint [31] 0 0
Baseline to 4 months
Secondary outcome [32] 0 0
Safety: Number of participants with clinically significant changes in biochemistry - LD
Timepoint [32] 0 0
Baseline to 4 months
Secondary outcome [33] 0 0
Safety: Number of participants with clinically significant changes in biochemistry - creatinine
Timepoint [33] 0 0
Baseline to 4 months
Secondary outcome [34] 0 0
Safety: Number of participants with clinically significant changes in biochemistry - creatinine kinase
Timepoint [34] 0 0
Baseline to 4 months
Secondary outcome [35] 0 0
Safety: Number of participants with clinically significant changes in biochemistry - urea nitrogen
Timepoint [35] 0 0
Baseline to 4 months
Secondary outcome [36] 0 0
Safety: Number of participants with clinically significant changes in biochemistry - sodium
Timepoint [36] 0 0
Baseline to 4 months
Secondary outcome [37] 0 0
Safety: Number of participants with clinically significant changes in biochemistry - potassium
Timepoint [37] 0 0
Baseline to 4 months
Secondary outcome [38] 0 0
Safety: Number of participants with clinically significant changes in biochemistry - chloride
Timepoint [38] 0 0
Baseline to 4 months
Secondary outcome [39] 0 0
Safety: Number of participants with clinically significant changes in biochemistry - bicarbonate
Timepoint [39] 0 0
Baseline to 4 months
Secondary outcome [40] 0 0
Safety: Number of participants with clinically significant changes in biochemistry - urea
Timepoint [40] 0 0
Baseline to 4 months
Secondary outcome [41] 0 0
Safety: Number of participants with clinically significant changes in biochemistry - calcium
Timepoint [41] 0 0
Baseline to 4 months
Secondary outcome [42] 0 0
Safety: Number of participants with clinically significant changes in biochemistry - CRP
Timepoint [42] 0 0
Baseline to 4 months
Secondary outcome [43] 0 0
Safety: Number of participants with clinically significant changes in biochemistry - uric acid
Timepoint [43] 0 0
Baseline to 4 months
Secondary outcome [44] 0 0
Safety: Number of participants with clinically significant changes in biochemistry - phosphate
Timepoint [44] 0 0
Baseline to 4 months
Secondary outcome [45] 0 0
Safety: Number of participants with clinically significant changes in biochemistry - albumin
Timepoint [45] 0 0
Baseline to 4 months
Secondary outcome [46] 0 0
Safety: Number of participants with clinically significant changes in biochemistry - globulins
Timepoint [46] 0 0
Baseline to 4 months
Secondary outcome [47] 0 0
Safety: Number of participants with clinically significant changes in biochemistry - protein
Timepoint [47] 0 0
Baseline to 4 months
Secondary outcome [48] 0 0
Safety: Number of participants with clinically significant changes in biochemistry - total bilirubin
Timepoint [48] 0 0
Baseline to 4 months
Secondary outcome [49] 0 0
Safety: Number of participants with clinically significant changes in biochemistry - glucose
Timepoint [49] 0 0
Baseline to 4 months
Secondary outcome [50] 0 0
Safety: Number of participants with clinically significant changes in haematology - RDW
Timepoint [50] 0 0
Baseline to 4 months
Secondary outcome [51] 0 0
Safety: Number of participants with clinically significant changes in haematology - haemoglobin
Timepoint [51] 0 0
Baseline to 4 months
Secondary outcome [52] 0 0
Safety: Number of participants with clinically significant changes in haematology - RBC
Timepoint [52] 0 0
Baseline to 4 months
Secondary outcome [53] 0 0
Safety: Number of participants with clinically significant changes in haematology - PCV
Timepoint [53] 0 0
Baseline to 4 months
Secondary outcome [54] 0 0
Safety: Number of participants with clinically significant changes in haematology - MCV
Timepoint [54] 0 0
Baseline to 4 months
Secondary outcome [55] 0 0
Safety: Number of participants with clinically significant changes in haematology - MCHC
Timepoint [55] 0 0
Baseline to 4 months
Secondary outcome [56] 0 0
Safety: Number of participants with clinically significant changes in haematology - platelets
Timepoint [56] 0 0
Baseline to 4 months
Secondary outcome [57] 0 0
Safety: Number of participants with clinically significant changes in haematology - white cell count (WCC)
Timepoint [57] 0 0
Baseline to 4 months
Secondary outcome [58] 0 0
Safety: Number of participants with clinically significant changes in haematology - neutrophils
Timepoint [58] 0 0
Baseline to 4 months
Secondary outcome [59] 0 0
Safety: Number of participants with clinically significant changes in haematology - lymphocytes
Timepoint [59] 0 0
Baseline to 4 months
Secondary outcome [60] 0 0
Safety: Number of participants with clinically significant changes in haematology - monocytes
Timepoint [60] 0 0
Baseline to 4 months
Secondary outcome [61] 0 0
Safety: Number of participants with clinically significant changes in haematology - eosinophils
Timepoint [61] 0 0
Baseline to 4 months
Secondary outcome [62] 0 0
Safety: Number of participants with clinically significant changes in haematology - basophils
Timepoint [62] 0 0
Baseline to 4 months

Eligibility
Key inclusion criteria
1. Male or female aged 18-65 inclusive

2. Fasting LDL-cholesterol =2.5mmol/L and =5mmol/L* confirmed at screening visit

3. 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)

4. Body mass index (BMI) >18.5 kg/m2 and <35 kg/m2 confirmed during screening period and
Day 1

5. Willing to provide written Informed Consent
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Serum LDL-cholesterol >5 mmol/L* at screening

2. Use of omega-3 supplements at high dose (>900 mg/day of docosahexaenoic acid (DHA) /
eicosapentaenoic acid (EPA))

3. 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. ß-glucan/psyllium, plant sterols, curcumin/turmeric)
within past 28 days of Day 1

4. Previous diagnosis of chronic disease such as CVD, diabetes, cancer, familial
hypercholesterolaemia, kidney disease

5. Smoking (i.e. history of smoking within the last six months)

6. Serum triglycerides >4.5mmol/L (LDL-cholesterol concentrations are unreliable in the
presence of high triglyceride levels)

7. Women of childbearing potential (WOCBP) who:

1. Are not currently using effective methods of contraception and

2. Have not been using effective methods of contraception for 14 days prior to day 1
and

3. Are not willing to use effective methods of contraception throughout the study

8. WOCBP who have a positive urine dipstick pregnancy test at screening or Day 1, or
currently pregnant or lactating

9. Untreated hypertension (blood pressure =140/90mmHg)

10. Aversion and/or intolerance/allergy to the study intervention products ^

11. Unwilling or unable to maintain usual levels of physical activity for the duration of
the study

12. 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

13. 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

14. 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/04/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/10/2021
Sample size
Target
Accrual to date
Final
42
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
CSIRO Nutrition and Health Research Clinic - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Swisse Wellness Pty Ltd
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Commonwealth Scientific & Industrial Research Organisation
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
BIONAP SRL
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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.

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04783714
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Welma Stonehouse, PhD
Address 0 0
Commonwealth Scientific and Industrial Research Organisation, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries