Clinical trial NCT04783714: Investigating Effects of a Novel Nutraceutical on Hypercholesterolaemia in Australian Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercholesterolemia
Keywords: hypercholesterolemia
low-density lipoprotein
nutraceutical
bergamot
artichoke
phytosterols
hydroxytyrosol
Lead sponsor: Swisse Wellness Pty Ltd
Sponsor class: INDUSTRY
Collaborators: name: Commonwealth Scientific & Industrial Research Organisation
name: BIONAP SRL
First posted: 2021-03-05
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Treatment arm and Placebo arm
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

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. β-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

Primary outcomes:
measure: Change in LDL-cholesterol
timeFrame: From baseline to 4 months
Secondary outcomes:
measure: Serum lipid concentrations from baseline
timeFrame: From baseline to 4 months
measure: Blood pressure changes from baseline
timeFrame: From baseline to 4 months
measure: Changes in HbA1c from baseline
timeFrame: From baseline to 4 months
measure: Changes in plasma ox-LDL
timeFrame: From baseline to 4 months
measure: Changes in serum malondialdehyde
timeFrame: From baseline to 4 months
measure: Changes to diet
timeFrame: From baseline to 4 months
measure: Changes in anthropometric measurements - height
timeFrame: From baseline to 4 months
measure: Changes in anthropometric measurements - weight
timeFrame: Baseline to 4 months
measure: Changes in anthropometric measurements - BMI
timeFrame: Baseline to 4 months.
measure: Changes in anthropometric measurements- WHR
timeFrame: Baseline to 4 months
measure: Changes in body composition
timeFrame: From baseline to 4 months
measure: Safety - Incidence of adverse events (AEs) and serious adverse events (SAEs)
timeFrame: From baseline to 4 months
measure: Safety- Number of participants with significant changes to blood pressure over study period between groups
timeFrame: Baseline to 4 months
measure: Safety - Number of participants who fall pregnant (WOCBP only)
timeFrame: Baseline to 4 months
measure: Safety - Number of participants with significant changes to heart rate between groups
timeFrame: Baseline to 4 months
measure: Number of participants with changes to heart sounds
timeFrame: Baseline to 4 months
measure: Safety - Number of participants with significant changes to respiratory rate between groups
timeFrame: Baseline to 4 months
measure: Number of participants with changes to respiratory effort
timeFrame: Baseline to 4 months
measure: Safety - Number of participants with significant changes to core body temperature between groups
timeFrame: Baseline to 4 months
measure: Safety: Number of participants with macroscopic abnormalities of the eyes
timeFrame: Baseline to 4 months
measure: Safety -Number of participants with visual symptoms
timeFrame: Baseline to 4 months
measure: Safety: Number of participants with infections in the Ears, Nose, Mouth and Throat
timeFrame: Baseline to 4 months
measure: Safety: Number of participants with changes to peripheral vascular function
timeFrame: Baseline to 4 months
measure: Safety: Number of participants with respiratory disease
timeFrame: Baseline to 4 months
measure: Safety: Number of participants with changes to the gastrointestinal tract
timeFrame: Baseline to 4 months
measure: Safety: Changes to characteristics in physical examination - musculoskeletal
timeFrame: Baseline to 4 months
measure: Safety: Number of participants with changes to characteristics in skin appearance
timeFrame: Baseline to 4 months
measure: Safety: Number of participants with clinically significant changes in biochemistry - AST
timeFrame: Baseline to 4 months
measure: Safety: Number of participants with clinically significant changes in biochemistry- ALT
timeFrame: Baseline to 4 months
measure: Safety: Number of participants with clinically significant changes in biochemistry - GGT
timeFrame: Baseline to 4 months
measure: Safety: Number of participants with clinically significant changes in biochemistry - ALP
timeFrame: Baseline to 4 months
measure: Safety: Number of participants with clinically significant changes in biochemistry - LD
timeFrame: Baseline to 4 months
measure: Safety: Number of participants with clinically significant changes in biochemistry - creatinine
timeFrame: Baseline to 4 months
measure: Safety: Number of participants with clinically significant changes in biochemistry - creatinine kinase
timeFrame: Baseline to 4 months
measure: Safety: Number of participants with clinically significant changes in biochemistry - urea nitrogen
timeFrame: Baseline to 4 months
measure: Safety: Number of participants with clinically significant changes in biochemistry - sodium
timeFrame: Baseline to 4 months
measure: Safety: Number of participants with clinically significant changes in biochemistry - potassium
timeFrame: Baseline to 4 months
measure: Safety: Number of participants with clinically significant changes in biochemistry - chloride
timeFrame: Baseline to 4 months
measure: Safety: Number of participants with clinically significant changes in biochemistry - bicarbonate
timeFrame: Baseline to 4 months
measure: Safety: Number of participants with clinically significant changes in biochemistry - urea
timeFrame: Baseline to 4 months
measure: Safety: Number of participants with clinically significant changes in biochemistry - calcium
timeFrame: Baseline to 4 months
measure: Safety: Number of participants with clinically significant changes in biochemistry - CRP
timeFrame: Baseline to 4 months
measure: Safety: Number of participants with clinically significant changes in biochemistry - uric acid
timeFrame: Baseline to 4 months
measure: Safety: Number of participants with clinically significant changes in biochemistry - phosphate
timeFrame: Baseline to 4 months
measure: Safety: Number of participants with clinically significant changes in biochemistry - albumin
timeFrame: Baseline to 4 months
measure: Safety: Number of participants with clinically significant changes in biochemistry - globulins
timeFrame: Baseline to 4 months
measure: Safety: Number of participants with clinically significant changes in biochemistry - protein
timeFrame: Baseline to 4 months
measure: Safety: Number of participants with clinically significant changes in biochemistry - total bilirubin
timeFrame: Baseline to 4 months
measure: Safety: Number of participants with clinically significant changes in biochemistry - glucose
timeFrame: Baseline to 4 months
measure: Safety: Number of participants with clinically significant changes in haematology - RDW
timeFrame: Baseline to 4 months
measure: Safety: Number of participants with clinically significant changes in haematology - haemoglobin
timeFrame: Baseline to 4 months
measure: Safety: Number of participants with clinically significant changes in haematology - RBC
timeFrame: Baseline to 4 months
measure: Safety: Number of participants with clinically significant changes in haematology - PCV
timeFrame: Baseline to 4 months
measure: Safety: Number of participants with clinically significant changes in haematology - MCV
timeFrame: Baseline to 4 months
measure: Safety: Number of participants with clinically significant changes in haematology - MCHC
timeFrame: Baseline to 4 months
measure: Safety: Number of participants with clinically significant changes in haematology - platelets
timeFrame: Baseline to 4 months
measure: Safety: Number of participants with clinically significant changes in haematology - white cell count (WCC)
timeFrame: Baseline to 4 months
measure: Safety: Number of participants with clinically significant changes in haematology - neutrophils
timeFrame: Baseline to 4 months
measure: Safety: Number of participants with clinically significant changes in haematology - lymphocytes
timeFrame: Baseline to 4 months
measure: Safety: Number of participants with clinically significant changes in haematology - monocytes
timeFrame: Baseline to 4 months
measure: Safety: Number of participants with clinically significant changes in haematology - eosinophils
timeFrame: Baseline to 4 months
measure: Safety: Number of participants with clinically significant changes in haematology - basophils
timeFrame: Baseline to 4 months
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: CSIRO Nutrition and Health Research Clinic
state: South Australia
Study officials:
affiliation: Commonwealth Scientific and Industrial Research Organisation, Australia
name: Welma Stonehouse, PhD
role: PRINCIPAL_INVESTIGATOR
References: