NCT04783714CompletedNot Applicable
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
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Swisse Wellness Pty Ltd
- Enrollment
- 42
- Locations
- 2
- Primary Endpoint
- Change in LDL-cholesterol
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Double-blind
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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 Criteria
- •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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Blood pressure changes from baseline(From baseline to 4 months)
- Changes in plasma ox-LDL(From baseline to 4 months)
- Changes to diet(From baseline to 4 months)
- Safety: Number of participants with clinically significant changes in biochemistry - AST(Baseline to 4 months)
- Changes in anthropometric measurements - BMI(Baseline to 4 months.)
- Safety- Number of participants with significant changes to blood pressure over study period between groups(Baseline to 4 months)
- Safety - Number of participants with significant changes to core body temperature between groups(Baseline to 4 months)
- Changes in anthropometric measurements - weight(Baseline to 4 months)
- Changes in anthropometric measurements- WHR(Baseline to 4 months)
- Changes in body composition(From baseline to 4 months)
- Safety - Number of participants with significant changes to heart rate between groups(Baseline to 4 months)
- Changes in anthropometric measurements - height(From baseline to 4 months)
- Safety - Incidence of adverse events (AEs) and serious adverse events (SAEs)(From baseline to 4 months)
- Safety - Number of participants who fall pregnant (WOCBP only)(Baseline to 4 months)
- Safety - Number of participants with significant changes to respiratory rate between groups(Baseline to 4 months)
- Serum lipid concentrations from baseline(From baseline to 4 months)
- Changes in HbA1c from baseline(From baseline to 4 months)
- Changes in serum malondialdehyde(From baseline to 4 months)
- Safety: Number of participants with changes to the gastrointestinal tract(Baseline to 4 months)
- Safety: Changes to characteristics in physical examination - musculoskeletal(Baseline to 4 months)
- Safety: Number of participants with changes to characteristics in skin appearance(Baseline to 4 months)
- Safety: Number of participants with clinically significant changes in biochemistry - creatinine(Baseline to 4 months)
- Safety: Number of participants with clinically significant changes in biochemistry - LD(Baseline to 4 months)
- Number of participants with changes to heart sounds(Baseline to 4 months)
- Number of participants with changes to respiratory effort(Baseline to 4 months)
- Safety: Number of participants with macroscopic abnormalities of the eyes(Baseline to 4 months)
- Safety: Number of participants with respiratory disease(Baseline to 4 months)
- Safety: Number of participants with clinically significant changes in biochemistry- ALT(Baseline to 4 months)
- Safety: Number of participants with clinically significant changes in biochemistry - urea(Baseline to 4 months)
- Safety: Number of participants with clinically significant changes in biochemistry - phosphate(Baseline to 4 months)
- Safety: Number of participants with clinically significant changes in biochemistry - albumin(Baseline to 4 months)
- Safety: Number of participants with clinically significant changes in haematology - RBC(Baseline to 4 months)
- Safety: Number of participants with clinically significant changes in haematology - MCHC(Baseline to 4 months)
- Safety: Number of participants with clinically significant changes in haematology - lymphocytes(Baseline to 4 months)
- Safety -Number of participants with visual symptoms(Baseline to 4 months)
- Safety: Number of participants with infections in the Ears, Nose, Mouth and Throat(Baseline to 4 months)
- Safety: Number of participants with clinically significant changes in biochemistry - ALP(Baseline to 4 months)
- Safety: Number of participants with clinically significant changes in biochemistry - urea nitrogen(Baseline to 4 months)
- Safety: Number of participants with clinically significant changes in biochemistry - potassium(Baseline to 4 months)
- Safety: Number of participants with clinically significant changes in biochemistry - chloride(Baseline to 4 months)
- Safety: Number of participants with clinically significant changes in biochemistry - CRP(Baseline to 4 months)
- Safety: Number of participants with clinically significant changes in biochemistry - uric acid(Baseline to 4 months)
- Safety: Number of participants with clinically significant changes in biochemistry - protein(Baseline to 4 months)
- Safety: Number of participants with changes to peripheral vascular function(Baseline to 4 months)
- Safety: Number of participants with clinically significant changes in biochemistry - GGT(Baseline to 4 months)
- Safety: Number of participants with clinically significant changes in biochemistry - creatinine kinase(Baseline to 4 months)
- Safety: Number of participants with clinically significant changes in biochemistry - glucose(Baseline to 4 months)
- Safety: Number of participants with clinically significant changes in haematology - RDW(Baseline to 4 months)
- Safety: Number of participants with clinically significant changes in haematology - PCV(Baseline to 4 months)
- Safety: Number of participants with clinically significant changes in haematology - platelets(Baseline to 4 months)
- Safety: Number of participants with clinically significant changes in haematology - white cell count (WCC)(Baseline to 4 months)
- Safety: Number of participants with clinically significant changes in biochemistry - sodium(Baseline to 4 months)
- Safety: Number of participants with clinically significant changes in biochemistry - calcium(Baseline to 4 months)
- Safety: Number of participants with clinically significant changes in biochemistry - globulins(Baseline to 4 months)
- Safety: Number of participants with clinically significant changes in haematology - haemoglobin(Baseline to 4 months)
- Safety: Number of participants with clinically significant changes in haematology - MCV(Baseline to 4 months)
- Safety: Number of participants with clinically significant changes in haematology - eosinophils(Baseline to 4 months)
- Safety: Number of participants with clinically significant changes in biochemistry - bicarbonate(Baseline to 4 months)
- Safety: Number of participants with clinically significant changes in biochemistry - total bilirubin(Baseline to 4 months)
- Safety: Number of participants with clinically significant changes in haematology - basophils(Baseline to 4 months)
- Safety: Number of participants with clinically significant changes in haematology - monocytes(Baseline to 4 months)
- Safety: Number of participants with clinically significant changes in haematology - neutrophils(Baseline to 4 months)
Investigators
Study Sites (2)
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