Investigating Effects of a Novel Nutraceutical on Hypercholesterolaemia in Australian Adults

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.

Conditions

• Hypercholesterolemia

Interventions

DIETARY_SUPPLEMENT

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.

DIETARY_SUPPLEMENT

Placebo

Matched brown soft-gel capsule placebo containing olive oil and palm olein - no therapeutic benefit.

Sponsors & Collaborators

• Commonwealth Scientific & Industrial Research Organisation

  collaborator OTHER

• BIONAP SRL

  collaborator UNKNOWN

• Swisse Wellness Pty Ltd

  lead INDUSTRY

Principal Investigators

• Welma Stonehouse, PhD · Commonwealth Scientific and Industrial Research Organisation, Australia

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-04-30

Primary Completion

2021-10-22

Completion

2021-10-22

Countries

• Australia

Study Locations