Investigating Effects of a Novel Nutraceutical on Hypercholesterolaemia in Australian Adults
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional

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.
    


Intervention name(s): Swisse Nutra+ Cholesterol Balance; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 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.; Matched brown soft-gel capsule placebo containing olive oil and palm olein - no therapeutic benefit.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Treatment arm and Placebo arm
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: hypercholesterolemia; low-density lipoprotein; nutraceutical; bergamot; artichoke; phytosterols; hydroxytyrosol