Hypercholesterolemia Clinical Trial
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
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.
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