NCT04783714: CLoNE

Investigating Effects of a Novel Nutraceutical on Hypercholesterolaemia in Australian Adults

Completed NA Last updated 11 March 2022

What this trial tests

NA trial testing Swisse Nutra+ Cholesterol Balance in Hypercholesterolemia in 42 participants. Completed in 22 October 2021.

Timeline

30 April 2021

Primary endpoint
22 October 2021

22 October 2021

Quick facts

Lead sponsor	Swisse Wellness Pty Ltd
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	42
Start date	30 April 2021
Primary completion	22 October 2021
Estimated completion	22 October 2021
Sites	1 location across Australia

Drugs / interventions tested

• Swisse Nutra+ Cholesterol Balance
• Placebo

Conditions studied

• Hypercholesterolemia — all drugs for Hypercholesterolemia →

Sponsor

Swisse Wellness Pty Ltd

Who can join

Adults 18 to 65, any sex, with Hypercholesterolemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Polyphenols, the Healthy Brand of Olive Oil: Insights and Perspectives.
   Finicelli M, Squillaro T, Galderisi U, Peluso G. · · 2021 · cited 36× · PMID 34836087 · DOI 10.3390/nu13113831