Ignite Creation Date:
2024-05-06 @ 3:51 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04783714
Status:
COMPLETED
Last Update Posted:
2022-03-11
First Post:
2021-02-11
Brief Title:
Investigating Effects of a Novel Nutraceutical on Hypercholesterolaemia in Australian Adults
Sponsor:
Swisse Wellness Pty Ltd
Organization:
Swisse Wellness Pty Ltd
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CLoNE
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 25mmolL and 5 mmolL 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
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 25mmolL and 5 mmolL 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None