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.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04998695 -
Health Effects of Consuming Olive Pomace Oil
|
N/A | |
| Recruiting |
NCT03947866 -
Ezetimibe-Rosuvastatin Evaluation Study
|
||
| Completed |
NCT01709513 -
Study of Alirocumab (REGN727/SAR236553) in Patients With Primary Hypercholesterolemia and Moderate, High, or Very High Cardiovascular (CV) Risk, Who Are Intolerant to Statins (ODYSSEY ALTERNATIVE)
|
Phase 3 | |
| Completed |
NCT01212900 -
Randomized Trial of Imaging Versus Risk Factor-Based Therapy for Plaque Regression
|
Phase 4 | |
| Completed |
NCT00001154 -
Lipoprotein Metabolism in Normal Volunteers and Patients With High Levels of Lipoproteins
|
||
| Completed |
NCT02550288 -
A Clinical Trial to Assess the Efficacy and Safety of MK-0653C in Japanese Participants With Hypercholesterolemia (MK-0653C-383)
|
Phase 3 | |
| Completed |
NCT03929198 -
Translation of Pritikin Program to the Community
|
N/A | |
| Completed |
NCT04485793 -
Effect of a Dietary Supplement on Lipid Pattern and Liver Parameters in Hypercholesterolemia
|
N/A | |
| Completed |
NCT02341924 -
Validating the "Foods for Health" Portfolio of Functional Food Products
|
N/A | |
| Active, not recruiting |
NCT02223793 -
Vascular Lifestyle-Intervention and Screening in Pharmacy
|
N/A | |
| Completed |
NCT01941836 -
Evaluation of ETC-1002, Ezetimibe, and the Combination in Hypercholesterolemic Patients
|
Phase 2 | |
| Completed |
NCT01934608 -
The Effect of Synching Prescription Refills on Adherence
|
N/A | |
| Recruiting |
NCT01705873 -
Analysis on the Risk of Cardiovascular Events in HIV- Infected Subjects Treated With LPV/r Based HAART Regimen vs. an EFV Based Regimen
|
N/A | |
| Completed |
NCT01678521 -
Effect of LDL-apheresis on PTX3 Plasma Levels in Hypercholesterolemic Patients
|
N/A | |
| Completed |
NCT01670734 -
Pharmacokinetic and Tolerability of Alirocumab SAR236553 (REGN727) in Patients With Hepatic Impairment and in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT01370603 -
A Study to Evaluate the Effectiveness of Ezetimibe/Atorvastatin 10 mg/40 mg Combination Tablet Compared to Marketed Ezetimibe 10 mg and Atorvastatin 40 mg Tablets in Participants With High Cholesterol (MK-0653C-190 AM1)
|
Phase 3 | |
| Completed |
NCT01370590 -
A Study to Evaluate the Effectiveness of Ezetimibe/Atorvastatin 10 mg/20 mg Combination Tablet Compared to Marketed Ezetimibe 10 mg and Atorvastatin 20 mg Tablets in Participants With High Cholesterol (MK-0653C-185 AM1)
|
Phase 3 | |
| Completed |
NCT01446679 -
Special Drug Use-Results Survey of Lipitor Tablets
|
N/A | |
| Completed |
NCT01478789 -
Efficacy of Plant Sterol-Fortified Dairy Product on Plasma Lipid and Plant Sterol Concentrations in Humans
|
N/A | |
| Completed |
NCT01768403 -
Centralised Pan-Algerian Survey on the Undertreatment of Hypercholesterolemia
|
N/A |