A double-blind, randomised, placebo-controlled interventional study to evaluate the effect of orally-dosed Almega PL on cardio-metabolic parameters and inflammatory markers in men and women.
- Conditions
- Cardio-metabolic paramentersCardiovascular - Coronary heart diseaseMetabolic and Endocrine - Other metabolic disorders
- Registration Number
- ACTRN12618000275268
- Lead Sponsor
- RDC Global Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 122
•Males and females over 25 years
•Otherwise healthy, BMI 18.5-39.9
•Able to provide informed consent
•Omega 6:3 ratio above 6:1
Unstable or serious illness (eg kidney, liver, GIT, heart conditions and diabetes)
Hypercholesterolemia >7 mmol/L (193-270 mg/dL).(Will be referred to GP).
Malignancy or treatment for malignancy within the previous 2 years
Receiving/prescribed coumandin (Warfarin), heparin, daltaparin, enoxaparin or other
anticoagulation therapy
Pregnancy or lactating women
Active smokers
Chronic past and/or current alcohol use (>14 alcoholic drinks per week)
Allergic to any of the ingredients in active or placebo formula
Serious mood disorders (such as depression and bipolar disorder) will be excluded. The
Hamilton Rating Scale for Depression will be used as a screening form to ensure that those
with undiagnosed depression are not enrolled into the study.
Any condition which in the opinion of the investigator makes the participant unsuitable for
inclusion
Participants who have participated in any other clinical trial during the past month
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Omega 3 index via whole blood analysis [Baseline, Week 6 and Week 12 ]
- Secondary Outcome Measures
Name Time Method