None listed
Conditions
Brief summary
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.
Interventions
The aim of this study is to assess the effectiveness of Almega PL on improving blood markers associated with cardiac disease. The investigational product is a commercially available capsule-form herbal supplement containing 1g Almega PL: includes 250mg EPA, 120mg Polyphenols and 30mg of chlorophyll.
The investigational product is a commercially available capsule-form herbal supplement containing eicosapentaenoic acid (EPA) derived from microalgae. EPA is a type of omega-3 essential fatty acid
The aim of this study is to assess the effectiveness of Almega PL on improving blood markers associated with cardiac disease. The investigational product is a commercially available capsule-form herbal supplement containing 1g Almega PL: includes 250mg EPA, 120mg Polyphenols and 30mg of chlorophyll. The investigational product is a commercially available capsule-form herbal supplement containing eicosapentaenoic acid (EPA) derived from microalgae. EPA is a type of omega-3 essential fatty acid known to play a beneficial role in protection against cardiovascular disease. Participants will be asked to take the allocated product daily at a dosage of 1 capsule of Almega PL orally with water at breakfast. In addition, participants will be asked to attend the study site at week 6 for a follow up, skin prick test, blood test and completion of questionnaires. At the completion of the study (month 3), an assessment identical to what was undertaken at baseline will be carried out. Participants will be asked to maintain their usual level of physical activity and diet for the duration of the study. Changes in diet will be assessed by an accredited practising dietitian and changes in amount of exercise will be evaluated by an accredited exercise physiologist at the completion of the study.
Sponsors
RDC Global Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
25 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• 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
Exclusion criteria
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
Outcome results
None listed