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Trial registered on ANZCTR


Registration number
ACTRN12618000275268
Ethics application status
Approved
Date submitted
13/02/2018
Date registered
22/02/2018
Date last updated
19/11/2020
Date data sharing statement initially provided
8/11/2018
Date results information initially provided
19/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
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.
Scientific title
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.
Secondary ID [1] 294042 0
ALM-CVH18
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardio-metabolic paramenters 306585 0
Condition category
Condition code
Cardiovascular 305679 305679 0 0
Coronary heart disease
Metabolic and Endocrine 305801 305801 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 300310 0
Treatment: Other
Comparator / control treatment
The placebo product is soy oil housed in an opaque gel capsule such to appear identical to the test product.
Control group
Placebo

Outcomes
Primary outcome [1] 304772 0
Omega 3 index via whole blood analysis
Timepoint [1] 304772 0
Baseline, Week 6 and Week 12
Secondary outcome [1] 343113 0
serum triglycerides
Timepoint [1] 343113 0
Baseline, Week 6 and Week 12
Secondary outcome [2] 343114 0
serum lipid profile including LDL-C, HDL-C, LDL/HDL-C ratio and non-HDL-C
Timepoint [2] 343114 0
Baseline, Week 6 and Week 12
Secondary outcome [3] 343115 0
Blood pressure measured by a study investigator using an automated blood pressure monitor
Timepoint [3] 343115 0
Baseline, Week 6 and Week 12
Secondary outcome [4] 343116 0
Omega 3:6 ratio using finger prick test
Timepoint [4] 343116 0
Baseline, Week 6 and Week 12
Secondary outcome [5] 343117 0
hs-CRP inflammation marker measured by serum assay
Timepoint [5] 343117 0
Baseline, Week 6 and Week 12
Secondary outcome [6] 343118 0
TNF-a marker of inflammation measured by serum assay
Timepoint [6] 343118 0
Baseline, Week 6 and Week 12
Secondary outcome [7] 343119 0
IL-6 marker of inflammation measured by serum assay
Timepoint [7] 343119 0
Baseline, Week 6 and Week 12
Secondary outcome [8] 343120 0
Homocysteine marker of oxidative stress measured by serum assay
Timepoint [8] 343120 0
Baseline, Week 6 and Week 12
Secondary outcome [9] 343121 0
Glutathione marker of inflammation measured by serum assay
Timepoint [9] 343121 0
Baseline, Week 6 and Week 12
Secondary outcome [10] 343122 0
MDA marker of oxidative stress measured by serum assay
Timepoint [10] 343122 0
Baseline, Week 6 and Week 12
Secondary outcome [11] 343123 0
ROS as a marker of oxidative stress measured by serum assay
Timepoint [11] 343123 0
Baseline, Week 6 and Week 12
Secondary outcome [12] 343124 0
body weight measured using scales
Timepoint [12] 343124 0
Baseline and Week 12
Secondary outcome [13] 343125 0
Safety assessed by liver function test measured via serum assay - AST, ALT, GGT, Bilirubin and Full blood count
Timepoint [13] 343125 0
Baseline and Week 12
Secondary outcome [14] 343126 0
Safety assessed by kidney function as measured by serum assay creatine/eGFR
Timepoint [14] 343126 0
Baseline and Week 12
Secondary outcome [15] 343127 0
Food intake as measured by food frequency questionnaire and/or food diary
Timepoint [15] 343127 0
Baseline and Week 12
Secondary outcome [16] 343128 0
Mood as assessed by Profile of Mood States or PANAS
Timepoint [16] 343128 0
Baseline, Week 4, Week 8 and Week 12
Secondary outcome [17] 343129 0
Sleep quality as assessed by Pittsburgh Sleep Index
Timepoint [17] 343129 0
Baseline, Week 4, Week 8 and Week 12
Secondary outcome [18] 343130 0
Fatigue as assessed by Multidimensional Symptoms Fatigue Index
Timepoint [18] 343130 0
Baseline, Week 4, Week 8 and Week 12
Secondary outcome [19] 343132 0
Quality of Life as assessed by SF-36
Timepoint [19] 343132 0
Baseline, Week 4, Week 8 and Week 12
Secondary outcome [20] 343415 0
Waist hip ratio measured using a tapemeasure
Timepoint [20] 343415 0
Baseline and Week 12
Secondary outcome [21] 343416 0
Body mass index measured using scales and a height measuring rod
Timepoint [21] 343416 0
Baseline and Week 12

Eligibility
Key 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
Minimum age
25 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The potential participants are screened by the investigator for inclusion in the study. The eligible participants are enrolled by investigator and provided with a "Numbered Container" that is identical to all other containers and contains the same information on the label, except for the number. The investigator is blinded to the product randomized with the
numbered containers labelled prior to delivery to investigational site. Product allocated as participants are enrolled in sequential order
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer randomized software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 298667 0
Commercial sector/Industry
Name [1] 298667 0
Qualitas Health
Address [1] 298667 0
E., 421 Imperial St, Imperial, TX 79743, United States
Country [1] 298667 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
RDC Global Pty Ltd
Address
3B/76 Doggett Street
Newstead, QLD, 4006
Country
Australia
Secondary sponsor category [1] 297835 0
Commercial sector/Industry
Name [1] 297835 0
Qualitas Health
Address [1] 297835 0
E., 421 Imperial St, Imperial, TX 79743, United States
Country [1] 297835 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299621 0
Bellberry Human Research Ethics Committee A Committee A (TGA HREC Code EC00372)
Ethics committee address [1] 299621 0
129 Glen Osmond Road
Eastwood South Australia 5063
Ethics committee country [1] 299621 0
Australia
Date submitted for ethics approval [1] 299621 0
05/12/2017
Approval date [1] 299621 0
03/04/2018
Ethics approval number [1] 299621 0
2017-12-916-A-4

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81062 0
Dr David Briskey
Address 81062 0
RDC GLOBAL Pty Ltd
3B/76 Doggett Street, Newstead, QLD, 4006
Country 81062 0
Australia
Phone 81062 0
+61 421 784 077
Fax 81062 0
Email 81062 0
d.briskey@uq.edu.au
Contact person for public queries
Name 81063 0
Ms Amanda Rao
Address 81063 0
RDC GLOBAL Pty Ltd
3B/76 Doggett Street, Newstead, QLD, 4006
Country 81063 0
Australia
Phone 81063 0
+61 414 488 559
Fax 81063 0
Email 81063 0
amanda@rdcglobal.com.au
Contact person for scientific queries
Name 81064 0
Ms Amanda Rao
Address 81064 0
RDC GLOBAL Pty Ltd
3B/76 Doggett Street, Newstead, QLD, 4006
Country 81064 0
Australia
Phone 81064 0
+61 414 488 559
Fax 81064 0
Email 81064 0
amanda@rdcglobal.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD will not be made available. If the trial results are published, data will be used in an unidentifiable format.
What supporting documents are/will be available?
Ethical approval
How or where can supporting documents be obtained?
Type [1] 129 0
Ethical approval
Citation [1] 129 0
Link [1] 129 0
Email [1] 129 0
Other [1] 129 0
Type [2] 137 0
Ethical approval
Citation [2] 137 0
Link [2] 137 0
Email [2] 137 0
Other [2] 137 0
amendment 1 approval
Type [3] 138 0
Ethical approval
Citation [3] 138 0
Link [3] 138 0
Email [3] 138 0
Other [3] 138 0
amendment 2 approval
Type [4] 2673 0
Ethical approval
Citation [4] 2673 0
Link [4] 2673 0
Email [4] 2673 0
Other [4] 2673 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary