Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12621000072819
Ethics application status
Approved
Date submitted
3/09/2020
Date registered
29/01/2021
Date last updated
21/07/2022
Date data sharing statement initially provided
29/01/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of a marine extract on body composition
Scientific title
Effect of a marine extract on body composition and strength in healthy middle-aged persons using a randomised, double-blinded design
Secondary ID [1] 302185 0
NONE
Universal Trial Number (UTN)
U1111-1257-8939
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Body composition 318851 0
Muscular strength 318852 0
Condition category
Condition code
Musculoskeletal 316855 316855 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Blend of two marine oils PCSO-524 (green-lipped mussel) and ESPO-572 (krill)
Two 200mg capsules will be taken orally twice daily for 10 weeks
Adherence will be done via capsule count and also by checking the level of RBC fatty acids
Intervention code [1] 318484 0
Treatment: Other
Comparator / control treatment
The comparator will be a non-active substance identical in shape and colour to active and the marine oil will be replaced by a slightly higher amount of the carrier oil i.e. olive oil
Control group
Placebo

Outcomes
Primary outcome [1] 324964 0
Body composition measured by multi-frequency bioelectrical impedance - Tanita MC980. Body composition measurements will include fat free mass, muscle mass, body fat, total body water, extracellular water, as well as resistance and reactance
Timepoint [1] 324964 0
Baseline and 10 weeks post commencement of intervention.
Secondary outcome [1] 386369 0
3D optical scanning - body morphology which includes numerous body circumferences e.g. waist, neck, midarm, thigh and calf, as well as numerous body component lengths e.g. arm.
Timepoint [1] 386369 0
Baseline and 10 weeks post commencement of intervention.
Secondary outcome [2] 386370 0
Muscular strength assessed by multiple separate outcomes i.e. grip strength (Jamar dynamometer), timed 10-second sit-and-stand, 60-second sit-and-stand test, as well as a composite score of the above.
Timepoint [2] 386370 0
Baseline and 10 weeks post commencement of intervention.
Secondary outcome [3] 386371 0
Red blood cell (RBC) fatty acid analysis for Omega-3 Index
Timepoint [3] 386371 0
Baseline and 10 weeks post commencement of intervention.
Secondary outcome [4] 386484 0
Dual-energy X-Ray (DXA) - body composition - fat free mass, adipose tissue, bone mineral density, body volume.
Timepoint [4] 386484 0
Baseline and 10 weeks post commencement of intervention.

Eligibility
Key inclusion criteria
Not physically or mentally impacted by a severe acute or chronic medical condition
Persons with Type 2 diabetes, well-controlled with or without medication, for greater than six months, will be eligible
Persons on stable blood pressure or lipid medication for greater than three months will be eligible as long there is no diagnosis of a major cardiovascular disease.
BMI greater than 18 and less than 35
Minimum age
40 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Having a pacemaker or other metallic implants
Smokers, including vaping
Allergy to shellfish, green-lipped mussels or Antarctic krill
Pregnant or breast-feeding or planning to become pregnant in the next 6 months.
Alcohol or drug addiction.
Inability to cease taking current alternative medicines for the duration of the trial.
Persons with kidney disease or impaired kidney function
Persons with oedema
Persons with severe vertigo

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)
Allocation involved contacting the holder of the allocation schedule who was “off-site” or at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
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
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Minimum sample size was calculated on the effect seen in preliminary trials when current primary endpoint was measured as a secondary endpoint. Additional numbers were added to a) allow for dropouts (~20%) and b) to obtain a larger representative sample in a healthy population

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2023
Actual
Date of last participant enrolment
Anticipated
1/07/2023
Actual
Date of last data collection
Anticipated
1/03/2024
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 31148 0
2480 - Lismore

Funding & Sponsors
Funding source category [1] 306606 0
Commercial sector/Industry
Name [1] 306606 0
Ki-Whole Enterprises Pty Ltd in conjunction with Pharmalink International Ltd
Country [1] 306606 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Pharmalink International Pty Ltd
Address
c/o Third Floor
31C-D Wyndam Street
Central, Hong Kong
Country
Hong Kong
Secondary sponsor category [1] 307138 0
None
Name [1] 307138 0
Address [1] 307138 0
Country [1] 307138 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306791 0
Southern Cross University Human Research Ethics Committee (SCU HREC)
Ethics committee address [1] 306791 0
Southern Cross University
PO Box 157
Lismore NSW 2480
Australia
Ethics committee country [1] 306791 0
Australia
Date submitted for ethics approval [1] 306791 0
22/07/2020
Approval date [1] 306791 0
30/08/2020
Ethics approval number [1] 306791 0
2020/117

Summary
Brief summary
With the general ageing of the population attributed to Baby Boomers and the increase in life expectancy, attention of health consumers is turning from simply the treatment of chronic illness to increasing the span of good health (healthspan) as people age.
The inflamma-ageing hypothesis proposes that much of the ageing process per se as well as chronic disease, even in healthy persons, is underpinned by chronic low-level inflammation.
In pilot human studies undertaken by NatMed Research looking at their proprietary green-lipped mussel-based products as an anti-inflammatory treatment of osteoarthritis, the observation was made of changes in body composition in those persons receiving active medication.
The current proposal is to undertake a randomised controlled trial in middle-aged healthy study population (without osteoarthritis) to determine if improvements in body composition and strength can be determined under double-blind conditions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 105038 0
Mr Christopher Oliver
Address 105038 0
Z251 Southern Cross University Rifle Range Rd Lismore NSW 2480
Country 105038 0
Australia
Phone 105038 0
+61 418649676
Fax 105038 0
Email 105038 0
[email protected]
Contact person for public queries
Name 105039 0
Mr Christopher Oliver
Address 105039 0
Z251 Southern Cross University Rifle Range Rd Lismore NSW 2480
Country 105039 0
Australia
Phone 105039 0
+61 418649676
Fax 105039 0
Email 105039 0
[email protected]
Contact person for scientific queries
Name 105040 0
Mr Christopher Oliver
Address 105040 0
Z251 Southern Cross University Rifle Range Rd Lismore NSW 2480
Country 105040 0
Australia
Phone 105040 0
+61 418649676
Fax 105040 0
Email 105040 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Decision of sponsor


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.