Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001061729
Ethics application status
Approved
Date submitted
20/07/2022
Date registered
29/07/2022
Date last updated
2/10/2023
Date data sharing statement initially provided
29/07/2022
Date results information initially provided
2/10/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of a marine extract in healthy middle-aged women
Scientific title
Effect of a marine extract on body composition and strength in healthy middle-aged women using an open-label design
Secondary ID [1] 307478 0
NIL
Universal Trial Number (UTN)
U1111-1280-0233
Trial acronym
Linked study record
The current study is an open-label extension trial of the intervention planned in ACTRN12621000072819

Health condition
Health condition(s) or problem(s) studied:
Body composition 326870 0
Muscular strength 326871 0
Condition category
Condition code
Musculoskeletal 324081 324081 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 26 weeks
Adherence will be done via capsule count and also by checking the level of red blood cell fatty acids
Approximately half of participants will have a dual X-ray absorptiometry scan - selection will be voluntary stratified into two groups, pre-menopausal and post-menopausal.
Intervention code [1] 323929 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331880 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] 331880 0
Baseline, and 12 weeks and 26 weeks post commencement of intervention. Primary timepoint will be 12 weeks.
Secondary outcome [1] 411486 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] 411486 0
Baseline, 12 weeks and 20 weeks post commencement of intervention.
Secondary outcome [2] 411487 0
Lower body muscular strength is assessed by timed 5-second sit-and-stand test, as well as 30second and 6osecond STS for muscle endurance and power.
Timepoint [2] 411487 0
Baseline, 12 weeks and 20 weeks post commencement of intervention.
Secondary outcome [3] 411488 0

Red blood cell (RBC) fatty acid analysis for Omega-3 Index
Timepoint [3] 411488 0
Baseline, 12 weeks and 20 weeks post commencement of intervention.
Secondary outcome [4] 411489 0
In approximately 50% of trial participants, dual-energy X-Ray (DXA) - body composition - fat free mass, adipose tissue, bone mineral density, body volume.
Timepoint [4] 411489 0
Intervention period is now 20 weeks. This change as made after we recruited 5 participants.
Secondary outcome [5] 412135 0
Muscular strength assessed by grip strength (Jamar dynamometer)
Timepoint [5] 412135 0
Baseline, 12 weeks and 20 weeks post commencement of intervention.
Secondary outcome [6] 412136 0
Muscular strength assessed by 60-second sit-and-stand test,
Timepoint [6] 412136 0
Baseline, 12 weeks and 20 weeks post commencement of intervention.
Secondary outcome [7] 412137 0
Muscular power assessed by 30-second sit-and-stand test,
Timepoint [7] 412137 0
Baseline, 12 weeks and 20 weeks post commencement of intervention.
Secondary outcome [8] 412139 0
Composite blood inflammatory markers - tumor necrosis factor - alpha, high sensitivity CRP, interleukin-IL-6
Timepoint [8] 412139 0
Baseline, 12 weeks and 20 weeks post commencement of intervention.

Eligibility
Key inclusion criteria
Pre- and post menopausal women
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
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Women with osteoporosis
Peri-menopausal women
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
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
29/08/2022
Actual
1/05/2023
Date of last participant enrolment
Anticipated
3/10/2022
Actual
25/07/2023
Date of last data collection
Anticipated
12/12/2023
Actual
Sample size
Target
60
Accrual to date
Final
61
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 37953 0
2478 - Ballina
Recruitment postcode(s) [2] 37952 0
2480 - Lismore

Funding & Sponsors
Funding source category [1] 311756 0
Commercial sector/Industry
Name [1] 311756 0
Ki-Whole Enterprises Pty Ltd in conjunction with Pharmalink International Ltd
Country [1] 311756 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] 313217 0
None
Name [1] 313217 0
Address [1] 313217 0
Country [1] 313217 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311199 0
Southern Cross University Human Research Ethics Committee (SCU HREC)
Ethics committee address [1] 311199 0
Southern Cross University PO Box 157 Lismore NSW 2480 Australia
Ethics committee country [1] 311199 0
Australia
Date submitted for ethics approval [1] 311199 0
12/03/2023
Approval date [1] 311199 0
24/03/2023
Ethics approval number [1] 311199 0

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 an open-label trial in middle-aged healthy women (without osteoarthritis) to determine if improvements in body composition and strength can be determined.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120298 0
Mr Christopher Oliver
Address 120298 0
Z246 Southern Cross University Rifle Range Rd Lismore NSW 2480
Country 120298 0
Australia
Phone 120298 0
+61 418649676
Fax 120298 0
Email 120298 0
coliver@scu.edu.au
Contact person for public queries
Name 120299 0
Mr Christopher Oliver
Address 120299 0
Z251 Southern Cross University Rifle Range Rd Lismore NSW 2480
Country 120299 0
Australia
Phone 120299 0
+61 418649676
Fax 120299 0
Email 120299 0
coliver@scu.edu.au
Contact person for scientific queries
Name 120300 0
Mr Christopher Oliver
Address 120300 0
Z246 Southern Cross University Rifle Range Rd Lismore NSW 2480
Country 120300 0
Australia
Phone 120300 0
+61 418649676
Fax 120300 0
Email 120300 0
coliver@scu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
At this point trial sponsors not willing


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.