Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001645842p
Ethics application status
Submitted, not yet approved
Date submitted
9/11/2021
Date registered
30/11/2021
Date last updated
30/11/2021
Date data sharing statement initially provided
30/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Seaweed extract, Fucoidan, as a supplement to support the development of muscle strength and function in sedentary individuals
Scientific title
Efficacy of Fucoidan as a supplement for development of muscle strength and function in an adult sedentary population: A double blind randomized parallel trial
Secondary ID [1] 305762 0
nil known
Universal Trial Number (UTN)
U1111-1271-3658
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
skeletal muscle health 324262 0
Condition category
Condition code
Musculoskeletal 321758 321758 0 0
Normal musculoskeletal and cartilage development and function
Alternative and Complementary Medicine 321759 321759 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A double blind randomized parallel trial, placebo controlled study will be conducted in which male and female subjects who achieve less than an estimated 1000 kcal/week activity threshold, will supplement their normal daily lives with either Fucoidan (500mg oral tablets, twice daily), or placebo (gelatin filled oral tablets, twice daily), for 6 weeks.

Prior to and after the 6 week supplement period, participants will have a strength assessment conducted at La Trobe University strength and conditioning gym (Bendigo campus), supervised by qualified exercise physiologists. These 2 sessions will involve a health screen, DEXA analysis of body composition, 1 rep max (1RM) back squat strength test and an anaerobic capacity Wingate test. This will require a session time for each participant of 60 min, a total of 2 hours.

To monitor adherence, we will be monitoring returned pill counts and activity journals provided by the participants.
Intervention code [1] 322163 0
Lifestyle
Intervention code [2] 322164 0
Treatment: Other
Comparator / control treatment
Participants assigned to the control/placebo intervention group will receive gelatin filled, oral tablet, twice daily, for 6 weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 329507 0
Change in muscle strength as determined by weight (in kgs) performed on the 1 rep maximum back squat
Timepoint [1] 329507 0
6 weeks post-intervention commencement
Primary outcome [2] 329508 0
Changes in body composition (measured by DEXA) including fat, lean muscle and bone density.
Timepoint [2] 329508 0
6 weeks post-intervention commencement
Primary outcome [3] 329509 0
Changes in anaerobic performance as determined by peak power (Watts per kg body weight) performed on the Wingate anaerobic fitness test
Timepoint [3] 329509 0
6 weeks post-intervention commencement
Secondary outcome [1] 402800 0
Change in blood pressure as determined by changes to arterial stiffness (mmHg) as measured by tonometry applanation
Timepoint [1] 402800 0
6 weeks post-intervention commencement

Eligibility
Key inclusion criteria
1) Adults between the age of 18-50
2) Less than estimated 1000 kcal/week activity threshold
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) Currently have any injuries or medical conditions that prohibit assessment of a 1 rep max back squat assessment
2) Have a history of medical conditions significantly effecting the cardiovascular system
3) Are pregnant

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)
Numbers 1-40 will be placed in an envelope. Upon enrolment in the trial, an envelope will be randomly selected and given to the individual. Prior to this, a random sequence of the numbers 1-40 will be generated, with odd numbers (in the sequence) being placebo and even numbers (in the sequence) being fucoidan.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. https://www.random.org/sequences/)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving 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
Sample size are based on pre-clinical animal and in vitro studies to estimate sample size based on the outcome of change in muscle mass and strength, using a paired samples one-tailed t-test with alpha 0.05 and 80% power

Statistical methods for analysing primary and secondary outcomes will be a general linear estimating model.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/03/2022
Actual
Date of last participant enrolment
Anticipated
11/07/2022
Actual
Date of last data collection
Anticipated
29/08/2022
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 35916 0
3550 - Bendigo

Funding & Sponsors
Funding source category [1] 310121 0
Commercial sector/Industry
Name [1] 310121 0
Marinova Pty Ltd
Country [1] 310121 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
La Trobe University
Plenty Rd & Kingsbury Drive,
Bundoora
Melbourne Victoria 3086
Australia
Country
Australia
Secondary sponsor category [1] 311187 0
Commercial sector/Industry
Name [1] 311187 0
Marinova Pty Ltd
Address [1] 311187 0
249 Kennedy Drive
Cambridge TAS 7170
Country [1] 311187 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 309809 0
La Trobe University Human Research Ethics Committee
Ethics committee address [1] 309809 0
Ethics committee country [1] 309809 0
Australia
Date submitted for ethics approval [1] 309809 0
15/11/2021
Approval date [1] 309809 0
Ethics approval number [1] 309809 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 115462 0
Dr Chris van der Poel
Address 115462 0
Department of Physiology, Anatomy & Microbiology
Health Sciences 2
La Trobe University
Plenty Rd & Kingsbury Dr,
Bundoora
Melbourne Victoria 3086
Australia
Country 115462 0
Australia
Phone 115462 0
+61 3 94795166
Fax 115462 0
Email 115462 0
[email protected]
Contact person for public queries
Name 115463 0
Chris van der Poel
Address 115463 0
Department of Physiology, Anatomy & Microbiology
Health Sciences 2
La Trobe University
Plenty Rd & Kingsbury Dr,
Bundoora
Melbourne Victoria 3086
Australia
Country 115463 0
Australia
Phone 115463 0
+61 3 94795166
Fax 115463 0
Email 115463 0
[email protected]
Contact person for scientific queries
Name 115464 0
Chris van der Poel
Address 115464 0
Department of Physiology, Anatomy & Microbiology
Health Sciences 2
La Trobe University
Plenty Rd & Kingsbury Dr,
Bundoora
Melbourne Victoria 3086
Australia
Country 115464 0
Australia
Phone 115464 0
+61 3 94795166
Fax 115464 0
Email 115464 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
After de-identification, all of the individual participant data collected during the trial will be shared
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
any purpose
How or where can data be obtained?
access subject to approvals by Principal Investigator (Chris van der Poel, [email protected])


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.