Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000872831
Ethics application status
Approved
Date submitted
21/05/2021
Date registered
6/07/2021
Date last updated
12/11/2021
Date data sharing statement initially provided
6/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Immunomodulatory effects of Fucoidan (seaweed extract) in recreationally active adults
Scientific title
A nutritional supplement study in recreationally active individuals to evaluate 3 weeks of supplementation with the seaweed extract Fucoidan on immune biomarkers: a randomised, double-blind, placebo controlled trial
Secondary ID [1] 304263 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Immune Competence 322013 0
Condition category
Condition code
Inflammatory and Immune System 319731 319731 0 0
Normal development and function of the immune system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Daily Fucoidan supplementation for 3 weeks (3 weeks washout period between phases). One capsule, twice daily in the morning and evening. The supplement composition is as follows: Undaria pinnatifida and Fucus vesiculosus extracts (Marinova, Tasmania, Australia) containing 75.5% fucoidan. Fuicodan or placebo supplementation will commence on the day of the first sprint trial of each block (session 1, day 1) and cease the day of the last trial (session 9, day ~19).

Dosage: 500mg

Route of administration: Oral

Strategies used to monitor adherence to the intervention: Return of capsule bottle at the end of the 3-week supplementation phase and a checklist at each testing session will be completed to ensure participants have taken the supplement each day.

Supervision: Lead researcher, two research assistants, and two undergraduate student helpers. All supervisors of the sessions have accreditation with ESSA, first aid, and CPR qualification and have completed the relevant lab inductions.

Mode of administration: Participants will complete the testing sessions in groups of five maximum (3 groups each testing day) together. The VO2 testing will be completed individually with supervision by two research assistants in a sports laboratory.

The intensity of testing: participants will be told to complete the 6-second sprints at maximal intensity (RPE 17-20)

Session frequency: Sessions are 3 times per week for 3 weeks (9 sessions in total) for each supplementation phase block. The sessions will take ~45 minutes for completion including a warm-up and the repeated sprint protocol.

Total duration of the program: 2 x 3-week blocks (6 weeks of exercise in total)
Program adherence monitoring: Attendance will be monitored for all sessions via a checklist completed upon participant arrival at the sessions.

Fitness Test (VO2): All participants will undertake an initial cycle-based VO2max test in the physiology laboratory at the University of Canberra to volitional exhaustion upon recruitment to the study. Results from the VO2max test will be used to determine workload intensities to employ during supervised training sessions.

Repeated Sprint Protocol: The repeated-sprint training protocol will consist of four sets of 5 × 6-s maximal (i.e., all-out and standing) cycling sprints separated by 24 s of passive recovery and 5 min of seated rest between sets (total time 30 min). The sprints will be conducted on the Wattbike ergometer at air and magnetic resistances of 10 and 3, respectively. A countdown to start and finish each sprint will be provided, as well as strong verbal encouragement.
Intervention code [1] 320600 0
Treatment: Other
Comparator / control treatment
Daily placebo supplementation for 3 weeks (3 weeks washout period between phases). One capsule, twice daily in the morning and evening. The placebo supplement composition is as follows: cellulose microcrystalline (Flocel 101).

Dosage: 500mg

Route of administration: Oral
Control group
Placebo

Outcomes
Primary outcome [1] 327595 0
Blood samples for routine haematology and biochemistry analysis, including full blood count with white cell differential, electrolytes, measures of liver and kidney function, blood lipids, and C-reactive protein. These collections and analyses will be outsourced to a local pathology provider.
Timepoint [1] 327595 0
Blood samples (~12 ml) will be collected within 24-48 h before the first repeated sprint testing session and 24-48 h after the last repeated sprint testing session of each supplementation phase (a total of four samples or ~48 ml over the entire study).
Primary outcome [2] 327596 0
Participants will be provided with a collection kit (consisting of flushable collection paper, collection cup with scooped lid and sealable specimen bag) and instructed to collect ~5g of faecal material during a routine bowel motion. Participants will be asked to return the sample to the laboratory within 24 h of collection; samples will be stored frozen at -80 °C until analysis. Faecal samples will be used for determination of calprotectin, lysozyme and sIgA concentrations using commercially available immunoassay kits.
Timepoint [2] 327596 0
Faecal samples will be collected by the participants at their homes (via a sample pack) and brought in at the first and last repeated sprint testing session of each supplementation phase (a total of four samples). Samples are then stored in a freezer until the end of the study for analysis.
Primary outcome [3] 327597 0
In addition, saliva samples will be collected before, immediate post, and 1h following a supervised exercise session during each of the supplementation phases. Saliva samples will be collected unstimulated using eye-spear absorbent swabs placed in the sublingual region until saturated. Eye-spear swabs will be placed in collection tubes and stored frozen at -80 °C until analysis. Saliva samples will be used for the determination of lactoferrin, lysozyme, and IgA concentrations using commercially available immunoassay kits.
Timepoint [3] 327597 0
Saliva samples (0.5-1mL) will be collected at the first testing session (baseline), 4th testing session (1.5 weeks post-intervention commencement), and the final repeated sprint testing session (3 weeks post-intervention commencement). 6 samples will be provided in total for the duration of the study.
Secondary outcome [1] 395851 0
During the repeated sprint testing sessions a number of measures will be recorded to track participants' performance and training adaptations during the 3 weeks supplementation blocks. One of these is the participant ratings of perceived exertion (RPE; Borg, 1982) which will be recorded at the end of each set of sprints. This is a scale 6-20, with 6 being at rest/no exertion and 20 indicating maximal exertion.
Timepoint [1] 395851 0
The secondary outcome of RPE [1] will be recorded at each repeated sprint testing session. Three sessions per week for 3 weeks for the 2 supplementation phases (18 sessions in total for the duration of the study). Outcomes will be recorded in either the morning, noon, or evening at a regular predetermined time for the participants.
Secondary outcome [2] 397926 0
During the repeated sprint testing, peak (W) and mean power output (W) will be recorded after each 6s sprint effort. After each sprint, the values are displayed on a summary screen on the watt bike and will be recorded by a research assistant before the next sprint repetition begins.
Timepoint [2] 397926 0
The secondary outcome of peak and mean power [2] will be recorded at each repeated sprint testing session. Three sessions per week for 3 weeks for the 2 supplementation phases (18 sessions in total for the duration of the study). Outcomes will be recorded in either the morning, noon, or evening at a regular predetermined time for the participants.
Secondary outcome [3] 397927 0
During the repeated sprint testing, heart rate (bpm) will be monitored continuously and recorded at the end of each 6s sec sprint effort. Heart rate will be monitored using a Garmin Bluetooth strap fitted around the chest of the participant and connected to a watch for visual display.
Timepoint [3] 397927 0
The secondary outcome of peak and mean power [3] will be recorded at each repeated sprint testing session. Three sessions per week for 3 weeks for the 2 supplementation phases (18 sessions in total for the duration of the study). Outcomes will be recorded in either the morning, noon, or evening at a regular predetermined time for the participants.

Eligibility
Key inclusion criteria
Be male;
Be aged between 18-45 years;
Have a 12 month history of regular physical activity of a minimum of 30 minutes of moderate intensity exercise per day, or the equivalent of 3.5 hours per week;
Minimum age
18 Years
Maximum age
45 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Have no history of gastrointestinal disease (IBD, IBS etc), asthma, diabetes,
renal disease, cardiovascular disease, arthritis or use immune-modulating medications

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/01/2022
Actual
Date of last participant enrolment
Anticipated
31/01/2022
Actual
Date of last data collection
Anticipated
29/04/2022
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT

Funding & Sponsors
Funding source category [1] 308641 0
Commercial sector/Industry
Name [1] 308641 0
Marinova Pty Ltd
Country [1] 308641 0
Australia
Primary sponsor type
University
Name
University of Canberra
Address
University of Canberra
11 Kirinari Street BRUCE ACT 2617
Country
Australia
Secondary sponsor category [1] 309516 0
University
Name [1] 309516 0
Griffith University
Address [1] 309516 0
Gold Coast Campus
Parklands Drive
Southport
QLD 4222
Country [1] 309516 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308567 0
University of Canberra Human Ethics Committee
Ethics committee address [1] 308567 0
Ethics committee country [1] 308567 0
Australia
Date submitted for ethics approval [1] 308567 0
08/04/2021
Approval date [1] 308567 0
30/04/2021
Ethics approval number [1] 308567 0
20217048

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

Contacts
Principal investigator
Name 111166 0
Prof David Pyne
Address 111166 0
Research Institute for Sport and Exercise
Building 29 Level C Room 43
University of Canberra
11 Kirinari Street BRUCE ACT 2617
Country 111166 0
Australia
Phone 111166 0
+61 0417 675 280
Fax 111166 0
Email 111166 0
[email protected]
Contact person for public queries
Name 111167 0
David Pyne
Address 111167 0
Research Institute for Sport and Exercise
Building 29 Level C Room 43
University of Canberra
11 Kirinari Street BRUCE ACT 2617
Country 111167 0
Australia
Phone 111167 0
+61 0417 675 280
Fax 111167 0
Email 111167 0
[email protected]
Contact person for scientific queries
Name 111168 0
Amanda Cox
Address 111168 0
Griffith University
G40_9.17, Parklands Drive, Southport, QLD, 4215
Country 111168 0
Australia
Phone 111168 0
+61 7 56780899
Fax 111168 0
Email 111168 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


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
SourceTitleYear of PublicationDOI
Dimensions AIImmunopotentiating Activity of Fucoidans and Relevance to Cancer Immunotherapy2023https://doi.org/10.3390/md21020128
N.B. These documents automatically identified may not have been verified by the study sponsor.