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Trial registered on ANZCTR


Registration number
ACTRN12621000413820
Ethics application status
Approved
Date submitted
17/02/2021
Date registered
15/04/2021
Date last updated
15/08/2023
Date data sharing statement initially provided
15/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Mussel with fucoidan as a supplemented superfood for adults with prediabetes and joint pain
Scientific title
Investigating the efficacy of combining mussel with fucoidan as a supplement on insulin resistance and joint pain outcomes in adults of Chinese ethnicity
Secondary ID [1] 303485 0
None
Universal Trial Number (UTN)
U1111-1254-4149
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
prediabetes 320803 0
joint pain 320804 0
Condition category
Condition code
Metabolic and Endocrine 318625 318625 0 0
Diabetes
Musculoskeletal 318626 318626 0 0
Other muscular and skeletal disorders
Anaesthesiology 318958 318958 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The mussel-fucoidan prototype product will be 20 g of dark chocolate which contains 1000 mg of mussel powder and 1000 mg of fucoidan extract.
The prototype product will contain 109 calories, while the placebo will contain 118 calories. Participants in both the treatment intervention and placebo groups will be advised to substitute foods with an equivalent caloric value with this dark chocolate product to maintain a similar caloric intake (e.g. minimise cooking oil used, replace usual snack with dark chocolate product).
Each participant will take a 20 g chocolate bar each day for 100 days. Participants all have prediabetes and joint pain conditions.
Used and unused packets will be collected at the end of the trial to monitor the compliance of the intervention.
Intervention code [1] 319776 0
Prevention
Intervention code [2] 319777 0
Treatment: Other
Comparator / control treatment
The placebo will be 20g of dark chocolate and will not contain any active substances but with the same flavour of treatment product.
Control group
Placebo

Outcomes
Primary outcome [1] 326582 0
Blood serum samples will be used to measure insulin and glucose and insulin resistance, defined by the homeostasis model of assessment (HOMA) values, will be derived those measurements.
Timepoint [1] 326582 0
Baseline (day 0), and 100 days after the trial starting date
Primary outcome [2] 326583 0
Change in Joint pain measured by Western Ontario and McMaster Universities Arthritis (WOMAC) Index pain subscale-B (WOMAC-B)
Timepoint [2] 326583 0
Baseline (day 0) and 100 days after the trial starting date
Secondary outcome [1] 391978 0
change in anthropometry measured by stadiometer, digital scale, pelvimeter and calipers
Timepoint [1] 391978 0
Baseline (Day 0) and 100 days after the trial starting date
Secondary outcome [2] 391979 0
This outcome has been removed due to practicality. Patients can't stay for 2 hours.
Timepoint [2] 391979 0
Baseline (Day 0) and 100 days after the trial starting date
Secondary outcome [3] 391980 0
Change in composite glucoregulatory markers (glucose, insulin, HbA1c), measured from blood serum samples.
Timepoint [3] 391980 0
Baseline (Day 0) and 100 days after the trial starting date
Secondary outcome [4] 391981 0
Change in inflammatory markers (C-reactive protein, tumour necrosis factor-alpha (TNF–a), interleukin (IL)-6, IL-2, IL-8, IL-1beta, IL-10 and IL-4) measured from blood serum samples.
Timepoint [4] 391981 0
Baseline (Day 0) and 100 days after the trial starting date
Secondary outcome [5] 391982 0
Change in pain on Visual Analogue Scale (VAS, 0=no pain, 10=worst imaginable pain)
Timepoint [5] 391982 0
Baseline (Day 0) and 100 days after the trial starting date
Secondary outcome [6] 391983 0
change in satiety on VAS (0=extremely hungry, 10=extremely full)
Timepoint [6] 391983 0
Baseline (Day 0) and 100 days after the trial starting date
Secondary outcome [7] 391984 0
change in analgesic medication use ( participant self-report diary)
Timepoint [7] 391984 0
Day 0 and 100 days after the trial starting date

Eligibility
Key inclusion criteria
Chinese participants with Prediabetes defined by recent HbA1c between 39-49 mmol/mol, and lasting knee or hip joint pain (e.g. hip or knee pain) for the last three months or longer
Minimum age
30 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Diabetes, Known or suspected seafood (fish and shellfish) allergy, Currently taking a green-lipped mussel supplement, Previous joint replacement surgery, or planning this within the next six months, Pregnant or breastfeeding, or intending to become pregnant within the next six months, Previous bariatric surgery, Conditions which may influence body weight regulation (e.g. malabsorption, thyroid disorders), Taking any glucose-lowering medications, systemic steroids, or blood thinners, Thalassemia, asthma, gout, liver disease, kidney disease, Planning major changes to physical activity within the next six months, Significant weight loss or weight gain within the last six months, Fear of needles or giving blood, and No access to a smartphone, tablet, or Internet.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Eligible participants will be randomly assigned to receive either the mussel-fucoidan prototype product or the placebo in a 1:1 ratio. The trial biostatistician will prepare the blinded random lists using permutated block randomisation with variable block sizes. The participant randomisation list will be labelled as group A or B. Random pack numbers will also be generated in the drug food labelling list and pre-packed in identical boxes by Alaron Products Limited. Once a participant has provided informed consent and confirmed eligible to be randomised, the database will show the pack number linked to the participant in the allocated group. A research assistant will provide participants with their correct treatment packs, with no information on actual group allocation. Neither the participant nor any member of the research team will know the treatment product indicated by the randomisation.
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A total sample size of 146 participants (73 per arm), will provide 90% power at 5% significance level (two-sided) to detect a group difference of 1cm on patient reported pain, and 0.5 unit change in HOMA at the end of food intervention, allowing for 10% loss to follow up. The standard deviation (SD) for change in HOMA is assumed to be 0.8 as reported in a previous study. This gives a standardised effect size of 0.625 (0.5/0.8). For pain reduction, we based our calculation on a recentpublished trial [15], where a SD of 1.6cm was reported for WOMAC-B. A minimum pain reduction of 1cm is considered clinically significant, which is equivalent to a standardised effect size of 0.625 same as the effect size for change in HOMA. Since we have two co-primary endpoints, this sample size has controlled for Bonferroni correction with a=0.025 for each outcome (overall type I error rate 0.05).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2021
Actual
1/02/2022
Date of last participant enrolment
Anticipated
15/12/2022
Actual
15/12/2022
Date of last data collection
Anticipated
31/03/2023
Actual
17/02/2023
Sample size
Target
150
Accrual to date
Final
146
Recruitment outside Australia
Country [1] 23470 0
New Zealand
State/province [1] 23470 0
Auckland

Funding & Sponsors
Funding source category [1] 307903 0
Government body
Name [1] 307903 0
National Science Challenge High Value Nutrition (Ministry of Business Innovation and Employment)
Country [1] 307903 0
New Zealand
Funding source category [2] 307908 0
Commercial sector/Industry
Name [2] 307908 0
Beyond Capital MedTech Management Ltd
Country [2] 307908 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
25a Princes St, Auckland CBD, Auckland 1010
Country
New Zealand
Secondary sponsor category [1] 308617 0
Commercial sector/Industry
Name [1] 308617 0
Beyond Capital MedTech Management Ltd
Address [1] 308617 0
Suite 18, Level One, 130 St. Georges Bay Road, Parnell, Auckland 1052
Country [1] 308617 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307900 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 307900 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 307900 0
New Zealand
Date submitted for ethics approval [1] 307900 0
01/09/2020
Approval date [1] 307900 0
19/11/2020
Ethics approval number [1] 307900 0
20STH153

Summary
Brief summary
Background: Inflammatory conditions such as chronic musculoskeletal joint pain and insulin resistance strongly contribute to the global burden of disease. Although pharmaceutical drugs are beneficial, the experienced side effects have led to the search for alternative therapies. One complementary therapy stems from Perna canaliculus, the New Zealand green-lipped mussel. Nutritional supplements with P. canaliculus extract have shown promise in placebo-controlled trials for inflammatory conditions. A waste product of the mussel harvest process is Undaria pinnatifida, a species of seaweed. Fucoidans can be extracted from U. pinnatifida and has anti-inflammatory properties, which can relieve joint pain. It can also inhibit starch hydrolysing enzymes and may be a potential anti-diabetic agent. Products containing fucoidan extracts are gaining interest, particularly in China. However, green-lipped mussel and fucoidan extracts have never been combined.
Methods: This is a parallel, two-arm, double-blind, randomised, placebo-controlled trial to be conducted in Auckland, New Zealand. We aim to establish whether a food product supplemented with green-lipped mussel and fucoidan extracts improves joint pain and/or insulin resistance. Participants who identify as Chinese, are aged over 30 years, and have prediabetes with joint pain will be eligible. They will consume either a food product supplemented with 1000 mg mussel powder and 1000 mg fucoidan extract or inert starch daily for 100 days. The primary endpoints are change in insulin resistance and patient-reported joint pain. Secondary outcomes include changes in anthropometry, fasting and postprandial glucose and insulin, HbA1c, inflammatory markers, satiety, and analgesic medication use. A sample size of 150 participants (75 per arm) will provide 90% power at an overall significance level of 5% (two-sided) to detect a standardised effect size of 0.625 on either of the two co-primary outcomes, allowing for 10% loss to follow-up.
Discussion: This trial will provide insight into mussel-fucoidan combinations and utilise a current waste product, adding value to the mussel industry. This trial will provide data on the potential utility of a mussel-fucoidan supplement in reducing joint pain and insulin resistance, to inform the development of a supplemented food product that is suitable for the Chinese market.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108874 0
Prof Jun Lu
Address 108874 0
Auckland Bioengineering Institute, University of Auckland.
Private Bag 92019, Auckland 1142
Country 108874 0
New Zealand
Phone 108874 0
+64 212644215
Fax 108874 0
Email 108874 0
[email protected]
Contact person for public queries
Name 108875 0
Jun Lu
Address 108875 0
Professor Jun Lu,
Auckland Bioengineering Institute,
University of Auckland.
Private Bag 92019, Auckland 1142
Country 108875 0
New Zealand
Phone 108875 0
+64 212644215
Fax 108875 0
Email 108875 0
[email protected]
Contact person for scientific queries
Name 108876 0
Jun Lu
Address 108876 0
Professor Jun Lu,
Auckland Bioengineering Institute,
University of Auckland.
Private Bag 92019, Auckland 1142
Country 108876 0
New Zealand
Phone 108876 0
+64 212644215
Fax 108876 0
Email 108876 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
Individual participant will not be identified.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10728Study protocol    381454-(Uploaded-17-02-2021-10-31-43)-Study-related document.docx
10729Ethical approval    381454-(Uploaded-17-02-2021-10-31-57)-Study-related document.pdf
10730Informed consent form    381454-(Uploaded-17-02-2021-10-32-47)-Study-related document.doc



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.