Mussel with fucoidan as a supplemented superfood for adults with prediabetes and joint pain

• Register: ANZCTR
• Last refreshed on: 21 August 2023
• Main ID: ACTRN12621000413820
• Date of registration: 15/04/2021
• Prospective Registration: Yes
• Primary sponsor: University of Auckland
• 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
• Date of first enrolment: 01/02/2022
• Target sample size: 150
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12621000413820.aspx
• Study type: Interventional
• Study design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

New Zealand

Contacts

• Name: Prof Jun Lu

• Name: Prof Jun Lu

Key inclusion & exclusion criteria

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
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.

Age minimum: 30 Years
Age maximum: 80 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

prediabetes;joint pain;
prediabetes
joint pain

Anaesthesiology - Pain management

Metabolic and Endocrine - Diabetes

Musculoskeletal - Other muscular and skeletal disorders

Intervention(s)

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.

Primary Outcome(s)

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. [Baseline (day 0), and 100 days after the trial starting date]

Change in Joint pain measured by Western Ontario and McMaster Universities Arthritis (WOMAC) Index pain subscale-B (WOMAC-B)[Baseline (day 0) and 100 days after the trial starting date]

Secondary Outcome(s)

change in satiety on VAS (0=extremely hungry, 10=extremely full)[Baseline (Day 0) and 100 days after the trial starting date]

change in analgesic medication use ( participant self-report diary) [Day 0 and 100 days after the trial starting date]

This outcome has been removed due to practicality. Patients can't stay for 2 hours.[Baseline (Day 0) and 100 days after the trial starting date]

Change in pain on Visual Analogue Scale (VAS, 0=no pain, 10=worst imaginable pain)[Baseline (Day 0) and 100 days after the trial starting date]

change in anthropometry measured by stadiometer, digital scale, pelvimeter and calipers[Baseline (Day 0) and 100 days after the trial starting date]

Change in composite glucoregulatory markers (glucose, insulin, HbA1c), measured from blood serum samples.[Baseline (Day 0) and 100 days after the trial starting date]

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.[Baseline (Day 0) and 100 days after the trial starting date]

Secondary ID(s)

None

Source(s) of Monetary Support

Beyond Capital MedTech Management Ltd

National Science Challenge High Value Nutrition (Ministry of Business Innovation and Employment)

Secondary Sponsor(s)

Beyond Capital MedTech Management Ltd

Ethics review

Status: Approved
Approval date: 19/11/2020
Contact:

Southern Health and Disability Ethics Committee

Results

• Results available: Yes
• Date Posted: 15/08/2023
• Date Completed: 17/02/2023