None listed
Conditions
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.
Interventions
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
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.
Sponsors
University of Auckland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
30 Years to 80 Years
Healthy volunteers
No
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.
Outcome results
None listed