Combining mussel with fucoidan as a supplement for joint pain and prediabetes: Study protocol for a randomized, double-blinded, placebo-controlled trial

Abstract

IntroductionPharmaceutical drugs are beneficial to inflammatory conditions but with side effects, which led to the search for alternative therapies. Perna canaliculus, the New Zealand green-lipped mussel, have shown promise in placebo-controlled trials for inflammatory conditions. Fucoidan, an extract from seaweed Undaria pinnatifida, has been found to have beneficial effects on joint pain and insulin resistance. However, green-lipped mussel and fucoidan have never been combined.Methods and analysisA parallel, two-arm, double-blind, randomized, placebo-controlled trial will be conducted in New Zealand to determine whether a food product supplemented with green-lipped mussel and fucoidan improves joint pain and/or insulin resistance. Those who are ethnically Chinese, are aged over 30 years, have prediabetes and hip or knee joint pain will be eligible to participate. They will be randomized at 1:1 ratio to consume either dark chocolate supplemented with 1000 mg mussel powder and 1000 mg fucoidan or dark chocolate with no active substances daily for 100 days. The primary endpoints are change in insulin resistance and patient-reported joint pain. Secondary endpoints include anthropometry, fasting glucose and insulin, HbA1c, inflammatory markers, satiety, quality of life, physical function, pain intensity, and analgesic medication use. A sample size of 150 (75 per arm) will provide 90% power at an overall significance level of 5% (two-sided) to detect a standardized effect size of 0.625 on either of the two co-primary outcomes allowing for 10% loss.Ethics and disseminationThe study was approved by the Health and Disability Ethics Committee (number: 20/STH/153). Results will be made available to participants, funders, and other researchers.DiscussionThis trial will provide data on the potential utility of a mussel-fucoidan supplement in reducing joint pain and/or insulin resistance, to inform the development of a supplemented food product suitable for the Chinese market.Clinical trial registrationhttps://trialsearch.who.int/Trial2.aspx?TrialID=ACTRN12621000413820, ANZCTR Registration: ACTRN12621000413820, on 15 April 2021.

Fucoidan suppresses proliferation and epithelial‐mesenchymal transition process via Wnt/β‐catenin signalling in hemangioma

“…33 Based on current toxicological research, the administration of a high dose of fucoidan at 2000 mg/kg/day through oral gavage in rats has not exhibited any indications of adverse reactions. 10 Furthermore, clinical trials have revealed potential advantages of low-dose fucoidan, making it a viable choice for treating conditions like asthma, 34 diabetes 35 and serving as adjunctive therapy for cancer. 36 Considering its protective effect on the cardiovascular system and its low toxicity, 37 we speculate that fucoidan can also be used in the clinical treatment of hemangiomas.…”

Marine Compounds and Age-Related Diseases: The Path from Pre-Clinical Research to Approved Drugs for the Treatment of Cardiovascular Diseases and Diabetes

“…Oral administration of fucoidan to obese non-diabetic patients did not affect glycemia, insulin levels, or insulin resistance compared to controls (ACTRN12614000495628) [167], and no effect of a fucoidan-rich extract from the algae Ascophyllum nodosum was observed on postprandial glucose levels or insulin response in normoglycemic subjects (NCT05460884) [168]. Another clinical study with fucoidan treatment is ongoing on prediabetic individuals (ACTRN12621000413820) [169], which will allow us to define its antidiabetic potential in a more clinically relevant population. A study including healthy participants on the impact of polyphenol-rich brown seaweed (Fucus vesiculosus) extract showed no effect on glycemia or insulin levels (ACTRN12616000126415p) [170], as well as the intake of the Undaria pinnatifida algae (containing fucoidan, fucoxanthin, and polyphenols) in a healthy population, while a hypoglycaemic effect was observed after administration of its sporophylls, likely due to the higher fibre content [171].…”