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

Audrey Tay; Yannan Jiang; Nada Signal; Daniel O'Brien; Jinsong Chen; Rinki Murphy; Jun Lu

doi:10.3389/fnut.2022.1000510

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

Front Nutr. 2022 Sep 21:9:1000510. doi: 10.3389/fnut.2022.1000510. eCollection 2022.

Authors

Audrey Tay^{1

2}, Yannan Jiang³, Nada Signal⁴, Daniel O'Brien⁴, Jinsong Chen⁵, Rinki Murphy^{1

2

6

7}, Jun Lu^{7

8

9

10

11

12}

Affiliations

¹ Faculty of Medical and Health Sciences, School of Medicine, University of Auckland, Auckland, New Zealand.
² Auckland Diabetes Centre, Auckland District Health Board, Auckland, New Zealand.
³ Department of Statistics, Faculty of Science, University of Auckland, Auckland, New Zealand.
⁴ Faculty of Health and Environmental Sciences, School of Clinical Sciences, Auckland University of Technology, Auckland, New Zealand.
⁵ Faculty of Medical and Health Sciences, School of Population Health, University of Auckland, Auckland, New Zealand.
⁶ Department of Whitiora Diabetes, Counties Manukau District Health Board, Auckland, New Zealand.
⁷ Maurice Wilkins Centre for Biodiscovery, Auckland, New Zealand.
⁸ Faculty of Health and Environmental Sciences, School of Sciences, Auckland University of Technology, Auckland, New Zealand.
⁹ Institute of Biomedical Technology, Auckland University of Technology, Auckland, New Zealand.
¹⁰ College of Food Science and Technology, Nanchang University, Nanchang, China.
¹¹ College of Food Engineering and Nutrition Sciences, Shaanxi Normal University, Xi'an, China.
¹² School of Perfume and Aroma Technology, Shanghai Institute of Technology, Shanghai, China.

Abstract

Introduction: Pharmaceutical 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 analysis: A 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 dissemination: The 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.

Discussion: This 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 registration: https://trialsearch.who.int/Trial2.aspx?TrialID=ACTRN12621000413820, ANZCTR Registration: ACTRN12621000413820, on 15 April 2021.

Keywords: Chinese; fucoidan; green-lipped mussels; joint pain; prediabetes; randomized control trial (RCT).