Data_Sheet_1_Combining mussel with fucoidan as a supplement for joint pain and prediabetes: Study protocol for a randomized, double-blinded, placebo-controlled trial.doc

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.</p

Additional file 1: of Five year trends in the serve size, energy, and sodium contents of New Zealand fast foods: 2012 to 2016

Appendix 1. Preparation of fast food data for analysis. Appendix 2. Total products and unadjusted mean (SD) values included in main analyses by year, food group, fast food chain, and outcome*. Appendix 3. Summary of products included in reformulation analyses sold in two or more years by year, food group, fast food chain, and outcome. Appendix 4. Model adjusted means, 95% CI’s and p-values for all products in main analyses by year, food group, and outcome*. Appendix 5. Model adjusted means, 95% CI’s and p-values for reformulation analyses including products available for sale in two or more years by year, fast food chain, and outcome*. (XLSX 134 kb

Characteristics and effectiveness of 40 school-based obesity treatment studies targeting overweight and obese children.

<p>Characteristics and effectiveness of 40 school-based obesity treatment studies targeting overweight and obese children.</p

The summarized characteristics of the included studies.

<p>The summarized characteristics of the included studies.</p

Summary of the quality assessment components for 76 included studies.

<p>Summary of the quality assessment components for 76 included studies.</p

Characteristics and effectiveness of 36 school-based obesity prevention studies for all children.

<p>Characteristics and effectiveness of 36 school-based obesity prevention studies for all children.</p

Flow chart of systematic review.

<p>Flow chart of systematic review.</p

Meta-analyses on the change in body mass index for school-based obesity prevention studies.

<p>(a) Change in body mass index for studies using physical activity only. (b) Change in body mass index for studies using both physical activity and health education with or without other components. *, weak 2 quality; **, weak 1 quality; ***, moderate quality. b, boys only; g, girls only.</p

Characteristics of patients who had an on-line CVD risk assessment form opened in the 8 months before and after 12 months commencement of the trial.

<p>Characteristics of patients who had an on-line CVD risk assessment form opened in the 8 months before and after 12 months commencement of the trial.</p

The impact of a point-of-care testing device on CVD risk assessment completion in New Zealand primary-care practice: A cluster randomised controlled trial and qualitative investigation

<div><p>Objectives</p><p>To assess the effect of a point of care (POC) device for testing lipids and HbA_1c in addition to testing by community laboratory facilities (usual practice) on the completion of cardiovascular disease (CVD) risk assessments in general practice.</p><p>Methods</p><p>We conducted a pragmatic, cluster randomised controlled trial in 20 New Zealand general practices stratified by size and rurality and randomised to POC device plus usual practice or usual practice alone (controls). Patients aged 35–79 years were eligible if they met national guideline criteria for CVD risk assessment. Data on CVD risk assessments were aggregated using a web-based decision support programme common to each practice. Data entered into the on-line CVD risk assessment form could be saved pending blood test results. The primary outcome was the proportion of completed CVD risk assessments. Qualitative data on practice processes for CVD risk assessment and feasibility of POC testing were collected at the end of the study by interviews and questionnaire. The POC testing was supported by a comprehensive quality assurance programme.</p><p>Results</p><p>A CVD risk assessment entry was recorded for 7421 patients in 10 POC practices and 6217 patients in 10 control practices; 99.5% of CVD risk assessments had complete data in both groups (adjusted odds ratio 1.02 [95%CI 0.61–1.69]). There were major external influences that affected the trial: including a national performance target for CVD risk assessment and changes to CVD guidelines. All practices had invested in systems and dedicated staff time to identify and follow up patients to completion. However, the POC device was viewed by most as an additional tool rather than as an opportunity to review practice work flow and leverage the immediate test results for patient education and CVD risk management discussions. Shortly after commencement, the trial was halted due to a change in the HbA_1c test assay performance. The trial restarted after the manufacturing issue was rectified but this affected the end use of the device.</p><p>Conclusions</p><p>Performance incentives and external influences were more powerful modifiers of practice behaviours than the POC device in relation to CVD risk assessment completion. The promise of combining risk assessment, communication and management within one consultation was not realised. With shifts in policy focus, the utility of POC devices for patient engagement in CVD preventive care may be demonstrated if fully integrated into the clinical setting.</p><p>Trial registration</p><p>Australian New Zealand Clinical Trials Registry <a target="_blank">ACTRN12613000607774</a></p></div