Participant Information Sheet

ROAM Study (Researching Osteoarthritis and Greenshell mussels)

Participant information sheet - ROAM (272 KB)
Lead Researcher: Professor Pamela von Hurst

Study Site: Human Nutrition Unit, Massey University
Contact phone number: 09 414 0800 ext 43657
Ethics committee ref.: 20/CEN/218

You are invited to take part in a study on the role of Greenshell mussel and selected lifestyle and nutritional factors in knee osteoarthritis (The ROAM Study).  Whether or not you take part is your choice. If you don’t want to take part, you don’t have to give a reason, and it won’t affect the care you receive. If you do want to take part now, but change your mind later, you can pull out of the study at any time. 

This Participant Information Sheet will help you decide if you’d like to take part. It sets out why we are doing the study, what your participation would involve, what the benefits and risks to you might be, and what would happen after the study ends. We will go through this information with you and answer any questions you may have. You do not have to decide today whether or not you will participate in this study. Before you decide you may want to talk about the study with other people, such as family, whānau, friends, or healthcare providers. Feel free to do this.

If you agree to take part in this study, you will be asked to sign the Consent Form on the last page of this document.  You will be given a copy of both the Participant Information Sheet and the Consent Form to keep.

Voluntary Participation and Withdrawal From This Study

Participation in this study is completely voluntary. You are under no obligation to accept this invitation. If you decide to participate, you have the right to:

·       Decline to answer any particular questions
·       Withdraw from the study at any time
·       Ask any questions about the study at any time during participation
·       Provide information on the understanding that your name will not be used unless you give permission to the researcher
·       Be given access to a summary of the project findings when it is concluded

Withdrawing from the study, should you choose to, will not result in any disadvantage to you.

What is the purpose of the study?

Osteoarthritis (OA) is the most common form of joint disease and the leading cause of disability in older adults worldwide. It is a progressive disease leading to deterioration of all parts of the joint structure resulting in pain and loss of function. In New Zealand, OA affects 10.2% of the adult population with incidence increasing with age.

Osteoarthritis is a multifactorial disease with genetic and environmental components. Lifestyle and Dietary factors may influence the course of OA, though there is insufficient evidence about the role of these factors in the development of OA in New Zealand.

There is no cure for OA and conventional treatment is mainly focused on symptom management or joint replacement. Dietary intake of foods with anti-inflammatory or cartilage protective properties may have an effect on osteoarthritis signs and symptoms. Oil extract from the GSM, a native New Zealand shellfish, has been shown to be effective in reducing OA symptoms. A recent animal study showed flash­dried powder from whole GSM meat also has preventive effects for those in early stages of the disease by reducing a marker in the blood that measures cartilage breakdown.

The aims of this project are to investigate the role of lifestyle and nutritional factors in early signs and symptoms of OA in adults, and to see if whole meat GSM powder has a joint protective effect in adults with early signs and symptoms of the disease.

How is the study designed?

The ROAM study will involve 320 men and women age 60-74 years. 160 participants taking part in the Greenshell mussel intervention arm of the study (those with early signs and symptoms of osteoarthritis) and another 160 participants taking part in the case control arm of the study (those without early signs and symptoms of osteoarthritis).  Participants will take part in online or telephone screening to check eligibility. If eligible they will visit the Human Nutrition Unit at Massey University, once for approximately 2 hours, if they are taking part in the case control arm of the study and twice, for approximately 5.5hrs in total, if they are in the intervention arm of the study.

The intervention capsules with either be Greenshell mussel powder (taken as 2 capsules, 3 times per day with each meal) or a placebo capsule of sunflower seed protein (also taken as 2 capsules, 3 times per day). Participants will be randomly allocated into those taking Greenshell mussel or placebo by somebody outside of the study and neither the participant nor the researchers on the study will know which capsules they are taking. Those in the case control arm of the study will not take any intervention or placebo capsules.

Participants on both arms of the study will be required to have body composition measurements and fill out questionnaires regarding health, demographics, lifestyle, physical activity and dietary intake. In addition, those on the intervention arm of the study will be asked to provide fasted blood and urine samples, answer questionnaires on joint health and complete simple performance measures to assess joint functionality.

Who can take part in the study?

Healthy men and women aged between 60-74 years, with no history of trauma to knee or hip joints, no formal diagnosis of osteoarthritis or rheumatoid arthritis by a clinician, not be allergic to seafood, and not regularly (more than once per week) using medications which may affect joint health and/or pain will be screened for early signs and symptoms of OA through their answers to the Knee Injury and Osteoarthritis Score (KOOS) questionnaire. Participants should also be able to speak and read English due to the nature of questionnaires. Based on the KOOS results, participants will be categorised into two groups:

·       Participants who have early signs/symptoms of OA (n=160): These participants will be included in the intervention arm of the study and also be considered cases for the case control arm of the study.

·       Participants who do not have early signs/symptoms of OA (n=160): These participants will not be included in the intervention arm of the study but will be considered as controls for the case-control arm of the study.

Participants in the intervention arm of the study will also be ineligible if they are:

·       Unable to stop supplements which may affect results for a 4 week washout period before and during the study, e.g. supplements for joint health, GSM, glucosamine, chondroitin, fish oils, PUFAs, methylsulfonylmethane (MSM), avocado soybean unsaponifiables (ASU),  ginger (anti-inflammatory), turmeric (anti-inflammatory).

·       Unable to stop medications used occasionally (once per week or less) which may affect results for a 4-week washout period before and during the study, e.g. anti-inflammatories (NSAIDs, corticosteroids), diacerein, steroid injections, hyaluronic acid injections.

Participants in the intervention arm of the trial will be advised to eat oily fish and seafood no more than two servings per week (as per the NZ healthy eating guidelines). Fish and seafood intake will be monitored using the food frequency questionnaire.

What will my participation in the study involve?

If you decide to take part in this project, after you have read and had time to consider the information in this information sheet, you will be required to complete the screening process. Screening involves answering a few inclusion criteria questions, and this can be done at home and takes approximately 15mins. If you meet the initial inclusion criteria and are eligible, you will be asked to complete a questionnaire on joint health, the Knee Injury and Osteoarthritis Outcome Survey (KOOS), which takes approximately 15mins. Your answers to this questionnaire will help us to see if you have early signs and symptoms of OA or not.

What will happen if my answers to the joint health questionnaire show that I have early signs and symptoms of OA?

If you have early signs and symptoms of OA you will receive the intervention (this means you will be taking study capsules for 6 months). You will be randomly assigned to take either GSM or placebo capsules. You and the researchers will not know which capsules you will be taking until the end of the study. Both randomisation and blinding are necessary to reduce bias of both participants and researchers and keep the study valid. A researcher will make an appointment with you to visit the Human Nutrition Unit at Massey University in Albany on two occasions, initial (first) visit and final visit (after six months), at a time early in the morning, before you have eaten breakfast. You should not eat or drink anything (other than water) from 10pm the previous evening. A light breakfast will be available. The total time involved will be approximately 6 hours over a 6 month period and you will be reimbursed for time and travel ($200 in vouchers).

At the initial (first) appointment, you will first be asked to sign a consent form for participating in the study and you will have the opportunity to ask any questions you may have about the study. During this initial visit we will ask you to:

·       Complete demographic, health (confirmed medical conditions and medications), and lifestyle questionnaires.
·       Complete a questionnaire to assess physical activity.
·       Complete a questionnaire to assess dietary intake.
·       Have percentage body fat measured using Bioelectrical Impendence Analysis (BIA) and Dual X-Ray Absorptiometry (DXA). See appendices 1 and 2.
·       Provide a small blood sample (about 20ml which is equivalent to 4 teaspoons). This will be taken by a qualified phlebotomist. It will be used to measure levels of the cartilage synthesis marker, type II procollagen (CP­II), markers of cartilage degradation, C­telopeptide of type II collagen (CTx­II) and cartilage oligomeric matrix protein (COMP) and markers of inflammation (C­reactive protein, hs­CRP and cytokines). It will also be used to measure other blood biomarkers of nutritional status, e.g. iron, Vitamin D, selenium, iodine and fatty acids.
·       Provide a urine sample (2nd void of the day) to measure levels of C­telopeptide of type II collagen (CTx­II)
·       Complete 3 performance outcome measures. These are, the 30 Second Chair Stand Test, the Stair Climb Test and the 40m Fast Paced Walk Test.
·       Complete questionnaires to assess joint health. These are, The Knee Injury and Osteoarthritis Outcome Survey (KOOS), Measure of Intermittent and Constant Pain (ICOAP) and Visual Analogue Scale (VAS)

During this appointment we will give you the GSM or placebo capsules you will be required to take for the next 6mths and explain how to fill in the adverse effects/compliance diary at home. We will also book you in for your final visit in 6mths time. This initial visit will take approximately 3 hours in total.

After 6mths of taking the GSM or placebo capsules you will be required to return to the Human Nutrition Unit at Massey University in Albany. This final visit will again be early in the morning before you have eaten breakfast. You should not eat or drink anything (other than water) from 10pm the previous evening. During this final visit we will ask you to repeat the same tests as at the first visit with the exception of:

- Demographic, health, and lifestyle questionnaire.
- Have percentage body fat measured using Dual X-Ray Absorptiometry (DXA)

You will also be required to hand in any left-over capsules you may have. This final visit will take approximately 2.5 hours in total.

What will happen if my answers to the joint health questionnaire show that I do not have early signs and symptoms of OA?

If you do not have early signs and symptoms of OA, you will not receive the intervention (this means you will not be taking study capsules for 6 months). You will be required to visit Human Nutrition Unit at Massey University in Albany on one occasion for data collection. A researcher will make an appointment with you at your convenience. This visit will take approximately 2 hours and you will be reimbursed for time and travel ($50 in vouchers).

At this appointment you will first be asked to sign a consent form for participating in the study and you will have the opportunity to ask any questions you may have about the study. During this visit, we will ask you to:

 -Complete demographic, health, and lifestyle questionnaire.
- Complete a questionnaire to assess physical activity
- Complete a questionnaire to assess dietary intake
- Have percentage body fat measured using Bioelectrical Impedance Analysis (BIA)

What will happen to my blood and urine samples?

All samples will be labelled with the participant’s unique identity code/number and not by the participant’s name.

The blood samples will be stored in a ­80 degree freezer for up to 12 months during which time the biochemical analysis will be conducted. While waiting for analysis for cartilage biomarkers, samples will be kept in the freezer at the Nutrition laboratory at Massey University, building 27, Oteha Rohe campus, Albany. Some serum/plasma samples will also be sent to the accredited laboratories, for example the University of Otago, Canterbury Health Laboratories, Cawthron Institute and LabPlus to assess metabolomics, inflammatory markers, vitamin D and iron status.

The urine samples will be stored at -70?C for up to 12mths in the freezer at the Nutrition laboratory at Massey University, building 27, Oteha Rohe campus, Albany for analysis for cartilage biomarker (CTx-II).

Participants may ask to withdraw their samples at any time during the study.

Māori participants will be fully informed and have time to make their decision to be a part of the study. They will be given full information regarding the disposal of samples and the opportunity to observe appropriate tikanga Māori practice while taking part in the study. For example, the research team will offer participants the opportunity to karakia while blood samples are being taken and the option for disposal of whole blood samples if they wish. Bodily samples will be handled with integrity in the knowledge that the material is still considered living and therefore a treasure.

What are the possible risks of this study?

Some people may have a fear of having a blood sample taken or experience discomfort when blood samples are taken. Occasionally a slight bruising will result. The bruising usually disappears within a day or two. Blood samples will be taken by a trained phlebotomist. There may be social or cultural discomfort from having a blood sample, body composition measurements or performance-based measurements taken, however, you will be treated with respected and privacy will be ensured. We will explain all measurements being taken and ask for your permission prior to undertaking these measurements. You may also be accompanied by a support person if required. Every effort will be made to ensure your comfort and respect your participation.

We will use the Hologic DXA machine to estimate body fat percentage. The DXA has X-ray beams at 2 different energies. This dose is very low and unlikely to cause harm. The total effective dose of radiation to which you will be exposed is 10 microsieverts (μSv), this is much lower than the range normally used in medical diagnostics. To put it in perspective, the amount of radiation you are exposed to during a flight to the United Kingdom return is 100 μSv and from a dental X-ray 50 μSv. The room is private and you can enter the DXA machine in complete privacy. We will provide you with a gown to wear during this measurement.

What are the possible benefits of this study?

It is unknown whether there will be any individual benefit of taking part in the study. However, there is a benefit of contributing to a better knowledge of OA risk factors, and to obtaining an in-depth understanding of the effects of Greenshell mussels on early signs and symptoms of osteoarthritis. You will receive a brief report summarising the main findings of the project via mail or email.

Will any costs be reimbursed?

Participant will not incur any costs as part of being involved in the study and will receive reimbursement for time and travel ($200 in vouchers).

What if something goes wrong?

If you were injured in this study, you would be eligible to apply for compensation from ACC just as you would be if you were injured in an accident at work or at home. This does not mean that your claim will automatically be accepted. You will have to lodge a claim with ACC, which may take some time to assess. If your claim is accepted, you will receive funding to assist in your recovery.

If you have private health or life insurance, you may wish to check with your insurer that taking part in this study won’t affect your cover.

What will happen to my information?

During this study the researchers will record information about you and your study participation. This includes the results of any study assessments. You cannot take part in this study if you do not consent to the collection of this information.

Identifiable Information

Identifiable information is any data that could identify you (e.g. your name, date of birth, or address). The following groups may have access to your identifiable information:

- Research staff (to complete study assessments)

- Government agencies, like HDEC, ACC and its representatives, if you make a compensation claim for study-related injury. Identifiable information is required in order to assess your claim.

- Your usual doctor, if a study test gives an unexpected result that could be important for your health. This allows appropriate follow-up to be arranged.

De-identified (Coded) Information

To make sure your personal information is kept confidential, information that identifies you will not be included in any report generated by the researcher. Instead, you will be identified by a code. The researcher will keep a list linking your code with your name, so that you can be identified by your coded data if needed.

The results of the study may be published or presented, but not in a form that would reasonably be expected to identify you.

Security and Storage of Your Information

Your identifiable information is held at Massey University during the study. After the study it is transferred to a secure archiving site and stored for at least 10 years, then destroyed. Your coded information will be entered into electronic case report forms. Coded study information will be kept in secure, cloud-based storage indefinitely. All storage will comply with local and/or international data security guidelines.

The linked data in this study will be destroyed at the end of the study.

Risks

Although efforts will be made to protect your privacy, absolute confidentiality of your information cannot be guaranteed. Even with coded and anonymised information, there is no guarantee that you cannot be identified.  The risk of people accessing and misusing your information (e.g. making it harder for you to get or keep a job or health insurance) is currently very small but may increase in the future as people find new ways of tracing information.

Rights to Access Your Information

You have the right to request access to your information held by the research team. You also have the right to request that any information you disagree with is corrected. 

Please ask if you would like to access the results of your screening and safety tests during the study. You may access other study-specific information before the study is over, but this could result in you being withdrawn from the study to protect the study’s scientific integrity.  

If you have any questions about the collection and use of information about you, you should ask researcher.

Rights to Withdraw Your Information

You may withdraw your consent for the collection and use of your information at any time, by informing the study researchers. 

If you withdraw your consent, your study participation will end, and the study team will stop collecting information from you.

Information collected up until your withdrawal from the study will continue to be used and included in the study. This is to protect the quality of the study.

What happens after the study or if I change my mind?

If you wish to withdraw from the study, please inform one of the research team. Information and data collected up until your withdrawal from the study will continue to be used and included in the study. This is to protect the quality of the study.

The data will be used for the purposes of this study, and fully anonymised, selected outcomes may be shared with other researchers on request for the purpose of accumulating data from individual studies. Only investigators and administrators of the study will have access to personal information, and this will be kept secure and strictly confidential. Participants will be identified only by a study identification number. Results of this project may be published or presented at conferences or seminars. No individuals will be able to be identified.

At the end of this study the list of participants and their study identification number will be disposed of. Any raw data on which the results of the project depend will be retained in secure storage for 10 years, after which it will be destroyed.

All participants will have access to a summary of the project findings and which treatment group they were in when the study is completed.

Can I find out the results of the study?

All participants will have access to a summary of the project findings when it is completed.

The study is registered with the Australian New Zealand Clinical Trials Registry and can be accessed at www.ANZCTR.org.au.

Who is funding the study?

This study is funded by the National Science Challenge, High Value Nutrition (HVN) as part of the “Musseling up: High-value Greenshell Mussel Foods” Tranche II, a collaboration between Massey University, Cawthron Institute and Sanford Ltd. HVN operates from University of Auckland and is underwritten by the Ministry of Business, Innovation and Employment.

Participants will not incur any costs for taking part in the study and will be reimbursed for time and travel.

Who Has Approved the study?

This study has been approved by an independent group of people called a Health and Disability Ethics Committee (HDEC), who check that studies meet established ethical standards. The Central Health and Disability Ethics Committee has approved this study.

Who do I contact for more information or if I have concerns?

If you have any questions, concerns or complaints about the study at any stage, you can contact:

Cassie Slade, PhD candidate
Phone: (09) 213 6859
Email: c.slade2@massey.ac.nz

Dr Hajar Mazahery, Post Doctoral Fellow
Phone: (09) 414 0800 ext 43650
Email: h.mazahery@massey.ac.nz

Owen Mugridge, Research Trials Manager
Phone: (09) 213 6650
Email: o.mugridge@massey.ac.nz 

The other members of the research team are: Professor Pamela von Hurst, Professor Marlena Kruger, Associate Professor Cathryn Conlon and Associate Professor Kathryn Beck (College of Health, Massey University) and Dr Matt Miller (Cawthron Institute).

If you want to talk to someone who isn’t involved with the study, you can contact an independent health and disability advocate on:

Phone:            0800 555 050
Fax:                 0800 2 SUPPORT (0800 2787 7678)
Email:              advocacy@advocacy.org.nz

Website:          https://www.advocacy.org.nz/

For Maori health support please contact: 

Te Rerekohu Tuterangiwhiu, Cawthron Maori Development Team
Email: tererekohu.tuterangiwhiu@cawthron.org.nz

You can also contact the health and disability ethics committee (HDEC) that approved this study on:

            Phone:             0800 4 ETHIC
            Email:              hdecs@health.govt.nz

Contact us Mon - Fri 8:30am to 4:30pm 0800 MASSEY (+64 6 350 5701) TXT 5222 contact@massey.ac.nz Web chat Staff Alumni News Māori @ Massey

必威