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Close to the Bone Study

INFORMATION SHEET - Close to the Bone Information Sheet1.pdf (198 KB)

Researcher(s) Introduction

The research group is a team of nutritionists interested in bone health. The lead researcher for this project is Katie Schraders, a PhD student from the School of Food & Advanced Technology (SFAT). Other researchers include Professor Marlena Kruger, Professor Jane Coad, Dr Louise Brough and Dr Jasmine Thomson, also from SFAT.

Project Description and Invitation

Osteoporosis is one of the leading healthcare issues worldwide. Osteoporosis is characterised by changes in bone structure resulting in increased fragility and risk of fractures in older adults. It is estimated that about 22% of women over 50 years of age will develop osteoporosis.

This study aims to investigate the links between bone health and lifestyle factors, specifically the gluten free diet consumed by people with coeliac disease and non-coeliac gluten sensitivity.

If you would be interested in participating, please contact Katie on (06) 356 9099 ext. 85541 or email CloseToTheBone@massey.ac.nz

Participant Identification and Recruitment

We are recruiting women from the lower North Island. We are advertising the study in local media and social media, tertiary education institutes and workplaces and with the assistance of GP clinics and health practitioners. We aim to recruit a total of 141 women; 47 women with coeliac disease (CD), 47 women with non-coeliac gluten sensitivity (NCGS) and a control group of 47 healthy women. These numbers are required for the results to be statistically significant.

Inclusion criteria

To become a participant, you will need to:

- Be a healthy female
OR
- Be a female medically diagnosed with coeliac disease, who has consumed a strict gluten free diet for a  year or more
OR
- Be a female medically diagnosed with non-coeliac gluten sensitivity, who has consumed a strict gluten free diet for a year or more
AND

- Be aged between 18-40 years
- Live in the Palmerston North and Wellington Regions 

Exclusion criteria

Unfortunately, you cannot participate if you:

- Have previously/currently use medication affecting bone metabolism e.g. corticosteroids (daily for >3 months), bisphosphonates, selective oestrogen receptor modulators
- Have a medical condition affecting bone health e.g. osteogenesis imperfecta, chronic renal (kidney) disease, uncontrolled thyroid disease, inflammatory bowel disease (Crohn’s or ulcerative colitis) etc.
- Are currently pregnant or lactating
- Have a known history of inflammatory conditions (other than CD and NCGS)
- Have a BMI>30
- Have not had your condition medically diagnosed according to standard criteria (for the CD and NCGS groups)

If you are unsure whether you are eligible to participate, please contact the lead researcher for further information: Katie Schraders, CloseToTheBone@massey.ac.nz

What is involved?

Healthy control group – prior to participating

If you are part of our healthy control group, we will ask you to undergo a blood test to confirm that you do not have coeliac disease. This test looks for antibodies that are present if you have untreated coeliac disease. If the test identifies anything that needs further investigation, you will receive your test results and a letter to take with you to your GP. Unfortunately, this will mean that you are not eligible to continue with the study.

Everyone – before you come

Prior to your visit to Massey University, we will send you a diet diary and request that for 3 days you record everything you eat and drink. Instructions will be provided.

Everyone – Visit to the HNRU

Once you have completed this we will invite you to come into the Human Nutrition Research Unit (HNRU) at Massey University, in Palmerston North. This visit needs to be in the morning between 8-10am and before you have had any breakfast as we will be starting the visit by taking a few blood samples.

Note: if you are travelling from out of town we can schedule the fasted/time dependent blood tests at your local medical laboratory so that you don’t have to travel too far without breakfast.

Participants are welcome to bring whanau or a support person along to this visit.

We will also ask you to provide a sample of urine and to do a finger prick collection of a few drops of blood to test for anaemia.

After you have provided the blood and urine samples, we will provide you with breakfast. During this time, we may ask you about your diet diary.

Once you have finished breakfast we will ask you to answer some questions about your health, lifestyle, diet and physical activity as well as some questions about how much you know about osteoporosis. This is not a test so please do not study for it, we are simply interested in information you’ve picked up and where you have got this from. You will not be marked on the number of correct answers!

After you have completed the paperwork, we have a new machine that measures your bone quality by ultrasound. The Quantitative Ultrasound transmits and receives sound waves; the intensity and speed of these sound waves are altered by the properties of your bones. Quantitative ultrasound measurements are pretty close to results from medically established methods for diagnosing low bone mineral density. The best part about the Quantitative Ultrasound is that it produces your results pretty much immediately, so you can keep your results after the measurement.

For the last part of your visit we will use a DXA (Dual-emission X-ray Absorptiometry) to measure your bone density, this machine uses very low dose radiation X-rays to measure the bone density of your hip and spine, and also measures your body composition (fat mass, lean mass, and bone mass of your body).

Tests involved – in more detail:

Venous blood sample:

Trained staff will take blood samples from your preferred arm by venepuncture, which is a routine procedure whereby a needle inserted into a vein in the inside of your elbow to collect a blood sample. We know that obtaining blood samples can sometimes cause mild discomfort. We will therefore ask you to sit in a comfortable chair or lie down and the samples will be taken by trained and experienced staff who will do their utmost to reduce this discomfort.  The blood sample will be no more than 44mL (equivalent to about 2 ½ tablespoons in volume). .

Once collected blood samples will be sent to Canterbury Health and Auckland DHB laboratories to measure markers of inflammatory status, bone metabolism, thyroid function, calcium homeostasis and coeliac disease.

Finger prick blood sample:

Trained staff will take a capillary blood sample from your finger using lancet and HEMOCUE Hb 201+ to measure whole blood Haemoglobin value. We will ask you to stay seated in a comfortable chair and the amount of blood taken for this test will only be 2-3 drops. Results from this test only take a few seconds so we will be able to tell you your haemoglobin results straight away.

Urine sample:

For this we ask that you use the private bathroom at the research unit and provide a small mid-stream urine sample in the provided collection cup. Urine samples will be collected to estimate iodine intake (by measuring both iodine and creatinine excreted).

Quantitative Ultrasound bone scan:

Our Achilles Quantitative Ultrasound machine will provide a quick safe and comfortable scan of your non-dominant heel bone using sound-waves. You will feel a warm water filled cushion hugging your heel during your scan. The procedure is quick; just a few minutes from shoe off to shoe on. We will provide you with a printout of your results, for you to keep.

DXA Dual-emission X-ray absorptiometry bone scan:

Measurement involves you lying down on a bed fully clothed in your own clothing without any metal components (e.g. zips, studs, underwire) or surgical scrubs (that we can provide) and scan your bones on the Hologic DXA machine. This machine is used to estimate bone mineral density and bone mineral content of your hip and lumbar spine (L1-L4) and total body composition.

The DXA has X-ray beams of different energies and, while no dose of radiation is harmless, this dose is very low and unlikely to cause harm. The total effective dose of radiation to which you will be exposed to is 21.1 microsieverts (μSv), which is much lower than the range normally used in medical diagnostics. To place this in perspective, the amount of radiation you are exposed to during a return flight to the United Kingdom is 100 μSv and from a dental X-ray 50 μSv.

This procedure is quick, non-invasive and does not require anaesthetic. The room is private, and the staff are experienced and certified. It should take approximately 15 minutes. Your scan results will be assessed and approved by our consultant Radiologist. If your scan shows a T score of > 2.5 standard deviations (S.D) below normal, you will be advised and a copy of the scan, the report from the radiologist and a letter provided to take to your GP to discuss if further investigation is necessary.

Time commitment:

It is expected the diet diaries will take about half an hour to complete in total. The visit and measurements in the Human Nutrition Research Unit should take about one and a half hours.

What benefits you will get from participation:

- You will have contributed to scientific understanding of the influence of Coeliac Disease and Non-Coeliac Gluten Sensitivity on bone health in pre-menopausal women in New Zealand.

- You will not be charged for any of the measurements conducted for the study

- You will be provided with your bone scan results (both from the heel scan and DXA), blood test results and a nutrient analysis of your diet from your 3-day diet diary

- You will get a summary of the study results

Funding has been sought from the ANZBMS and other external funding bodies.

Participation in this study will not result in any costs to you. All tests and sampling for this study will be paid for by the research funding. Participants will also receive reimbursement for their time and travel in the form of a $20 petrol or supermarket voucher.

Data Management

We will keep your name and contact details private and they will be stored in a locked filing cabinet in a locked office and then archived with our other research data before being disposed of in 10 years’ time. You will only ever be identified by a code number for any data analysis and research reports.

Participants results will be kept for 10 years, as bone changes are slow and the research team may wish to invite you back for a follow-up study in future.

Please also bear in mind that it is not advisable for you to have DXA scans performed more frequently than once per year. So, if you have already participated in a bone health study recently and had a DXA scan we would like your permission to obtain a copy of your DXA results from the previous measurement in order to avoid you having a second scan.

Participant’s Rights

You are under no obligation to accept this invitation. If you decide to participate, you have the right to:

- Decline to answer any particular question;

- 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.

Project contacts

There are several researchers involved in this project; however, if you have any questions, concerns or complaints about the project or any of the tests and activities planned, please contact the lead researcher in this instance.

Katie Schraders, PhD candidate/ Lead Researcher
Phone:  06 356 9099 ext. 85541
Email:   CloseToTheBone@massey.ac.nz
School of Food & Advanced Technology
Massey University
Palmerston North

This project has been reviewed and approved by the Massey University Human Ethics Committee: Southern A, Application SOA 18/73.  If you have any concerns about the conduct of this research, please contact Dr Lesley Batten, Chair, Massey University Human Ethics Committee: Southern A, telephone +64 63569099 x 85094, email humanethicsoutha@massey.ac.nz

Compensation for Injury

If physical injury results from your participation in this study, you should visit a treatment provider to make a claim to ACC as soon as possible. ACC cover and entitlements are not automatic and your claim will be assessed by ACC in accordance with the Accident Compensation Act2001. If your claim is accepted, ACC must inform you of your entitlements, and must help you access those entitlements. Entitlements may include, but not be limited to, treatment costs for rehabilitation, loss of earnings, and/or lump sum for permanent impairment. Compensation for mental trauma may also be included, but only if this is incurred as a result of physical injury.

If your ACC claim is not accepted you should immediately contact the researcher. The researcher will initiate processes to ensure you receive compensation equivalent to that to which you would have been entitled had ACC accepted your claim.

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