The REACH Study – Researching Eating Activity and Cognitive Health

INFORMATION SHEET -  REACH Study - information sheet1.pdf (281 KB)

Researchers Introduction


We would like to invite you to take part in the REACH (Researching Eating Activity and Cognitive Health) Study. The purpose of the study is to identify dietary patterns in older adults and explore their association with cognitive function.  We will also look at other health outcomes associated with aging, including novel metabolic biomarkers, genetics, and factors influencing mobility. This study is being conducted by a group of researchers from Massey University and the University of Otago, New Zealand and overseas (who are listed at the end of the information sheet).  
    
Please read this Information Sheet carefully before deciding whether or not to participate.

Project Description and Invitation

The New Zealand population is ageing, with 21% of the population expected to be over 65 years by 2031. Optimising cognitive function for as long as possible is critical for successful ageing. Diet and lifestyle are important factors to prevent cognitive decline.  However, to date most research has focused on single nutrients (eg. omega 3) and foods (eg. fish). This has several limitations as people do not consume foods and nutrients in isolation but as combinations of foods and nutrients resulting in dietary patterns. ‘Dietary patterns’ (a relatively new approach to assessing dietary intake) capture the overall complexity of the diet.  Overseas research has linked dietary patterns to health outcomes including cognitive function. However, very little research has considered dietary patterns in the context of genetics, and other lifestyle factors (eg. physical activity). This study aims to identify dietary patterns in older adults living in New Zealand and explore their association with cognitive function and other health outcomes associated with aging.

Participant Identification and Recruitment

Who are we looking for?
    
We are looking for 360 male and female volunteers to participate in this study.  To take part in this study you should:
-    Be between 65-74 years of age
-    Be living independently (not requiring assistance with daily activities or 24/7 skilled nursing)
-    Be proficient in English
-    Not have had a diagnosis of dementia.  
-    Not have or have had any of the following conditions which may cause impairments in cognitive function: stroke, traumatic head/brain injury, have a neurological or psychiatric condition.
-    Not be colour blind.
-    Not be taking medication which may influence cognitive function.  

Due to the type of study this is we can only include one person from any household. However, you are welcome to bring a family member or support person with you.

Project Procedures

What is going to happen?

The total time involved in this study is approximately 4.5 hours. If you decide to take part in this study after you have read and had time to consider the information contained in this information sheet, you will be asked to complete a screening questionnaire to ensure that you meet the criteria to take part in the study. If you meet the inclusion criteria you will be invited to take part in the study. A researcher will then make an appointment with you to visit the Human Nutrition Research Unit at Massey University in Albany at a time early in the morning before you have had breakfast.  You should not eat or drink anything (other than water) from 10pm the previous evening.  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 about the study.

We will reimburse you for your travel costs and give you a free breakfast.  During this initial visit we will ask you to:

  • Complete a health and demographic questionnaire.
  • Have height, weight, waist and hip circumference measured.
  • Have percentage body composition (fat) measured using Dual X-Ray Absorptiometry (DXA).
  • Have your blood pressure and grip strength measured.
  • Have an ultrasound scan of your knee(s) to look for signs of osteoarthritis
  • Provide a small blood sample will be taken by a qualified phlebotomist (about 20ml which is equivalent to 4 teaspoons) for the measurement of glucose, HDL and LDL cholesterol, triglycerides, HbA1C, single nucleotide polymorphisms (SNPs), metabolites and nutrients specific to dietary intake (such as vitamin C, β-carotene and folate), inflammatory markers (such as C-RP, TNF-α, IL-6, IL-1) and cartilage oligomeric matrix protein and C-telopeptide, a both markers of arthritis in your blood. We will also measure the ApoE ԑ4 genotype.  As ApoE ԑ4 is a gene which may affect cognitive function it is important to consider ApoE ԑ4 when investigating the relationship between dietary patterns and cognitive function.  
  • Complete a series of cognitive tasks on paper (Montreal Cognitive Assessment test) and on the computer (the Computerised Mental Performance Assessment System (COMPASS)). COMPASS includes a range of tests which measure different areas of brain function such as attention and memory.  We will train you on how to use the computer to complete the tasks.
  • Complete questionnaires to assess your dietary intake and physical activity levels
  • Participants will be asked to complete a short questionnaire – The KOOS or “Knee Injury and Osteoarthritis Outcome Survey” to assess any symptoms of osteoarthritis in your knees.

This visit will take about 3 hours in total.  Following this appointment, we will ask you to record everything you eat and drink on a form while at home for a period of four days.  We will also send you a questionnaire / link with some more questions regarding your dietary intake 4-8 weeks following your first appointment (approximately 1.5 hours required at home).

What are the benefits and risks of taking part in this study?

You will receive feedback on your individual blood (glucose, HDL cholesterol, LDL cholesterol, triglycerides, HbA1C), blood pressure and body composition results. Blood results outside the normal range will be reviewed by a vocationally registered general practitioner (GP) under the NZ Medical Council, who will advise if you need to visit your GP.  The DXA body composition scan also provides minimal information on your bone mineral density. If this scan indicates the need for further investigation of your bone health, we will inform you of this and recommend you consult your GP. We encourage you to share these results with their your General Practitioner, whether or not any abnormalities are detected. If you elect to receive the results of your tests, and you seek life or health insurance you or your GP can be asked to disclose them by the insurer.  Failure to disclose them could invalidate any insurance policy issued where disclosure has not been made.

We will be measuring the genetic factors (SNPs) and the metabolome from a blood sample.  SNPs are a DNA sequence variation occurring commonly within a population. The metabolome is a set of compounds found in your blood including amino acids, fatty acids, nucleic acids, hormones, enzymes, amines, vitamins, organic acids, short peptides, and sugars, as well as environmental contaminants, food additives, toxins, and drug metabolites.  As these results are non-diagnostic they will not be made available to participants.  One genetic factor we will be measuring is known as the ApoE ԑ4 allelic variant.  Carriers of the ApoE ԑ4 allelic variant (25% of the population) are at substantially increased risk of Alzheimer’s Disease.  However, inheriting an ApoE ԑ4 allele does not mean a person will develop Alzheimer’s disease. Therefore, results of the ApoE genotype test will be anonymised and not given to participants. None of the cognitive tasks are diagnostic so results of these will not be provided to participants.  

The principal benefit of taking part in this study is a contribution to obtaining an in-depth understanding of the dietary patterns of adult New Zealanders (beyond an isolated food and nutrient approach) and advancing our knowledge of their associations with cognitive function and health outcomes associated with ageing.  This is the first important step on a pathway to developing recommendations for adult New Zealanders to maintain cognitive function and health as long as possible.  You will receive a brief report summarising the main findings of the project via mail or email.  After completing the study, you will receive a link to the Ministry of Health Food and Nutrition Guidelines for Healthy Older Adults.  You will be reimbursed for travel costs with a $50 voucher following your visit.

Some people may have a fear of having a blood sample taken or experience discomfort when the 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, grip strength or body composition measurements taken, however, privacy will be ensured, you will be treated with respect. The height measurement involves standing upright, and the researcher bringing a head plate gently onto the top of your head and compressing the hair if necessary.  We will explain all measurements 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 to is 10 microsieverts (µSv), which is much lower than the range normally used in medical diagnostics. To place 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 Xray 50 µSv.  The room is private and you can enter the DXA room in complete privacy. We will provide you with a gown to wear during this measurement.

Data Management

The data will be used only for the purposes of this project and no individual will be identified.  Only the 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 individual 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.  

The ApoE4 genotype results will be stored separately and only Dr Kathryn Beck and Owen Mugridge will have access to these records.

Who is funding the research?

This research is funded by a New Zealand Health Research Council Emerging Researcher Grant.

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.

Committee Approval Statement

This project has been reviewed and approved by the Massey University Human Ethics Committee: Southern A, Application 17/69.  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 06 356 9099 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 Act 2001.  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, travel 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.

Thank you for considering participating in this study!

The REACH Study Research Team

Massey Contact Centre 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