None listed
Conditions
Brief summary
Type 2 diabetes is linked with many complications such as heart disease, eye disease and kidney disease. People with Type 2 diabetes also have higher rates of diseases of the nervous system in the body including dementia and may have poorer memory and thinking ability compared to people without Type 2 Diabetes. Older people with Type 2 Diabetes are at higher risk for poorer brain function. Diet plays an important role in mental well-being and brain function as the brain needs nutrients found in foods to function well. Omega 3 fatty acids such as those found in fish oils, are found in the brain tissue in large amounts. Increasing dietary intake of fish oils can increase the amount of fish oils in the brain. The aim of this study is to determine if an increase in dietary fish oils can improve the function of the brain in older people with Type 2 diabetes. This pilot study will fill a gap as it is not known if an increase in dietary Omega 3 fatty acids can improve brain function in older people with type 2 diabetes. This is important as the number of older people with diabetes is increasing and currently there are no effective treatments for poor brain function. Eligible volunteers who participate in the study will be given a 6 month supply of fish oil or placebo capsules to take daily. Mental function will be measure by a verbal and computerized tests at the beginning, middle and end of the trial. A blood test, height, weight, and waist circumference will also be collected as well as information about the food you eat and drink at the beginning middle and end of the study. Neither you or the clinician conducting the research will know if you receive the fish oil or the placebo treatment, but a confidential record of which treatment you received will be kept by the chief investigator in the unlikely event you have an adverse reaction.
Interventions
This project involves a medium-term (6-month) randomized, parallel dietary intervention clinical trial. Subjects will be recruited from the 4th year podiatry clinics at the La Trobe Health Sciences Clinic and randomized in one of 2 arms of the trial: (1) placebo supplementation or (2) omega-3 DHA supplementation. Screening, recruitment and intervention are anticipated to occur over a 1 year period. By the end of the second year, data collation and analysis will be finalized.
Screening
The s
This project involves a medium-term (6-month) randomized, parallel dietary intervention clinical trial. Subjects will be recruited from the 4th year podiatry clinics at the La Trobe Health Sciences Clinic and randomized in one of 2 arms of the trial: (1) placebo supplementation or (2) omega-3 DHA supplementation. Screening, recruitment and intervention are anticipated to occur over a 1 year period. By the end of the second year, data collation and analysis will be finalized. Screening The subject pool will comprise patients with Type 2 Diabetes attending podiatry clinics at La Trobe Health Science Clinic. A list of all patients attending clinic on a given day, 50 years or over in age with Type 2 diabetes will be generated from the booking system. Patients will be invited to participate by the researcher in a separate clinic room where the study will be described. If patients are willing to participate they will be invited to complete a standard survey (SF12) assessing their quality of life. In addition, a background questionnaire will provide socio-demographic data, including age, gender, education and past medical history, current medications and physical activity. We will collect information on nutritional supplements, including prescribed ones. Participants will be asked to complete a Food Frequency Questionnaire and a 3-day food diary to eliminate patients already taking fish oil supplements and to monitor dietary confounders. The screening process is anticipated to take 20 mins and can be completed during appointment waiting time. Additional recruitment material and advertising will be placed on the walls of the waiting room with contact details of researchers. Interested participants who contact the researcher can be screened on the phone and food frequency questionnaires and diaries can be mailed out. A prepaid envelope will be provided to return the surveys/ questionnaire. This study is a double blinded randomised controlled trial. Participants will be assigned to received either a daily dose of fish oil capsules containing 1290 mg DHA or placebo (corn oil) administered as three capsules taken before bedtime. Their cognitive function will be measured using standardized computer and verbal test before at the mid point and the end of the trial. The tests used are the Standardise Mini Mental State examination ( SMMSE), California Verbal Learning Test – second edition (CVLT-II) and the Computerised Test of Information Processing (CTIP). Weight, heigh and waist circumference will be taken using standard methods. A blood sample will be taken at baseline, midpoint and end of the trial to measure inflammation and compliance with treatment. Capsules will be provided at the start of the trial and at the midpoint with all unconsumed capsules needing to be returned. Each visit is anticipated to take approximately 60 mins. There are 3 visits in total. The screening and intervention will be conducted by a clinical Dietitian who is trained in anthropometric techniques and dietary analysis and who has additional training in conducing the cognitive tests. The blood samples will be taken by a research team member who has training in blood collection and first aid.
Sponsors
La Trobe Univeristy
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Diagnosed Type 2 diabetes ( diet controlled, taking oral hypoglycaemic agents or insulin) Greater or equal to 50 years of ages Not taking omega 3 supplements Low habitual consumption of oily fish ( < 100g 3 times per week) Fluent in English
Exclusion criteria
Less than 50 years of age Clinically established history of psychiatric disorder including depression and substance/ alcohol abuse Clinically established history of co-morbid neurological disorder liable to affect cognition, including dementia Taking omega 3 supplements High habitual consumption of oily fish ( > 100g 3 times per week)
Outcome results
None listed