None listed
Conditions
Brief summary
This is a placebo-controlled, double-blind, randomized, crossover trial. Conditions will follow a 2 (placebo/glucose) X 2 (+/- secondary task) design. Participants will be required to come for 5 visits. The first visit is a practice day where participants complete screening questionnaires and familiarise themselves with the study procedures and tests. The following 4 days are scheduled at least 48 hours apart and participants are randomised to receive one of two treatment drinks (25g glucose/placebo) and +/- the secondary tracking task. They then undergo 8 blocks of testing. In each block they will be presented with 20 words in the auditory modality, via headphones connected to a computer. If they are in the secondary tracking task condition, they complete the tracking task on the computer while listening to the words. Following the word presentation, there is a word recognition task where participants are presented with the 20 original words mixed with 20 new words. Participants indicate whether or not the word was in the original list by clicking ‘yes’ or ‘no’. If they indicate yes, they are prompted to indicate whether they (1) remembered it was in the original list, (2) know it was in the original list, or (3) guessed it was in the original list. 64 channels of EEG will be recorded during whilst participants perform this recognition memory task. Levels of blood glucose, insulin and cortisol will be taken throughout the study days
Interventions
This is a placebo-controlled, double-blind, randomized, crossover trial. Conditions will follow a 2 (placebo/glucose) X 2 (+/- secondary task) design.
Participants will be required to come for 5 visits. The first visit is a practice day where participants complete screening questionnaires and familiarise themselves with the study procedures and tests. The following 4 days are scheduled at least 48 hours apart and participants are randomised to receive one of two treatment drinks (25g glucose/pl
This is a placebo-controlled, double-blind, randomized, crossover trial. Conditions will follow a 2 (placebo/glucose) X 2 (+/- secondary task) design. Participants will be required to come for 5 visits. The first visit is a practice day where participants complete screening questionnaires and familiarise themselves with the study procedures and tests. The following 4 days are scheduled at least 48 hours apart and participants are randomised to receive one of two treatment drinks (25g glucose/placebo) and +/- the secondary tracking task. Participants will be given a glucose drink on two testing days and a placebo drink on two testing days to be consumed orally. The drinks contain 20 ml of orange cordial in 150 ml water containing either 25g of glucose or 30 mg saccharine. These drinks have been used in numerous previous experiments into the effects of glucose on cognition. The two drinks are sensorily indistinguishable. If they are in the secondary tracking task condition, they complete the tracking task on the computer while listening to the words. Following the word presentation, there is a word recognition task where participants are presented with the 20 original words mixed with 20 new words. Participants indicate whether or not the word was in the original list by clicking ‘yes’ or ‘no’. If they indicate yes, they are prompted to indicate whether they (1) remembered it was in the original list, (2) know it was in the original list, or (3) guessed it was in the original list. Drinks will be consumed within 5 minutes, thereafter followed by secondary tracking task and memory encoding.
Sponsors
Swinburne University of Technology
Study design
Allocation
Randomised controlled trial
Intervention model
Factorial
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Healthy non-smoking males and females aged over 65 2. No history of anxiety, depression, psychiatric disorders (confirmed using DASS) or epilepsy 3. No history of / do not currently suffer from heart disease or high blood pressure or diabetes 4. Not taking any medication, herbal extracts, vitamin supplements or illicit drugs which might reasonably be expected to interfere with blood glucose levels, for 4 weeks prior to (and duration of) study 5. Not taking any form of medication within 5 days of admission (except for prophylactic antibiotics, or other routine medications to treat benign conditions, such as antibiotics to treat acne) and agree not to take any medication throughout the study 6. No health conditions that would affect food metabolism including the following: food allergies, kidney disease, liver disease and/or gastrointestinal diseases (e.g. Irritable bowel syndrome, coeliac disease, peptic ulcers) 7. Are willing and able to participate in all scheduled visits, treatment plan, dietary restrictions, tests and other trial procedures according to the protocol. Also comfortable with computers. 8. Are willing to provide small finger prick blood samples and blood samples throughout the testing phases 9. Absence of cognitive decline and a score > 24 on the Mini Mental State Examination (MMSE) 10. Understand the rating scales and computer tests (as judged by the study coordinator) 13. Provide a personally signed and dated informed consent indicating that the participant has been informed of all pertinent aspects of the trial. 14. Have a fasting blood glucose <6.1mmol/l
Exclusion criteria
1. Smoker 2. Diagnosis of Type 1 or Type 2 diabetes 3. History of hypersensitivity to glucose 4. History of anxiety, depression, psychiatric disorders or epilepsy 5. History of / currently suffers from heart disease or high blood pressure or diabetes 6. Evidence or history of any clinically significant (in the judgment of the investigator) renal, endocrine, pulmonary, gastrointestinal, cardiovascular, psychiatric, neurological, within the last 5 years 7. Use of any over-the-counter herbal extracts, vitamin supplements and/or other dietary supplements which might influence glucose absorption or metabolism for four weeks prior to the practice day 8. Taking any illicit drugs 9. Health conditions that would affect food metabolism including the following: food allergies, kidney disease, liver disease and/or gastrointestinal diseases (e.g. have Irritable bowel syndrome, peptic ulcers) 10. Are not willing to provide small finger prick blood samples throughout the testing phases 11. Current participation in any other trials involving investigational or marketed products within 30 days prior to the practice day. 12. History of head injury/stroke 13. Any clinically relevant abnormalities in a volunteer’s medical history, physical examination, or results of laboratory tests.
Outcome results
None listed