The Effects of Specialty Coffee on Cognitive Function in People With Type 2 Diabetes

Study Overview
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Brief Summary
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Coffee has been found to have beneficial effects on cognitive function and blood sugar control. Benefits include reduced risk of cognitive decline and improved performance on cognitive tests, as well as reduced risk of diabetes and improved blood sugar control in people with diabetes, a population that is at a higher risk of cognitive decline. These effects have been observed for both caffeinated and decaffeinated coffee, and have been associated with the polyphenol chlorogenic acid (CGA). This polyphenol has been found to be more bioavailable in certain coffees, known as speciality coffee as defined by the Specialty Coffee Association of America, depending on agriculture, roasting, and brewing method. This current project will bring together these previous findings to explore the effects of specialty coffee on cognitive function and glycaemic control in people with type 2 diabetes through a randomized control trial with two groups: a high CGA specialty coffee group and a conventional coffee control group. Participants will be quasi-randomly assigned to one of these two groups following the completion of a 4-week run-in period during which participants will consume conventional coffee only. The length of the experimental arms is 8 weeks, therefore the total length of the study is 12 weeks. At the beginning and the end of each experimental arm participants will undertake a cognitive assessment online using the Gorilla platform, and a series of questionnaires relating to health and mood measures (details in procedure). Cognitive function will also be assessed at the beginning of the 4-week run-in period.

Official Title
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The Effects of CGA-rich Coffee on Cognitive Function in Type 2 Diabetes: A Parallel Groups Randomised Controlled Trial

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Other: Coffee


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 55-70 years Formal diagnosis of Type 2 Diabetes for 3 years or more Current coffee drinkers, 4 or fewer cups daily (a cup is 8 oz) Exclusion Criteria: Insulin-dependent Consuming on average more than 4 cups of coffee daily Regularly consuming specialty coffee (participants will be provided with a list of these coffees)

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional coffee<br>Participants will be provided with a conventional, low CGA coffee to brew and consume which contains less CGA than the experimental arm. | Other: Coffee<br>* 24 ounces of coffee will be consumed daily<br>|
| Experimental: CGA-rich coffee (Speciality coffee)<br>Participants will be provided with a single origin, CGA-rich specialty coffee as graded by the Specialty Coffee Association of America's Q-grading system to brew and consume | Other: Coffee<br>* 24 ounces of coffee will be consumed daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Verbal memory | Assessed at the end of 8-week intervention arm using a modified version of the Rey Auditory Verbal Learning Test | 8 weeks | 
| Verbal memory | Assessed at the beginning of the 8-week intervention arm using a modified version of the Rey Auditory Verbal Learning Test | 0 weeks | 
| Verbal memory | Assessed at the beginning of the 4-week run-in period using a modified version of the Rey Auditory Verbal Learning Test | -4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Haemoglobin A1C | Self-reported by the participant at the end of the 8-week intervention arm | 8 weeks | 
| Haemoglobin A1C | Self-reported by the participant at the beginning of the 8-week intervention arm | 0 weeks | 
| Haemoglobin A1C | Self-reported by the participant at the beginning of the 4-week run-in period | -4 weeks | 
| Lipid panel (total cholesterol, HDL, LDL, triglycerides) | Self-reported by the participant at the end of the 8-week intervention arm | 8 weeks | 
| Lipid panel (total cholesterol, HDL, LDL, triglycerides) | Self-reported by the participant at the beginning of the 8-week intervention arm | 0 weeks | 
| Lipid panel (total cholesterol, HDL, LDL, triglycerides) | Self-reported by the participant at the beginning of the 4-week run-in period | -4 weeks | 
| Depression symptoms | Assessed at the end of the 8-week intervention arm with the PHQ-9 | 8 weeks | 
| Depression symptoms | Assessed at the beginning of the 8-week intervention arm with the PHQ-9 | 0 weeks | 
| Depression symptoms | Assessed at the beginning of the 4-week run-in period with the PHQ-9 | -4 weeks | 
| Anxiety symptoms | Assessed at the end of the 8-week intervention arm with the GAD-7 | 8 weeks | 
| Anxiety symptoms | Assessed at the beginning of the 8-week intervention arm with the GAD-7 | 0 weeks | 
| Anxiety symptoms | Assessed at the beginning of the 4-week run-in period with the GAD-7 | -4 weeks | 
| Executive Function | Assessed at the end of the 8-week intervention arm with a computerised version of the Corsi Block Tapping Test | 8 weeks | 
| Executive Function | Assessed at the beginning of the 8-week intervention arm with a computerised version of the Corsi Block Tapping Test | 0 weeks | 
| Executive Function | Assessed at the beginning of the 4-week run-in with a computerised version of the Corsi Block Tapping Test | -4 weeks | 
| Working memory | Assessed at the beginning of the 8-week intervention arm with a computerised version of digit span | 0 weeks | 
| Working memory | Assessed at the beginning of the 4-week run-in with a computerised version of digit span | -4 weeks | 
| Processing Speed | Assessed at the end of the 8-week intervention arm with a computerised version of the Digit Symbol Substitution Test | 8 weeks | 
| Processing Speed | Assessed at the beginning of the 8-week intervention arm with a computerised version of the Digit Symbol Substitution Test | 0 weeks | 
| Processing Speed | Assessed at the beginning of 4-week run-in with a computerised version of the Digit Symbol Substitution Test | -4 weeks |