The Effects of Specialty Coffee on Cognitive Function in People With Type 2 Diabetes
The Effects of CGA-rich Coffee on Cognitive Function in Type 2 Diabetes: A Parallel Groups Randomised Controlled Trial
1 other identifier
interventional
70
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable type-2-diabetes
Started Jan 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 11, 2022
CompletedStudy Start
First participant enrolled
January 1, 2023
CompletedFirst Posted
Study publicly available on registry
February 2, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2025
CompletedFebruary 2, 2023
January 1, 2023
2 years
November 11, 2022
January 24, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (20)
Haemoglobin A1C
8 weeks
Haemoglobin A1C
0 weeks
Haemoglobin A1C
-4 weeks
Lipid panel (total cholesterol, HDL, LDL, triglycerides)
8 weeks
Lipid panel (total cholesterol, HDL, LDL, triglycerides)
0 weeks
- +15 more secondary outcomes
Study Arms (2)
Conventional coffee
ACTIVE COMPARATORParticipants will be provided with a conventional, low CGA coffee to brew and consume which contains less CGA than the experimental arm.
CGA-rich coffee (Speciality coffee)
EXPERIMENTALParticipants 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
Interventions
24 ounces of coffee will be consumed daily
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kaiser Permanente
Berkeley, California, 94710, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel Lamport, PhD
University of Reading
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor Daniel Lamport
Study Record Dates
First Submitted
November 11, 2022
First Posted
February 2, 2023
Study Start
January 1, 2023
Primary Completion
January 1, 2025
Study Completion
January 1, 2025
Last Updated
February 2, 2023
Record last verified: 2023-01