Clinical trial NCT05709847: The Effects of Specialty Coffee on Cognitive Function in People With Type 2 Diabetes
Official title: The Effects of CGA-rich Coffee on Cognitive Function in Type 2 Diabetes: A Parallel Groups Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: University of Reading
Sponsor class: OTHER
First posted: 2023-02-02
Enrollment: 70
Sex: ALL
Minimum age (years): 55
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Verbal memory
timeFrame: 8 weeks
measure: Verbal memory
timeFrame: 0 weeks
measure: Verbal memory
timeFrame: -4 weeks
Secondary outcomes:
measure: Haemoglobin A1C
timeFrame: 8 weeks
measure: Haemoglobin A1C
timeFrame: 0 weeks
measure: Haemoglobin A1C
timeFrame: -4 weeks
measure: Lipid panel (total cholesterol, HDL, LDL, triglycerides)
timeFrame: 8 weeks
measure: Lipid panel (total cholesterol, HDL, LDL, triglycerides)
timeFrame: 0 weeks
measure: Lipid panel (total cholesterol, HDL, LDL, triglycerides)
timeFrame: -4 weeks
measure: Depression symptoms
timeFrame: 8 weeks
measure: Depression symptoms
timeFrame: 0 weeks
measure: Depression symptoms
timeFrame: -4 weeks
measure: Anxiety symptoms
timeFrame: 8 weeks
measure: Anxiety symptoms
timeFrame: 0 weeks
measure: Anxiety symptoms
timeFrame: -4 weeks
measure: Executive Function
timeFrame: 8 weeks
measure: Executive Function
timeFrame: 0 weeks
measure: Executive Function
timeFrame: -4 weeks
measure: Working memory
timeFrame: 0 weeks
measure: Working memory
timeFrame: -4 weeks
measure: Processing Speed
timeFrame: 8 weeks
measure: Processing Speed
timeFrame: 0 weeks
measure: Processing Speed
timeFrame: -4 weeks
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: Kaiser Permanente
state: California
Study officials:
affiliation: University of Reading
name: Daniel Lamport, PhD
role: PRINCIPAL_INVESTIGATOR
References: