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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05709847
• Other study ID #: UReading Coffee Diabetes Study
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: January 1, 2025

Study information

• Verified date: January 2023
• Source: University of Reading
• Contact: Daniel J Lamport, PhD
• Phone: +44 (0)1183785032
• Email: daniel.lamport[@]reading.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Other:
• Coffee
24 ounces of coffee will be consumed daily

Locations

Country	Name	City	State
United States	Kaiser Permanente	Berkeley	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Reading

Country where clinical trial is conducted

United States, 

Outcome

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