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

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.

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Other: Coffee

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniel J Lamport, PhD; Phone Number: +44 (0)1183785032; Email: daniel.lamport@reading.ac.uk

Study Locations

• United States
  • California
    • Berkeley, California, United States, 94710
      • Recruiting
      • Kaiser Permanente
      • Contact: Karen Johal; Email: k.johal@pgr.reading.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Conventional coffee; Participants will be provided with a conventional, low CGA coffee to brew and consume which contains less CGA than the experimental arm.	Other: Coffee; 24 ounces of coffee will be consumed daily
EXPERIMENTAL: CGA-rich coffee (Speciality coffee); 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; 24 ounces of coffee will be consumed daily

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Reading
• Investigators: Principal Investigator: Daniel Lamport, PhD, University of Reading

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2023
• Primary Completion (ANTICIPATED): January 1, 2025
• Study Completion (ANTICIPATED): January 1, 2025

Study Registration Dates

• First Submitted: November 11, 2022
• First Submitted That Met QC Criteria: January 24, 2023
• First Posted (ACTUAL): February 2, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 2, 2023
• Last Update Submitted That Met QC Criteria: January 24, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: UReading Coffee Diabetes Study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No