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

Primary Purpose

Type 2 Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Coffee
Sponsored by
University of Reading
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Type 2 Diabetes

Eligibility Criteria

55 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Kaiser PermanenteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional coffee

CGA-rich coffee (Speciality coffee)

Arm Description

Participants will be provided with a conventional, low CGA coffee to brew and consume which contains less CGA than the experimental arm.

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

Outcomes

Primary Outcome Measures

Verbal memory
Assessed at the end of 8-week intervention arm using a modified version of the Rey Auditory Verbal Learning Test
Verbal memory
Assessed at the beginning of the 8-week intervention arm using a modified version of the Rey Auditory Verbal Learning Test
Verbal memory
Assessed at the beginning of the 4-week run-in period using a modified version of the Rey Auditory Verbal Learning Test

Secondary Outcome Measures

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

Full Information

First Posted
November 11, 2022
Last Updated
January 24, 2023
Sponsor
University of Reading
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1. Study Identification

Unique Protocol Identification Number
NCT05709847
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Reading

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional coffee
Arm Type
Active Comparator
Arm Description
Participants will be provided with a conventional, low CGA coffee to brew and consume which contains less CGA than the experimental arm.
Arm Title
CGA-rich coffee (Speciality coffee)
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Coffee
Intervention Description
24 ounces of coffee will be consumed daily
Primary Outcome Measure Information:
Title
Verbal memory
Description
Assessed at the end of 8-week intervention arm using a modified version of the Rey Auditory Verbal Learning Test
Time Frame
8 weeks
Title
Verbal memory
Description
Assessed at the beginning of the 8-week intervention arm using a modified version of the Rey Auditory Verbal Learning Test
Time Frame
0 weeks
Title
Verbal memory
Description
Assessed at the beginning of the 4-week run-in period using a modified version of the Rey Auditory Verbal Learning Test
Time Frame
-4 weeks
Secondary Outcome Measure Information:
Title
Haemoglobin A1C
Description
Self-reported by the participant at the end of the 8-week intervention arm
Time Frame
8 weeks
Title
Haemoglobin A1C
Description
Self-reported by the participant at the beginning of the 8-week intervention arm
Time Frame
0 weeks
Title
Haemoglobin A1C
Description
Self-reported by the participant at the beginning of the 4-week run-in period
Time Frame
-4 weeks
Title
Lipid panel (total cholesterol, HDL, LDL, triglycerides)
Description
Self-reported by the participant at the end of the 8-week intervention arm
Time Frame
8 weeks
Title
Lipid panel (total cholesterol, HDL, LDL, triglycerides)
Description
Self-reported by the participant at the beginning of the 8-week intervention arm
Time Frame
0 weeks
Title
Lipid panel (total cholesterol, HDL, LDL, triglycerides)
Description
Self-reported by the participant at the beginning of the 4-week run-in period
Time Frame
-4 weeks
Title
Depression symptoms
Description
Assessed at the end of the 8-week intervention arm with the PHQ-9
Time Frame
8 weeks
Title
Depression symptoms
Description
Assessed at the beginning of the 8-week intervention arm with the PHQ-9
Time Frame
0 weeks
Title
Depression symptoms
Description
Assessed at the beginning of the 4-week run-in period with the PHQ-9
Time Frame
-4 weeks
Title
Anxiety symptoms
Description
Assessed at the end of the 8-week intervention arm with the GAD-7
Time Frame
8 weeks
Title
Anxiety symptoms
Description
Assessed at the beginning of the 8-week intervention arm with the GAD-7
Time Frame
0 weeks
Title
Anxiety symptoms
Description
Assessed at the beginning of the 4-week run-in period with the GAD-7
Time Frame
-4 weeks
Title
Executive Function
Description
Assessed at the end of the 8-week intervention arm with a computerised version of the Corsi Block Tapping Test
Time Frame
8 weeks
Title
Executive Function
Description
Assessed at the beginning of the 8-week intervention arm with a computerised version of the Corsi Block Tapping Test
Time Frame
0 weeks
Title
Executive Function
Description
Assessed at the beginning of the 4-week run-in with a computerised version of the Corsi Block Tapping Test
Time Frame
-4 weeks
Title
Working memory
Description
Assessed at the beginning of the 8-week intervention arm with a computerised version of digit span
Time Frame
0 weeks
Title
Working memory
Description
Assessed at the beginning of the 4-week run-in with a computerised version of digit span
Time Frame
-4 weeks
Title
Processing Speed
Description
Assessed at the end of the 8-week intervention arm with a computerised version of the Digit Symbol Substitution Test
Time Frame
8 weeks
Title
Processing Speed
Description
Assessed at the beginning of the 8-week intervention arm with a computerised version of the Digit Symbol Substitution Test
Time Frame
0 weeks
Title
Processing Speed
Description
Assessed at the beginning of 4-week run-in with a computerised version of the Digit Symbol Substitution Test
Time Frame
-4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel J Lamport, PhD
Phone
+44 (0)1183785032
Email
daniel.lamport@reading.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Lamport, PhD
Organizational Affiliation
University of Reading
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente
City
Berkeley
State/Province
California
ZIP/Postal Code
94710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen Johal
Email
k.johal@pgr.reading.ac.uk

12. IPD Sharing Statement

Learn more about this trial

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

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