Trials / Completed
CompletedNCT07420699
The Acute Effects of Specialty Coffee on Cognitive Function in People With Type 2 Diabetes
The Effects of Drinking Specialty Coffee on Cognition in People With Type 2 Diabetes
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- University of Reading · Academic / Other
- Sex
- All
- Age
- 30 Years
- Healthy volunteers
- Not accepted
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 in people with type 2 diabetes through a repeated measures trial with two conditions: a high CGA specialty coffee group and a conventional coffee control group. Participants will consume each beverage 1 week apart and will be tested before consumption, 5 hours after consumption, and 24 hours after consumption based on findings that CGA metabolism takes up to 36 hours. At the beginning and the end of each condition 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). In regard to key ethical issues, all participants will be coffee consumers therefore participants will be accustomed to consuming coffee and no adverse events are expected. The quantities of coffee to be consumed do not exceed the recommended daily intake of caffeine. The study will not impact on the participants ongoing management of their type 2 diabetes. Participants will be free to withdraw from the study any point without giving reason.
Detailed description
Following recruitment, interested participants will undertake an online screening session with the experimenter to check the inclusion and exclusion criteria (see section 3). Following this, study procedures will be explained in full by the experimenter and the participants will receive the information sheet (by email) and complete the consent form online. At this point, demographic information and chronic mood measures (BDI and GAD-7) will be collected. At the screening session participants will also undertake a practice version of the online cognitive tests, acute mood measure questionnaires, and an online 24 hour diet recall (ASA24) for familiarisation. The cognitive tests will include digit span text entry, the digit symbol substitution task, Corsi blocks, and an auditory verbal learning test (AVLT). The standardised acute mood measures include the PANAS (outcome measures Positive and Negative Affect) and the Bond-Lader questionnaire (outcome measures alertness, attentiveness, and calmness). These will be adapted for online completion using the Gorilla platform. If able, participants will also self-report the following data relating to their glucose control and cardiovascular health to help characterise the sample: lipid panel (total cholesterol, HDL, LDL, and triglycerides) and HbA1C. Participants will have access this data from their routine type 2 diabetes consultations. On test days, participants will log onto a video conference to meet with the researcher. They will complete the ASA24, cognitive battery, and acute mood measure questionnaires. Then participants will consume the provided coffee within 30 minutes. Participants will have either collected this coffee or have it posted to them alongside brewing equipment, standardised instructions for preparing, and a video demonstrating how to brew the coffee and use the equipment. Patients will log off the video call and will log back on 5 hours after finishing their coffee to undertake the cognitive battery and acute mood measures. No other coffee consumption is permitted during this time and participants will be instructed to consume a lunch low in CGA guided by a list of foods to avoid. They will log back on 24 hours after finishing their coffee to complete the cognitive battery and acute mood measures for the third and final time. For the third time point, participants will be instructed to consume the same breakfast and any coffee they had prior to meeting with the researcher at the first time point; coffee will be permitted in this instance to avoid withdrawal. Upon completing the intervention, participants will be posed questions to explore attitudes about coffee drinking and blood sugar management.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Coffee | 12 ounces of coffee will be consumed |
Timeline
- Start date
- 2023-11-09
- Primary completion
- 2024-08-23
- Completion
- 2024-08-23
- First posted
- 2026-02-19
- Last updated
- 2026-02-19
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT07420699. Inclusion in this directory is not an endorsement.