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
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.
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
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.
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Berkeley, California, United States, 94720
- Berkeley
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 30 years or more
- Formal diagnosis of Type 2 Diabetes for 1 year or more
- Current coffee drinkers, 4 or fewer cups daily (a cup is 8 oz)
Exclusion Criteria:
- Consuming on average more than 5 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: Crossover Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Active Comparator: Low Polyphenol coffee
Participants will be provided with a conventional, low CGA coffee to brew and consume which contains less CGA than the experimental arm.
|
12 ounces of coffee will be consumed
|
|
Experimental: High Polyphenol 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
|
12 ounces of coffee will be consumed
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Short term Memory
Time Frame: 0 hours
|
The Rey Auditory Verbal Learning Test (RAVLT) will present two lists of 15 words each, which will be played via audio recording after which participants will be asked to recite as many words as they can remember.
|
0 hours
|
|
Short term Memory
Time Frame: 0 hours
|
The Digit Span Forward Task will show a series of numbers in a specific order which participants will be asked to type out in the order shown
|
0 hours
|
|
Short term Memory
Time Frame: 0 hours
|
The Corsi Block Tapping task will present participants with a screen of blocks that light up in a sequence which participants will have to remember and tap the blocks in the order shown; the sequence lengthens or shortens based on participants performance.
|
0 hours
|
|
Processing Speed
Time Frame: 0 hours
|
A computerised version of the Digit Symbol Substitution Test (DSST) will be used to assess processing speed.
Participants will be given a legend with numbers corresponding to symbols, then presented with a specific pair of number/symbol.
They will then determine if that pair is a match or a mismatch, and respond accordingly.
They will be measured for speed and accuracy.
|
0 hours
|
|
Processing Speed
Time Frame: 5 hours
|
A computerised version of the Digit Symbol Substitution Test (DSST) will be used to assess processing speed.
Participants will be given a legend with numbers corresponding to symbols, then presented with a specific pair of number/symbol.
They will then determine if that pair is a match or a mismatch, and respond accordingly.
They will be measured for speed and accuracy.
|
5 hours
|
|
Processing Speed
Time Frame: 24 hours
|
A computerised version of the Digit Symbol Substitution Test (DSST) will be used to assess processing speed.
Participants will be given a legend with numbers corresponding to symbols, then presented with a specific pair of number/symbol.
They will then determine if that pair is a match or a mismatch, and respond accordingly.
They will be measured for speed and accuracy.
|
24 hours
|
|
Long Term Memory
Time Frame: 0 hours
|
Long term memory will be assessed using the Rey Auditory Verbal Learning Test (RAVLT), where participants will be asked to recall as many words as possible from the previous two lists words heard earlier.
|
0 hours
|
|
Long Term Memory
Time Frame: 5 hours
|
Long term memory will be assessed using the Rey Auditory Verbal Learning Test (RAVLT), where participants will be asked to recall as many words as possible from the previous two lists words heard earlier.
|
5 hours
|
|
Long Term Memory
Time Frame: 24 hours
|
Long term memory will be assessed using the Rey Auditory Verbal Learning Test (RAVLT), where participants will be asked to recall as many words as possible from the previous two lists words heard earlier.
|
24 hours
|
|
Source Monitoring
Time Frame: 0 hours
|
Source monitoring will be assessed using a modified version of the Rey Auditory Verbal Learning Test (RAVLT) where a third "distractor" list will be presented, after which participants will be asked to recognize if a word is one heard in the original two lists, or a new word.
If participants respond the former, they will then be asked to identify which list they heard the word from.
|
0 hours
|
|
Source Monitoring
Time Frame: 5 hours
|
Source monitoring will be assessed using a modified version of the Rey Auditory Verbal Learning Test (RAVLT) where a third "distractor" list will be presented, after which participants will be asked to recognize if a word is one heard in the original two lists, or a new word.
If participants respond the former, they will then be asked to identify which list they heard the word from.
|
5 hours
|
|
Source Monitoring
Time Frame: 24 hours
|
Source monitoring will be assessed using a modified version of the Rey Auditory Verbal Learning Test (RAVLT) where a third "distractor" list will be presented, after which participants will be asked to recognize if a word is one heard in the original two lists, or a new word.
If participants respond the former, they will then be asked to identify which list they heard the word from.
|
24 hours
|
|
Short term Memory
Time Frame: 5 hours
|
The Rey Auditory Verbal Learning Test (RAVLT) will present two lists of 15 words each, which will be played via audio recording after which participants will be asked to recite as many words as they can remember.
|
5 hours
|
|
Short term Memory
Time Frame: 5 hours
|
The Corsi Block Tapping task will present participants with a screen of blocks that light up in a sequence which participants will have to remember and tap the blocks in the order shown; the sequence lengthens or shortens based on participants performance.
|
5 hours
|
|
Short term Memory
Time Frame: 5 hours
|
The Digit Span Forward Task will show a series of numbers in a specific order which participants will be asked to type out in the order shown
|
5 hours
|
|
Short term Memory
Time Frame: 24 hours
|
The Rey Auditory Verbal Learning Test (RAVLT) will present two lists of 15 words each, which will be played via audio recording after which participants will be asked to recite as many words as they can remember.
|
24 hours
|
|
Short term Memory
Time Frame: 24 hours
|
The Digit Span Forward Task will show a series of numbers in a specific order which participants will be asked to type out in the order shown
|
24 hours
|
|
Short term Memory
Time Frame: 24 hours
|
The Corsi Block Tapping task will present participants with a screen of blocks that light up in a sequence which participants will have to remember and tap the blocks in the order shown; the sequence lengthens or shortens based on participants performance.
|
24 hours
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mood
Time Frame: 0 hours
|
Positive affect will be measured using the Positive and Negative Affect Schedule (PANAS).
The ratings (a scale of 1-5) for the 10 positive items will be summed to get a Positive Affect (PA) score.
Scores can range from 10 to 50, with higher scores indicated higher levels of PA
|
0 hours
|
|
Mood
Time Frame: 0 hours
|
Negative affect will be measured using the Positive and Negative Affect Schedule (PANAS).
The ratings (a scale of 1-5) for the 10 negative items will be summed to get a Negative Affect (NA) score.
Scores can range from 10 to 50, with higher scores indicated higher levels of PA
|
0 hours
|
|
Mood
Time Frame: 0 hours
|
Mood will be measured using the Bond-Lader Visual Analogue Scale (BL-VAS) where participants rate their mood by marking a continuous line between two extreme endpoints, typically ranging from "not at all" to "extremely."
The values are averaged into three categories (alertness, contentedness, and calmness) and higher scores indicate higher experiencing of each category.
|
0 hours
|
|
Mood
Time Frame: 0 hours
|
Mood will be measured using the Immediate Mood Scaler (IMS), which captures current mood states using 7-point Likert scales.
The total score is calculated by summing all 22 items, with higher scores indicating more negative mood states
|
0 hours
|
|
Mood
Time Frame: 5 hours
|
Positive affect will be measured using the Positive and Negative Affect Schedule (PANAS).
The ratings (a scale of 1-5) for the 10 positive items will be summed to get a Positive Affect (PA) score.
Scores can range from 10 to 50, with higher scores indicated higher levels of PA
|
5 hours
|
|
Mood
Time Frame: 5 hours
|
Negative affect will be measured using the Positive and Negative Affect Schedule (PANAS).
The ratings (a scale of 1-5) for the 10 negative items will be summed to get a Negative Affect (NA) score.
Scores can range from 10 to 50, with higher scores indicated higher levels of PA
|
5 hours
|
|
Mood
Time Frame: 5 hours
|
Mood will be measured using the Bond-Lader Visual Analogue Scale (BL-VAS) where participants rate their mood by marking a continuous line between two extreme endpoints, typically ranging from "not at all" to "extremely."
The values are averaged into three categories (alertness, contentedness, and calmness) and higher scores indicate higher experiencing of each category.
|
5 hours
|
|
Mood
Time Frame: 5 hours
|
Mood will be measured using the Immediate Mood Scaler (IMS), which captures current mood states using 7-point Likert scales.
The total score is calculated by summing all 22 items, with higher scores indicating more negative mood states
|
5 hours
|
|
Mood
Time Frame: 24 hours
|
Positive affect will be measured using the Positive and Negative Affect Schedule (PANAS).
The ratings (a scale of 1-5) for the 10 positive items will be summed to get a Positive Affect (PA) score.
Scores can range from 10 to 50, with higher scores indicated higher levels of PA
|
24 hours
|
|
Mood
Time Frame: 24 hours
|
Negative affect will be measured using the Positive and Negative Affect Schedule (PANAS).
The ratings (a scale of 1-5) for the 10 negative items will be summed to get a Negative Affect (NA) score.
Scores can range from 10 to 50, with higher scores indicated higher levels of PA
|
24 hours
|
|
Mood
Time Frame: 24 hours
|
Mood will be measured using the Bond-Lader Visual Analogue Scale (BL-VAS) where participants rate their mood by marking a continuous line between two extreme endpoints, typically ranging from "not at all" to "extremely."
The values are averaged into three categories (alertness, contentedness, and calmness) and higher scores indicate higher experiencing of each category.
|
24 hours
|
|
Mood
Time Frame: 24 hours
|
Mood will be measured using the Immediate Mood Scaler (IMS), which captures current mood states using 7-point Likert scales.
The total score is calculated by summing all 22 items, with higher scores indicating more negative mood states
|
24 hours
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- UReading Acute Coffee Diabetes
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Type 2 Diabetes
-
NCT07148713RecruitingType 2 Diabetes | Nutrition | Diabetes Type 2 | T2DM (Type 2 Diabetes Mellitus) | Diabetes Mellitis | T2DM | Diabetes Education
-
NCT06906653Enrolling by invitationType 2 Diabetes | Type 2 Diabetes Mellitus (T2DM) | Type 2 Diabetes (T2D)
-
NCT07197788Not yet recruitingDiabetes Mellitus, Type 2 | Diabetes | Type 2 Diabetes Mellitus | Type 2 Diabetes | Type2diabetes
-
NCT07622628RecruitingType 2 Diabetes | Diabetes Mellitus Type 2
-
NCT07636161Not yet recruitingType 2 Diabetes | Type 2 Diabetes (T2DM)
-
NCT07197775Not yet recruitingDiabetes Mellitus, Type 2 | Diabetes | Type 2 Diabetes | Type 2 Diabetes Mellitus (T2DM) | Type2Diabetes
-
NCT06616779CompletedType 2 Diabetes | Type 2 Diabetes Mellitus (T2DM) | Type 2 Diabetes, Insulin Requiring
-
NCT06856720Enrolling by invitationType 2 Diabetes Mellitus | Aging | Hyperglycemia Due to Type 2 Diabetes Mellitus
-
NCT07493707Active, not recruiting
-
NCT07167004RecruitingType 2 Diabetes Mellitus | Type 2 Diabetes | Type II Diabetes Mellitus | Pre-diabetes | Pre-diabetic | Type II Diabetes | Type 2 Diabetes Mellitus (T2DM) | Type 2 Diabetes (T2DM) | Pre-diabetic State
Clinical Trials on Coffee
-
NCT05121519CompletedAtrial Fibrillation | Coffee
-
NCT04307979UnknownInflammatory Response | Cognitive Function | Leukocytosis | Triglycerides
-
NCT03495336CompletedCardiovascular Diseases
-
NCT02639728Completed
-
NCT07641335Not yet recruitingCognitive Performance | Caffeine | Reaction Time | Attention
-
NCT05136495CompletedADCY5-related Dyskinesia
-
NCT01364207CompletedPrimary Open Angle Glaucoma