Type 2 DiabetesNCT05709847
The Effects of Specialty Coffee on Cognitive Function in People With Type 2 Diabetes
A study testing Coffee in people with Type 2 Diabetes, run by University of Reading at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 55 to 70 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Coffee
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2023to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Kaiser Permanente
Berkeley, California, 94710
Karen Johal, k.johal@pgr.reading.ac.uk
About this study
Official title: 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.
- Conditions
- Type 2 Diabetes
- Being tested
- Coffee
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoffeeOther
24 ounces of coffee will be consumed daily
| Study group | Role | What they receive |
|---|---|---|
| Conventional coffee | Active comparator | Participants will be provided with a conventional, low CGA coffee to brew and consume which contains less CGA than the experimental arm. Receives: Other: Coffee |
| CGA-rich coffee (Speciality coffee) | Experimental | 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 Receives: Other: Coffee |
What is being measured
The primary outcome is the main question the study is designed to answer.
Verbal memory
Assessed at the end of 8-week intervention arm using a modified version of the Rey Auditory Verbal Learning Test
Measured: 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
Measured: 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
Measured: -4 weeks
Secondary outcomes (20)
Haemoglobin A1C
Self-reported by the participant at the end of the 8-week intervention arm
Measured: 8 weeks
Haemoglobin A1C
Self-reported by the participant at the beginning of the 8-week intervention arm
Measured: 0 weeks
Haemoglobin A1C
Self-reported by the participant at the beginning of the 4-week run-in period
Measured: -4 weeks
Lipid panel (total cholesterol, HDL, LDL, triglycerides)
Self-reported by the participant at the end of the 8-week intervention arm
Measured: 8 weeks
Lipid panel (total cholesterol, HDL, LDL, triglycerides)
Self-reported by the participant at the beginning of the 8-week intervention arm
Measured: 0 weeks
Lipid panel (total cholesterol, HDL, LDL, triglycerides)
Self-reported by the participant at the beginning of the 4-week run-in period
Measured: -4 weeks
Depression symptoms
Assessed at the end of the 8-week intervention arm with the PHQ-9
Measured: 8 weeks
Depression symptoms
Assessed at the beginning of the 8-week intervention arm with the PHQ-9
Measured: 0 weeks
Depression symptoms
Assessed at the beginning of the 4-week run-in period with the PHQ-9
Measured: -4 weeks
Anxiety symptoms
Assessed at the end of the 8-week intervention arm with the GAD-7
Measured: 8 weeks
Anxiety symptoms
Assessed at the beginning of the 8-week intervention arm with the GAD-7
Measured: 0 weeks
Anxiety symptoms
Assessed at the beginning of the 4-week run-in period with the GAD-7
Measured: -4 weeks
Executive Function
Assessed at the end of the 8-week intervention arm with a computerised version of the Corsi Block Tapping Test
Measured: 8 weeks
Executive Function
Assessed at the beginning of the 8-week intervention arm with a computerised version of the Corsi Block Tapping Test
Measured: 0 weeks
Executive Function
Assessed at the beginning of the 4-week run-in with a computerised version of the Corsi Block Tapping Test
Measured: -4 weeks
Working memory
Assessed at the beginning of the 8-week intervention arm with a computerised version of digit span
Measured: 0 weeks
Working memory
Assessed at the beginning of the 4-week run-in with a computerised version of digit span
Measured: -4 weeks
Processing Speed
Assessed at the end of the 8-week intervention arm with a computerised version of the Digit Symbol Substitution Test
Measured: 8 weeks
Processing Speed
Assessed at the beginning of the 8-week intervention arm with a computerised version of the Digit Symbol Substitution Test
Measured: 0 weeks
Processing Speed
Assessed at the beginning of 4-week run-in with a computerised version of the Digit Symbol Substitution Test
Measured: -4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start1 Jan 2023
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Lamport, University of Reading
- Investigators
- Daniel Lamport, PhD, Principal investigator, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05709847
- Sponsor's protocol ID
- UReading Coffee Diabetes Study
- Status last verified
- Jan 2023
- First submitted
- 11 Nov 2022
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of CGA-rich Coffee on Cognitive Function in Type 2 Diabetes: A Parallel Groups Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05709847
- Acronym / sponsor ID
- UReading Coffee Diabetes Study
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 2 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional coffee | Active comparator | Other: CoffeeParticipants will be provided with a conventional, low CGA coffee to brew and consume which contains less CGA than the experimental arm. |
| CGA-rich coffee (Speciality coffee) | Experimental | Other: CoffeeParticipants 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 |
Who may qualify
- Ages
- 55 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coffee24 ounces of coffee will be consumed daily | Other | CGA-rich coffee (Speciality coffee), Conventional coffee |
Primary outcome
Verbal memory
Time frame: 8 weeks
Assessed at the end of 8-week intervention arm using a modified version of the Rey Auditory Verbal Learning Test
Verbal memory
Time frame: 0 weeks
Assessed at the beginning of the 8-week intervention arm using a modified version of the Rey Auditory Verbal Learning Test
Verbal memory
Time frame: -4 weeks
Assessed at the beginning of the 4-week run-in period using a modified version of the Rey Auditory Verbal Learning Test
20 secondary outcomes
Haemoglobin A1C
Time frame: 8 weeks
Haemoglobin A1C
Time frame: 0 weeks
Haemoglobin A1C
Time frame: -4 weeks
Lipid panel (total cholesterol, HDL, LDL, triglycerides)
Time frame: 8 weeks
Lipid panel (total cholesterol, HDL, LDL, triglycerides)
Time frame: 0 weeks
Lipid panel (total cholesterol, HDL, LDL, triglycerides)
Time frame: -4 weeks
Depression symptoms
Time frame: 8 weeks
Depression symptoms
Time frame: 0 weeks
Depression symptoms
Time frame: -4 weeks
Anxiety symptoms
Time frame: 8 weeks
Anxiety symptoms
Time frame: 0 weeks
Anxiety symptoms
Time frame: -4 weeks
Executive Function
Time frame: 8 weeks
Executive Function
Time frame: 0 weeks
Executive Function
Time frame: -4 weeks
Working memory
Time frame: 0 weeks
Working memory
Time frame: -4 weeks
Processing Speed
Time frame: 8 weeks
Processing Speed
Time frame: 0 weeks
Processing Speed
Time frame: -4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Lamport, PhD principal investigator
University of Reading
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coffee in people with Type 2 Diabetes, run by University of Reading at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniel J Lamport, PhD (+44 (0)1183785032, daniel.lamport@reading.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Verbal memory (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2023.