NCT07420699

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 9, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2024

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

February 19, 2026

Completed
Last Updated

February 19, 2026

Status Verified

February 1, 2026

Enrollment Period

10 months

First QC Date

February 20, 2024

Last Update Submit

February 11, 2026

Conditions

Outcome Measures

Primary Outcomes (18)

  • Short term Memory

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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 Outcomes (12)

  • Mood

    0 hours

  • Mood

    0 hours

  • Mood

    0 hours

  • Mood

    0 hours

  • Mood

    5 hours

  • +7 more secondary outcomes

Study Arms (2)

Low Polyphenol 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.

Other: Coffee

High Polyphenol 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

Other: Coffee

Interventions

CoffeeOTHER

12 ounces of coffee will be consumed

High Polyphenol coffeeLow Polyphenol coffee

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Consuming on average more than 5 cups of coffee daily
  • Regularly consuming specialty coffee (participants will be provided with a list of these coffees)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Berkeley

Berkeley, California, 94720, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Coffee

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Plant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 20, 2024

First Posted

February 19, 2026

Study Start

November 9, 2023

Primary Completion

August 23, 2024

Study Completion

August 23, 2024

Last Updated

February 19, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

Locations