NCT05119153

Brief Summary

The present study determined the effects light, medium, and dark roasted, brewed coffees on blood glucose responses in normal (n = 19) subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2019

Typical duration for not_applicable

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 5, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 12, 2021

Completed
Last Updated

November 12, 2021

Status Verified

November 1, 2021

Enrollment Period

1.1 years

First QC Date

October 31, 2021

Last Update Submit

November 10, 2021

Conditions

Keywords

coffeeglucose challengeblood glucose levels

Outcome Measures

Primary Outcomes (1)

  • Changes in Blood Glucose

    Each week, fasted baseline and postprandial measurements taken out to 240 minutes

    6 weeks

Secondary Outcomes (1)

  • Changes in Glucose Area Under the Curve

    6 weeks

Study Arms (4)

Placebo Comparator

PLACEBO COMPARATOR

Placebo composed of water and caramel color.

Dietary Supplement: Placebo Comparator

Light Roasted Coffee

EXPERIMENTAL

12 oz light roast coffee beverage prepared at 55 g ground coffee/L water

Dietary Supplement: Light Roasted Coffee

Medium Roasted Coffee

EXPERIMENTAL

12 oz medium roast coffee beverage prepared at 55 g ground coffee/L water

Dietary Supplement: Medium Roasted Coffee

Dark Roasted Coffee

EXPERIMENTAL

12 oz dark roast coffee beverage prepared at 55 g ground coffee/L water

Dietary Supplement: Dark Roasted Coffee

Interventions

Placebo ComparatorDIETARY_SUPPLEMENT

Placebo designed to mimic coffee color.

Placebo Comparator
Light Roasted CoffeeDIETARY_SUPPLEMENT

12 oz light roast coffee

Light Roasted Coffee
Medium Roasted CoffeeDIETARY_SUPPLEMENT

12 oz medium roast coffee

Medium Roasted Coffee
Dark Roasted CoffeeDIETARY_SUPPLEMENT

12 oz dark roast coffee

Dark Roasted Coffee

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-64 years old with BMI less than 29 and fasting blood glucose less than 125 mg/dl.

You may not qualify if:

  • Age 18-64 years old with BMI less than 29 and fasting blood glucose less than 125 mg/dl.
  • Weight less than 110 pounds (55 kg)
  • Pre-existing health conditions, such as:
  • High cholesterol
  • Hypertension
  • Cardiovascular disease
  • Gastrointestinal motility disorders
  • Hypo- or hyperthyroidism
  • Anemia
  • Renal disease
  • Liver disease, including hepatitis B or C, cholestasis, cirrhotic liver disease, or non-alcoholic fatty liver disease
  • Chronic or acute pancreatitis
  • Diabetes type 1 or 2
  • Insulin resistance
  • Polycystic ovary syndrome
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schaub Hall, Campus Box 7624

Raleigh, North Carolina, 27695, United States

Location

Related Publications (1)

  • Rayo-Mendez LM, Kinzer C, McMahon J, Nguyen M, Harris GK. Coffee Roast Level, Timing, and Carbohydrate Source Affect Peak Blood Glucose and Area Under the Curve Values in a Randomized Pilot Clinical Trial. J Nutr Metab. 2025 Oct 23;2025:4174563. doi: 10.1155/jnme/4174563. eCollection 2025.

MeSH Terms

Conditions

Hyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Gabriel K Harris, PhD

    North Carolina State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Subjects provided placebo and coffee beverages in a color coded bottles
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Randomized, single-blinded, partial block, crossover design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Food Science

Study Record Dates

First Submitted

October 31, 2021

First Posted

November 12, 2021

Study Start

November 5, 2019

Primary Completion

December 20, 2020

Study Completion

October 31, 2021

Last Updated

November 12, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Investigators do not plan to share IPD.

Locations