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Effects of Coffee Roasting on Blood Sugar Levels in Healthy Humans

Primary Purpose

Hyperglycemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Placebo Comparator
Light Roasted Coffee
Medium Roasted Coffee
Dark Roasted Coffee
Sponsored by
North Carolina State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hyperglycemia focused on measuring coffee, glucose challenge, blood glucose levels

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  • Food allergies or intolerances to coffee/caffeine/dairy/corn-based cereals.
  • Currently taking prescription medication
  • Current smoker
  • Consumes more than 3 alcoholic beverages per day
  • Pregnant or breastfeeding
  • Not willing to take their own blood samples with finger sticks

Sites / Locations

  • Schaub Hall, Campus Box 7624

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Placebo Comparator

Light Roasted Coffee

Medium Roasted Coffee

Dark Roasted Coffee

Arm Description

Placebo composed of water and caramel color.

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

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

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

Outcomes

Primary Outcome Measures

Changes in Blood Glucose
Each week, fasted baseline and postprandial measurements taken out to 240 minutes

Secondary Outcome Measures

Changes in Glucose Area Under the Curve
Used glucose changes over 240 minutes to construct area under the curve

Full Information

First Posted
October 31, 2021
Last Updated
November 10, 2021
Sponsor
North Carolina State University
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1. Study Identification

Unique Protocol Identification Number
NCT05119153
Brief Title
Effects of Coffee Roasting on Blood Sugar Levels in Healthy Humans
Official Title
Effects of Coffee Roasting on Blood Sugar Levels in Healthy Humans
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
November 5, 2019 (Actual)
Primary Completion Date
December 20, 2020 (Actual)
Study Completion Date
October 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
North Carolina State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The present study determined the effects light, medium, and dark roasted, brewed coffees on blood glucose responses in normal (n = 19) subjects.
Detailed Description
This is a single-blinded, randomized partial block design conducted over 6 weeks in two parts. In part 1 (3 weeks), participants were randomly assigned to consume four beverages: a placebo containing water and caramel color, light, medium, or dark roast coffee before, during, or after consumption of a beverage containing 50 g of glucose. In part 2 (3 weeks), participants were randomly assigned to consume four beverages: a placebo containing water and caramel color, light, medium, or dark roast coffee before, during, or after consumption of a standardized breakfast (corn flakes cereal + skim milk) containing 50 g of glucose. In each part, fasting and postprandial glucose profiles were determined.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperglycemia
Keywords
coffee, glucose challenge, blood glucose levels

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized, single-blinded, partial block, crossover design
Masking
Participant
Masking Description
Subjects provided placebo and coffee beverages in a color coded bottles
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo Comparator
Arm Type
Placebo Comparator
Arm Description
Placebo composed of water and caramel color.
Arm Title
Light Roasted Coffee
Arm Type
Experimental
Arm Description
12 oz light roast coffee beverage prepared at 55 g ground coffee/L water
Arm Title
Medium Roasted Coffee
Arm Type
Experimental
Arm Description
12 oz medium roast coffee beverage prepared at 55 g ground coffee/L water
Arm Title
Dark Roasted Coffee
Arm Type
Experimental
Arm Description
12 oz dark roast coffee beverage prepared at 55 g ground coffee/L water
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo Comparator
Intervention Description
Placebo designed to mimic coffee color.
Intervention Type
Dietary Supplement
Intervention Name(s)
Light Roasted Coffee
Intervention Description
12 oz light roast coffee
Intervention Type
Dietary Supplement
Intervention Name(s)
Medium Roasted Coffee
Intervention Description
12 oz medium roast coffee
Intervention Type
Dietary Supplement
Intervention Name(s)
Dark Roasted Coffee
Intervention Description
12 oz dark roast coffee
Primary Outcome Measure Information:
Title
Changes in Blood Glucose
Description
Each week, fasted baseline and postprandial measurements taken out to 240 minutes
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Changes in Glucose Area Under the Curve
Description
Used glucose changes over 240 minutes to construct area under the curve
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: • Age 18-64 years old with BMI less than 29 and fasting blood glucose less than 125 mg/dl. Exclusion Criteria: 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 Food allergies or intolerances to coffee/caffeine/dairy/corn-based cereals. Currently taking prescription medication Current smoker Consumes more than 3 alcoholic beverages per day Pregnant or breastfeeding Not willing to take their own blood samples with finger sticks
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabriel K Harris, PhD
Organizational Affiliation
North Carolina State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Schaub Hall, Campus Box 7624
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27695
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Investigators do not plan to share IPD.

Learn more about this trial

Effects of Coffee Roasting on Blood Sugar Levels in Healthy Humans

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