- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05119153
Effects of Coffee Roasting on Blood Sugar Levels in Healthy Humans
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
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Raleigh, North Carolina, United States, 27695
- Schaub Hall, Campus Box 7624
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo Comparator
Placebo composed of water and caramel color.
|
Placebo designed to mimic coffee color.
|
Experimental: Light Roasted Coffee
12 oz light roast coffee beverage prepared at 55 g ground coffee/L water
|
12 oz light roast coffee
|
Experimental: Medium Roasted Coffee
12 oz medium roast coffee beverage prepared at 55 g ground coffee/L water
|
12 oz medium roast coffee
|
Experimental: Dark Roasted Coffee
12 oz dark roast coffee beverage prepared at 55 g ground coffee/L water
|
12 oz dark roast coffee
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Blood Glucose
Time Frame: 6 weeks
|
Each week, fasted baseline and postprandial measurements taken out to 240 minutes
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Glucose Area Under the Curve
Time Frame: 6 weeks
|
Used glucose changes over 240 minutes to construct area under the curve
|
6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gabriel K Harris, PhD, North Carolina State University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16857
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.
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