- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02417519
Coffee Roasting and Glucose Tolerance
Acute Effects of Light and Dark Roasted Coffee on Glucose Tolerance: A Randomized, Controlled Crossover Trial in Healthy Volunteers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Epidemiologic evidence suggests that coffee consumption is associated with a lower risk of type 2 diabetes. Coffee contains caffeine and several other components that may modulate glucose regulation. The chlorogenic acids (CGA) in coffee have been indicated as constituents that may help to normalize the acute glucose response after a carbohydrate challenge. The aim of this study was to investigate whether two coffee beverages that differ in CGA content due to different roasting degrees will affect glucose regulation differently.
In a controlled crossover trial, 11 healthy fasted volunteers consumed 300 mL of either light roasted (LIR) or dark roasted (DAR) coffee, or water, followed 30 min later by a 75-g oral glucose tolerance test (OGTT). Blood samples were drawn at baseline, 30, 60 and 120 min. Differences in glucose and insulin responses and insulin sensitivity index (ISI) were analyzed. The CGA and caffeine contents in the coffees were analyzed using UPLC-MS/MS.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Frederiksberg, Denmark, 1958
- Department of Nutrition, Exercise and sports, University of Copenhagen
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Body mass index (BMI) of 18.0-30.0 kg/m2 and with no known diseases
Exclusion Criteria:
- systemic infections,
- psychiatric or metabolic disorders,
- known food allergies or intolerances related to the products used in the study (e.g. dairy or gluten),
- ongoing or former drug abuse,
- high intake of alcohol (defined as a weekly intake of >7 units for women and > 14 units for men),
- pregnancy or ongoing planning of pregnancy,
- vegetarianism or veganism,
- participation in other scientific studies during the study period, and
- blood donation during - or in the month leading up to - the study period
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Sequence A
The meal study was performed with dark roast coffee (DAR), light roast coffe (LIR), or water (CTR) in a random sequence.
Sequance A was DAR-LIR-CTR
|
Volunteers ingested 300 mL of coffee with a dark roast containing low levels of chlorogenic acids followed 30 min later by by 75g glucose and 300 mL water
Other Names:
Volunteers ingested 300 mL of coffee with a light roast containing high levels of chlorogenic acids followed 30 min later by by 75g glucose and 300 mL water
Other Names:
Volunteers ingested 300 mL of water containing no chlorogenic acids followed 30 min later by by 75g glucose and 300 mL water
Other Names:
|
|
Experimental: Sequence B
The meal study was performed with dark roast coffee (DAR), light roast coffe (LIR), or water (CTR) in a random sequence.
Sequance B was DAR-CTR-LIR
|
Volunteers ingested 300 mL of coffee with a dark roast containing low levels of chlorogenic acids followed 30 min later by by 75g glucose and 300 mL water
Other Names:
Volunteers ingested 300 mL of coffee with a light roast containing high levels of chlorogenic acids followed 30 min later by by 75g glucose and 300 mL water
Other Names:
Volunteers ingested 300 mL of water containing no chlorogenic acids followed 30 min later by by 75g glucose and 300 mL water
Other Names:
|
|
Experimental: Sequance C
The meal study was performed with dark roast coffee (DAR), light roast coffe (LIR), or water (CTR) in a random sequence.
Sequance C was LIR-DAR-CTR
|
Volunteers ingested 300 mL of coffee with a dark roast containing low levels of chlorogenic acids followed 30 min later by by 75g glucose and 300 mL water
Other Names:
Volunteers ingested 300 mL of coffee with a light roast containing high levels of chlorogenic acids followed 30 min later by by 75g glucose and 300 mL water
Other Names:
Volunteers ingested 300 mL of water containing no chlorogenic acids followed 30 min later by by 75g glucose and 300 mL water
Other Names:
|
|
Experimental: Sequence D
The meal study was performed with dark roast coffee (DAR), light roast coffe (LIR), or water (CTR) in a random sequence.
Sequance D was LIR-CTR-DAR
|
Volunteers ingested 300 mL of coffee with a dark roast containing low levels of chlorogenic acids followed 30 min later by by 75g glucose and 300 mL water
Other Names:
Volunteers ingested 300 mL of coffee with a light roast containing high levels of chlorogenic acids followed 30 min later by by 75g glucose and 300 mL water
Other Names:
Volunteers ingested 300 mL of water containing no chlorogenic acids followed 30 min later by by 75g glucose and 300 mL water
Other Names:
|
|
Experimental: Sequence E
The meal study was performed with dark roast coffee (DAR), light roast coffe (LIR), or water (CTR) in a random sequence.
Sequance E was CTR-DAR-LIR
|
Volunteers ingested 300 mL of coffee with a dark roast containing low levels of chlorogenic acids followed 30 min later by by 75g glucose and 300 mL water
Other Names:
Volunteers ingested 300 mL of coffee with a light roast containing high levels of chlorogenic acids followed 30 min later by by 75g glucose and 300 mL water
Other Names:
Volunteers ingested 300 mL of water containing no chlorogenic acids followed 30 min later by by 75g glucose and 300 mL water
Other Names:
|
|
Experimental: Sequence F
The meal study was performed with dark roast coffee (DAR), light roast coffe (LIR), or water (CTR) in a random sequence.
Sequance F was CTR-LIR-DAR
|
Volunteers ingested 300 mL of coffee with a dark roast containing low levels of chlorogenic acids followed 30 min later by by 75g glucose and 300 mL water
Other Names:
Volunteers ingested 300 mL of coffee with a light roast containing high levels of chlorogenic acids followed 30 min later by by 75g glucose and 300 mL water
Other Names:
Volunteers ingested 300 mL of water containing no chlorogenic acids followed 30 min later by by 75g glucose and 300 mL water
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Plasma glucose Area Under the Curve (Glucose AUC)
Time Frame: 0-120 min
|
The area under the plasma glucose concentration curve was calculated from 0-120min after 75g glucose was ingested.
|
0-120 min
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Plasma glucose concentrations
Time Frame: 30, 60 and120 min
|
changes in the glucose concentration determined by a mixed model analysis and subsequently at each time point with time 0 as a co-variate.
|
30, 60 and120 min
|
|
Serum Insulin Area Under the Curve
Time Frame: 0-120 min
|
Area under the curve (AUC) for serum insulin
|
0-120 min
|
|
Serum insulin concentrations
Time Frame: 30, 60 and120 min
|
changes in the insulin concentration determined by a mixed model analysis and subsequently at each time point with time 0 as a co-variate.
|
30, 60 and120 min
|
|
ISI(0-120)
Time Frame: 0-120min
|
Matsuda's Insulin sensitivity index
|
0-120min
|
|
Metabolic profile in plasma
Time Frame: 0-24 hours
|
Metabolic profile of plasma measured in all samples collected before the meal and postprandially from 0-120 min as well as in samples collected up to 24 hrs later.
|
0-24 hours
|
|
Metabolic profile in urine
Time Frame: 0-24 hours
|
Metabolic profile of urine samples measured in all samples collected before the meal and postprandially from 0-120 min 120-240min as well as in samples collected up to 24 hrs later.
|
0-24 hours
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- M217
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