Coffee Roasting and Glucose Tolerance

Study Overview
=================
Brief Summary
-----------------
Chlorogenic acid (CGA) in coffee may lower the postprandial glucose response. CGA is destroyed by dark roasting. In a controlled crossover trial, 11 healthy fasted volunteers consumed 300 mL of either light (LIR) or dark (DAR) roasted coffee, or water, followed 30 min later by a 75-g oral glucose tolerance test (OGTT). Plasma glukose and insulin, appetite, and plasma and urine metabolic profiles will be analysed. The primary aim is to investigate whether roasting affects the postprandial glucose area under the curve (AUC).

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.

Official Title
-----------------
Acute Effects of Light and Dark Roasted Coffee on Glucose Tolerance: A Randomized, Controlled Crossover Trial in Healthy Volunteers

Conditions
-----------------
Oral Glucose Tolerance

Intervention / Treatment
-----------------
* Other: DAR
* Other: LIR
* Other: CTR


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence A<br>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 | Other: DAR<br>* 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<br>* Other names: 300 mL of coffee with a dark roast + OGTT;Other: LIR<br>* 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<br>* Other names: 300 mL of coffee with a light roast + OGTT;Other: CTR<br>* Volunteers ingested 300 mL of water containing no chlorogenic acids followed 30 min later by by 75g glucose and 300 mL water<br>* Other names: 300 mL of water + OGTT;|
| Experimental: Sequence B<br>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 | Other: DAR<br>* 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<br>* Other names: 300 mL of coffee with a dark roast + OGTT;Other: LIR<br>* 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<br>* Other names: 300 mL of coffee with a light roast + OGTT;Other: CTR<br>* Volunteers ingested 300 mL of water containing no chlorogenic acids followed 30 min later by by 75g glucose and 300 mL water<br>* Other names: 300 mL of water + OGTT;|
| Experimental: Sequance C<br>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 | Other: DAR<br>* 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<br>* Other names: 300 mL of coffee with a dark roast + OGTT;Other: LIR<br>* 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<br>* Other names: 300 mL of coffee with a light roast + OGTT;Other: CTR<br>* Volunteers ingested 300 mL of water containing no chlorogenic acids followed 30 min later by by 75g glucose and 300 mL water<br>* Other names: 300 mL of water + OGTT;|
| Experimental: Sequence D<br>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 | Other: DAR<br>* 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<br>* Other names: 300 mL of coffee with a dark roast + OGTT;Other: LIR<br>* 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<br>* Other names: 300 mL of coffee with a light roast + OGTT;Other: CTR<br>* Volunteers ingested 300 mL of water containing no chlorogenic acids followed 30 min later by by 75g glucose and 300 mL water<br>* Other names: 300 mL of water + OGTT;|
| Experimental: Sequence E<br>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 | Other: DAR<br>* 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<br>* Other names: 300 mL of coffee with a dark roast + OGTT;Other: LIR<br>* 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<br>* Other names: 300 mL of coffee with a light roast + OGTT;Other: CTR<br>* Volunteers ingested 300 mL of water containing no chlorogenic acids followed 30 min later by by 75g glucose and 300 mL water<br>* Other names: 300 mL of water + OGTT;|
| Experimental: Sequence F<br>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 | Other: DAR<br>* 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<br>* Other names: 300 mL of coffee with a dark roast + OGTT;Other: LIR<br>* 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<br>* Other names: 300 mL of coffee with a light roast + OGTT;Other: CTR<br>* Volunteers ingested 300 mL of water containing no chlorogenic acids followed 30 min later by by 75g glucose and 300 mL water<br>* Other names: 300 mL of water + OGTT;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma glucose Area Under the Curve (Glucose AUC) | 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 | 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 | Area under the curve (AUC) for serum insulin | 0-120 min | 
| Serum insulin concentrations | 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) | Matsuda's Insulin sensitivity index | 0-120min | 
| Metabolic profile in plasma | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coffee, Chlorogenic acid, Insulin, Appetite, Metabolomics