Overview

This trial is active, not recruiting.

Condition oral glucose tolerance
Treatments dar, lir, ctr
Sponsor University of Copenhagen
Start date April 2014
End date September 2014
Trial size 11 participants
Trial identifier NCT02417519, M217

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking double blind (investigator, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
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
dar 300 mL of coffee with a dark roast + OGTT
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
lir 300 mL of coffee with a light roast + OGTT
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
ctr 300 mL of water + OGTT
Volunteers ingested 300 mL of water containing no chlorogenic acids followed 30 min later by by 75g glucose and 300 mL water
(Experimental)
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
dar 300 mL of coffee with a dark roast + OGTT
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
lir 300 mL of coffee with a light roast + OGTT
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
ctr 300 mL of water + OGTT
Volunteers ingested 300 mL of water containing no chlorogenic acids followed 30 min later by by 75g glucose and 300 mL water
(Experimental)
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
dar 300 mL of coffee with a dark roast + OGTT
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
lir 300 mL of coffee with a light roast + OGTT
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
ctr 300 mL of water + OGTT
Volunteers ingested 300 mL of water containing no chlorogenic acids followed 30 min later by by 75g glucose and 300 mL water
(Experimental)
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
dar 300 mL of coffee with a dark roast + OGTT
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
lir 300 mL of coffee with a light roast + OGTT
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
ctr 300 mL of water + OGTT
Volunteers ingested 300 mL of water containing no chlorogenic acids followed 30 min later by by 75g glucose and 300 mL water
(Experimental)
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
dar 300 mL of coffee with a dark roast + OGTT
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
lir 300 mL of coffee with a light roast + OGTT
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
ctr 300 mL of water + OGTT
Volunteers ingested 300 mL of water containing no chlorogenic acids followed 30 min later by by 75g glucose and 300 mL water
(Experimental)
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
dar 300 mL of coffee with a dark roast + OGTT
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
lir 300 mL of coffee with a light roast + OGTT
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
ctr 300 mL of water + OGTT
Volunteers ingested 300 mL of water containing no chlorogenic acids followed 30 min later by by 75g glucose and 300 mL water

Primary Outcomes

Measure
Plasma glucose Area Under the Curve (Glucose AUC)
time frame: 0-120 min

Secondary Outcomes

Measure
Plasma glucose concentrations
time frame: 30, 60 and120 min
Serum Insulin Area Under the Curve
time frame: 0-120 min
Serum insulin concentrations
time frame: 30, 60 and120 min
ISI(0-120)
time frame: 0-120min
Metabolic profile in plasma
time frame: 0-24 hours
Metabolic profile in urine
time frame: 0-24 hours

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title Acute Effects of Light and Dark Roasted Coffee on Glucose Tolerance: A Randomized, Controlled Crossover Trial in Healthy Volunteers
Principal investigator Lars O Dragsted, PhD
Description Epidemiological 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 normalise 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 differentially affect glucose regulation. 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). 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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by University of Copenhagen.