Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02417519
Other study ID # M217
Secondary ID
Status Completed
Phase N/A
First received April 11, 2015
Last updated December 11, 2017
Start date April 2014
Est. completion date November 2015

Study information

Verified date December 2017
Source University of Copenhagen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 11
Est. completion date November 2015
Est. primary completion date September 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
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
LIR
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
Volunteers ingested 300 mL of water containing no chlorogenic acids followed 30 min later by by 75g glucose and 300 mL water

Locations

Country Name City State
Denmark Department of Nutrition, Exercise and Sports, University of Copenhagen Frederiksberg

Sponsors (1)

Lead Sponsor Collaborator
University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary Serum Insulin Area Under the Curve Area under the curve (AUC) for serum insulin 0-120 min
Secondary 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
Secondary ISI(0-120) Matsuda's Insulin sensitivity index 0-120min
Secondary 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
Secondary 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
See also
  Status Clinical Trial Phase
Recruiting NCT05441982 - Saccharin and Acesulfame Potassium Consumption and Glucose Homeostasis in Older Adults With Prediabetes N/A
Completed NCT02999321 - The Effects of Aspartame on Appetite, Body Composition and Oral Glucose Tolerance N/A
Recruiting NCT05337098 - Non-Nutritive Sweetener Consumption and Glucose Homeostasis in Older Adults With Prediabetes N/A