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Coffee Roasting and Glucose Tolerance

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ClinicalTrials.gov Identifier: NCT02417519
Recruitment Status : Completed
First Posted : April 15, 2015
Last Update Posted : December 12, 2017
Sponsor:
Information provided by (Responsible Party):
Professor Lars Ove Dragsted, University of Copenhagen

Tracking Information
First Submitted Date  ICMJE April 11, 2015
First Posted Date  ICMJE April 15, 2015
Last Update Posted Date December 12, 2017
Study Start Date  ICMJE April 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 11, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02417519 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2015)
  • 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.
  • Serum Insulin Area Under the Curve [ Time Frame: 0-120 min ]
    Area under the curve (AUC) for serum insulin
  • 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.
  • ISI(0-120) [ Time Frame: 0-120min ]
    Matsuda's Insulin sensitivity index
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Coffee Roasting and Glucose Tolerance
Official Title  ICMJE Acute Effects of Light and Dark Roasted Coffee on Glucose Tolerance: A Randomized, Controlled Crossover Trial in Healthy Volunteers
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Oral Glucose Tolerance
Intervention  ICMJE
  • 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
    Other Name: 300 mL of coffee with a dark roast + OGTT
  • Other: 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
    Other Name: 300 mL of coffee with a light roast + OGTT
  • Other: CTR
    Volunteers ingested 300 mL of water containing no chlorogenic acids followed 30 min later by by 75g glucose and 300 mL water
    Other Name: 300 mL of water + OGTT
Study Arms  ICMJE
  • 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
    Interventions:
    • Other: DAR
    • Other: LIR
    • Other: CTR
  • 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
    Interventions:
    • Other: DAR
    • Other: LIR
    • Other: CTR
  • 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
    Interventions:
    • Other: DAR
    • Other: LIR
    • Other: CTR
  • 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
    Interventions:
    • Other: DAR
    • Other: LIR
    • Other: CTR
  • 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
    Interventions:
    • Other: DAR
    • Other: LIR
    • Other: CTR
  • 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
    Interventions:
    • Other: DAR
    • Other: LIR
    • Other: CTR
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 11, 2015)
11
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2015
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02417519
Other Study ID Numbers  ICMJE M217
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Professor Lars Ove Dragsted, University of Copenhagen
Study Sponsor  ICMJE University of Copenhagen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lars O Dragsted, PhD University of Copenhagen
PRS Account University of Copenhagen
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP