NCT02417519

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 15, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

December 12, 2017

Status Verified

December 1, 2017

Enrollment Period

5 months

First QC Date

April 11, 2015

Last Update Submit

December 11, 2017

Conditions

Keywords

CoffeeChlorogenic acidInsulinAppetiteMetabolomics

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Plasma glucose concentrations

    30, 60 and120 min

  • Serum Insulin Area Under the Curve

    0-120 min

  • Serum insulin concentrations

    30, 60 and120 min

  • ISI(0-120)

    0-120min

  • Metabolic profile in plasma

    0-24 hours

  • +1 more secondary outcomes

Study Arms (6)

Sequence A

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

Other: DAROther: LIROther: CTR

Sequence B

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

Other: DAROther: LIROther: CTR

Sequance C

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

Other: DAROther: LIROther: CTR

Sequence D

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

Other: DAROther: LIROther: CTR

Sequence E

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

Other: DAROther: LIROther: CTR

Sequence F

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

Other: DAROther: LIROther: CTR

Interventions

DAROTHER

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

Also known as: 300 mL of coffee with a dark roast + OGTT
Sequance CSequence ASequence BSequence DSequence ESequence F
LIROTHER

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

Also known as: 300 mL of coffee with a light roast + OGTT
Sequance CSequence ASequence BSequence DSequence ESequence F
CTROTHER

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

Also known as: 300 mL of water + OGTT
Sequance CSequence ASequence BSequence DSequence ESequence F

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Body mass index (BMI) of 18.0-30.0 kg/m2 and with no known diseases

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nutrition, Exercise and Sports, University of Copenhagen

Frederiksberg, 1958, Denmark

Location

MeSH Terms

Conditions

Insulin Resistance

Interventions

CoffeeGlucose Tolerance TestWater

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Plant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesBlood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineInvestigative TechniquesHydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Officials

  • Lars O Dragsted, PhD

    University of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 11, 2015

First Posted

April 15, 2015

Study Start

April 1, 2014

Primary Completion

September 1, 2014

Study Completion

November 1, 2015

Last Updated

December 12, 2017

Record last verified: 2017-12

Locations