Oral Glucose ToleranceNCT02417519
Coffee Roasting and Glucose Tolerance
A study testing DAR, LIR and CTR in people with Oral Glucose Tolerance, run by University of Copenhagen at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Glucose Tolerance
- What is being tested?
- DAR, LIR and CTR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2014to Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index (BMI) of 18.0-30.0 kg/m2 and with no known diseases
Who cannot join
- 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,
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Nutrition, Exercise and Sports, University of Copenhagen
Frederiksberg, 1958
About this study
Official title: Acute Effects of Light and Dark Roasted Coffee on Glucose Tolerance: A Randomized, Controlled Crossover Trial in Healthy Volunteers
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).
Read the 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.
- Conditions
- Oral Glucose Tolerance
- Being tested
- DAR, LIR, CTR
- Keywords
- Coffee, Chlorogenic acid, Insulin, Appetite, Metabolomics
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DAROther
Also called 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
LIROther
Also called 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
CTROther
Also called 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: DAR; Other: LIR; Other: 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 Receives: Other: DAR; Other: LIR; Other: 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 Receives: Other: DAR; Other: LIR; Other: 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 Receives: Other: DAR; Other: LIR; Other: 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 Receives: Other: DAR; Other: LIR; Other: 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 Receives: Other: DAR; Other: LIR; Other: CTR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0-120 min
Secondary outcomes (6)
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.
Measured: 30, 60 and120 min
Serum Insulin Area Under the Curve
Area under the curve (AUC) for serum insulin
Measured: 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.
Measured: 30, 60 and120 min
ISI(0-120)
Matsuda's Insulin sensitivity index
Measured: 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.
Measured: 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.
Measured: 0-24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2015 (estimated)
- Study startApr 2014
- Primary completionSep 2014
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Glucose ToleranceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Lars Ove Dragsted, University of Copenhagen
- Investigators
- Lars O Dragsted, PhD, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02417519
- Sponsor's protocol ID
- M217
- Status last verified
- Dec 2017
- First submitted
- 11 Apr 2015
- Last updated
- 12 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Light and Dark Roasted Coffee on Glucose Tolerance: A Randomized, Controlled Crossover Trial in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02417519
- Acronym / sponsor ID
- M217
- Conditions
- Oral Glucose Tolerance
- Keywords
- Coffee, Chlorogenic acid, Insulin, Appetite, Metabolomics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 15 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Sequence A | Experimental | Other: DAR, Other: LIR, Other: CTRThe 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 |
| Sequence B | Experimental | Other: DAR, Other: LIR, Other: CTRThe 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 |
| Sequance C | Experimental | Other: DAR, Other: LIR, Other: CTRThe 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 |
| Sequence D | Experimental | Other: DAR, Other: LIR, Other: CTRThe 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 |
| Sequence E | Experimental | Other: DAR, Other: LIR, Other: CTRThe 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 |
| Sequence F | Experimental | Other: DAR, Other: LIR, Other: CTRThe 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Body mass index (BMI) of 18.0-30.0 kg/m2 and with no known diseases
Key exclusion criteria (9 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DARAlso: 300 mL of coffee with a dark roast + OGTTVolunteers 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 | Sequance C, Sequence A, Sequence B, Sequence D, Sequence E, Sequence F |
| LIRAlso: 300 mL of coffee with a light roast + OGTTVolunteers 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 | Sequance C, Sequence A, Sequence B, Sequence D, Sequence E, Sequence F |
| CTRAlso: 300 mL of water + OGTTVolunteers ingested 300 mL of water containing no chlorogenic acids followed 30 min later by by 75g glucose and 300 mL water | Other | Sequance C, Sequence A, Sequence B, Sequence D, Sequence E, Sequence F |
Primary outcome
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.
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars O Dragsted, PhD principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DAR, LIR and CTR in people with Oral Glucose Tolerance, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma glucose Area Under the Curve (Glucose AUC) (time frame: 0-120 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2017.