HealthyNCT02099929
Effects of Coffee Consumption on Glucose Metabolism
A study testing Coffee with Sugar, Coffee without Sugar and Decaffeinated Coffee without Sugar in people with Healthy, run by University of Brasilia at 1 site in Brazil.
Trial summary
Epidemiological studies have shown an inverse association between coffee consumption and risk of type 2 diabetes mellitus (T2DM). However the experimental studies that analysed the mechanisms are limited. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Coffee with Sugar, Coffee without Sugar and Decaffeinated Coffee without Sugar
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2012to Dec 2013
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male healthy young adults (18 - 50 years old);
- Body mass index (BMI) between 18.5 - 28.0 kg/m²;
- No weight changes (≥ 5 kg) in the last 3 months;
- Not take any pills/drugs that alter metabolism, appetite and sleep;
- Not have sleep disorders;
- Not have donated blood in the last 3 months;
- Regular breakfast consumption (≥100 kcal ingested up to 2 hours after waking ≥4x/week);
- Being a habitual coffee consumer (≥100mL ≥5x/week).
Who cannot join
- Diagnosis of anemia, metabolic and heart diseases;
- Previous sudden fainting and convulsions;
- Any drugs and tobacco consumption;
- Consumption of more than 500mg of caffeine / day (5 cups of coffee, tea and cola soft drinks).
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Laboratório de Bioquímica da Nutrição, Núcleo de Nutrição e Medicina Tropical, Universidade de Brasília
Brasília, Federal District, 70910-900
About this study
Official title: Coffee and Glucose Metabolism: Clinical, Crossover and Randomized Glucose Disposal Assay Using Stable Isotopes
Epidemiological studies have shown an inverse association between coffee consumption and risk of type 2 diabetes mellitus (T2DM). However the experimental studies that analysed the mechanisms are limited.
This project aims to assess the effects of coffee consumption on glucose metabolism, using stable isotope tracer (13C-glucose) to explain the possible metabolic mechanisms involved on the reduced risk for T2DM.
Read the detailed description
This is a crossover randomized clinical trial that has been studying 14 male healthy young adults, who were enrolled five treatments: coffee with sugar, coffee without sugar, decaffeinated coffee without sugar and two controls (water with and without sugar).
The stable isotope minimal model protocol with oral glucose administration (Oral Dose Intravenous Label Experiment - ODILE) was performed. The use of ODILE methodology permits separation of the glucose absorbed and removed from the circulation increasing the accuracy and the effectiveness of glucose uptake and insulin sensitivity (Bluck et al., 2006).
- Conditions
- Healthy
- Being tested
- Coffee with Sugar, Coffee without Sugar, Decaffeinated Coffee without Sugar, Water with Sugar, Water without Sugar
- Keywords
- Coffee, Glucose, Insulin, Diabetes, Type 2 Diabetes Mellitus
- Medical subject headings
- Insulin Resistance, Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coffee with SugarOther
300mL of Coffee with 30g of Sugar
Coffee without SugarOther
300mL of Coffee without Sugar
Decaffeinated Coffee without SugarOther
300mL of Decaffeinated Coffee without Sugar
Water with SugarOther
300mL of Water with 30g of Sugar
Water without SugarOther
300mL of Water without Sugar
| Study group | Role | What they receive |
|---|---|---|
| Coffee with Sugar | Experimental | 300mL of Coffee with 30g of Sugar Receives: Other: Coffee with Sugar |
| Coffee without Sugar | Experimental | 300mL of Coffee without Sugar Receives: Other: Coffee without Sugar |
| Decaffeinated Coffee without Sugar | Experimental | 300mL of Decaffeinated Coffee without Sugar Receives: Other: Decaffeinated Coffee without Sugar |
| Water with Sugar | Sham comparator | 300mL of Water with 30g of Sugar Receives: Other: Water with Sugar |
| Water without Sugar | Sham comparator | 300mL of Water without Sugar Receives: Other: Water without Sugar |
What is being measured
The primary outcome is the main question the study is designed to answer.
ODILE minimal model analysis
The stable isotope minimal model protocol with oral glucose administration (Oral Dose Intravenous Label Experiment - ODILE)
Measured: -10, 0, 30, 60/0, 15, 30, 45, 47, 49, 51, 53, 55, 57, 59, 61, 65, 70, 75, 80, 85, 90, 100, 115, 135, 165, 195, 225 minutes.
Secondary outcomes (1)
Glucose metabolism
Glucose and Insulin levels, and Insulin sensitivity indices.
Measured: -10, 0, 30, 60/0, 15, 30, 45, 47, 49, 51, 53, 55, 57, 59, 61, 65, 70, 75, 80, 85, 90, 100, 115, 135, 165, 195, 225 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2014 (estimated)
- Study startJun 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Brasilia
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, MRC Human Nutrition Research
- Responsible party
- Principal investigator, Caio Eduardo Gonçalves Reis, University of Brasilia
- Investigators
- Leslie JC Bluck, PhD, Study chair, MRC Human Nutrition ResearchTeresa HM da Costa, PhD, Study director, University of BrasiliaCaio EG Reis, MSc, Principal investigator, University of Brasilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02099929
- Sponsor's protocol ID
- GliCafé
- Status last verified
- Mar 2014
- First submitted
- 26 Mar 2014
- Last updated
- 31 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bluck LJ, Clapperton AT, Coward WA. A stable isotope minimal model protocol with oral glucose administration. Rapid Commun Mass Spectrom. 2006;20(3):493-8. doi: 10.1002/rcm.2326.
PubMed 16402351
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coffee and Glucose Metabolism: Clinical, Crossover and Randomized Glucose Disposal Assay Using Stable Isotopes
- ClinicalTrials.gov ID
- NCT02099929
- Acronym / sponsor ID
- GliCafé
- Conditions
- Healthy
- Keywords
- Coffee, Glucose, Insulin, Diabetes, Type 2 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of BrasiliaUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, MRC Human Nutrition Research
- Study start
- Jun 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 31 Mar 2014 (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.
Epidemiological studies have shown an inverse association between coffee consumption and risk of type 2 diabetes mellitus (T2DM). However the experimental studies that analysed the mechanisms are limited.
This project aims to assess the effects of coffee consumption on glucose metabolism, using stable isotope tracer (13C-glucose) to explain the possible metabolic mechanisms involved on the reduced risk for T2DM.
Detailed description
This is a crossover randomized clinical trial that has been studying 14 male healthy young adults, who were enrolled five treatments: coffee with sugar, coffee without sugar, decaffeinated coffee without sugar and two controls (water with and without sugar).
The stable isotope minimal model protocol with oral glucose administration (Oral Dose Intravenous Label Experiment - ODILE) was performed. The use of ODILE methodology permits separation of the glucose absorbed and removed from the circulation increasing the accuracy and the effectiveness of glucose uptake and insulin sensitivity (Bluck et al., 2006).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Coffee with Sugar | Experimental | Other: Coffee with Sugar300mL of Coffee with 30g of Sugar |
| Coffee without Sugar | Experimental | Other: Coffee without Sugar300mL of Coffee without Sugar |
| Decaffeinated Coffee without Sugar | Experimental | Other: Decaffeinated Coffee without Sugar300mL of Decaffeinated Coffee without Sugar |
| Water with Sugar | Sham comparator | Other: Water with Sugar300mL of Water with 30g of Sugar |
| Water without Sugar | Sham comparator | Other: Water without Sugar300mL of Water without Sugar |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male healthy young adults (18 - 50 years old);
- Body mass index (BMI) between 18.5 - 28.0 kg/m²;
- No weight changes (≥ 5 kg) in the last 3 months;
- Not take any pills/drugs that alter metabolism, appetite and sleep;
- Not have sleep disorders;
Key exclusion criteria (4 listed)
- Diagnosis of anemia, metabolic and heart diseases;
- Previous sudden fainting and convulsions;
- Any drugs and tobacco consumption;
- Consumption of more than 500mg of caffeine / day (5 cups of coffee, tea and cola soft drinks).
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 |
|---|---|---|
| Coffee with Sugar300mL of Coffee with 30g of Sugar | Other | Coffee with Sugar |
| Coffee without Sugar300mL of Coffee without Sugar | Other | Coffee without Sugar |
| Decaffeinated Coffee without Sugar300mL of Decaffeinated Coffee without Sugar | Other | Decaffeinated Coffee without Sugar |
| Water with Sugar300mL of Water with 30g of Sugar | Other | Water with Sugar |
| Water without Sugar300mL of Water without Sugar | Other | Water without Sugar |
Primary outcome
ODILE minimal model analysis
Time frame: -10, 0, 30, 60/0, 15, 30, 45, 47, 49, 51, 53, 55, 57, 59, 61, 65, 70, 75, 80, 85, 90, 100, 115, 135, 165, 195, 225 minutes.
The stable isotope minimal model protocol with oral glucose administration (Oral Dose Intravenous Label Experiment - ODILE)
1 secondary outcome
Glucose metabolism
Time frame: -10, 0, 30, 60/0, 15, 30, 45, 47, 49, 51, 53, 55, 57, 59, 61, 65, 70, 75, 80, 85, 90, 100, 115, 135, 165, 195, 225 minutes.
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 31 Mar 2014.
- Background: PubMed 16402351Bluck LJ, Clapperton AT, Coward WA. A stable isotope minimal model protocol with oral glucose administration. Rapid Commun Mass Spectrom. 2006;20(3):493-8. doi: 10.1002/rcm.2326.
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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.
Leslie JC Bluck, PhD study chair
MRC Human Nutrition Research
Teresa HM da Costa, PhD study director
University of Brasilia
Caio EG Reis, MSc principal investigator
University of Brasilia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coffee with Sugar, Coffee without Sugar and Decaffeinated Coffee without Sugar in people with Healthy, run by University of Brasilia at 1 site in Brazil.
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 8 inclusion and 4 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 31 Mar 2014. 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 Brazil. 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. Some participants in this study may receive a placebo. 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?
ODILE minimal model analysis (time frame: -10, 0, 30, 60/0, 15, 30, 45, 47, 49, 51, 53, 55, 57, 59, 61, 65, 70, 75, 80, 85, 90, 100, 115, 135, 165, 195, 225 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02099929, which also lists 1 linked publication.
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 31 Mar 2014.