HealthNCT01174576
Acute Effects of Coffee on Appetite and Inflammation Markers, Glucose Metabolism and Energy Intake
A study testing caffeinated and decaffeinated coffee in people with Health, run by Harokopio University at 1 site in Greece.
Trial summary
The purpose of the study is to investigate whether caffeinated and decaffeinated coffee consumption has acute effects on subjective appetite feelings, energy intake and biochemical markers related to appetite, inflammation and glucose metabolism compared to water consumption. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Health
- What is being tested?
- caffeinated and decaffeinated coffee
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteGreece
- Study dates
- Feb 2009to May 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy
- non-obese
Who cannot join
- smokers
- restrained eaters (as this was evaluated using the Dutch Eating Behaviour Questionnaire and a total score > 2.5)
- those who reported slimming or any other dietary regime
- abstainers from caffeine sources
- athletes during competition period
- participants with a known diagnosis of either hypertension, diabetes, impaired glucose tolerance or a fasting blood glucose concentration above 125 mg/dl
- subjects on medication for hypertension or on medication known to alter glucose metabolism
- subjects who were on medication that may have an impact on appetite and sensory functioning or who reported a metabolic or endocrine disease, gastrointestinal disorders, or a history of medical or surgical events that may have affected the study outcomes
Trial locations and contacts
1 site in 1 country.
Greece1 site
Metabolic Unit of the Department of Nutrition and Dietetics, Harokopio University
Athens, 17671
About this study
Official title: Acute Effects of Caffeinated and Decaffeinated Coffee Consumption on Energy Intake, Appetite, Inflammation and Glucose Metabolism
The purpose of the study is to investigate whether caffeinated and decaffeinated coffee consumption has acute effects on subjective appetite feelings, energy intake and biochemical markers related to appetite, inflammation and glucose metabolism compared to water consumption.
Read the detailed description
Coffee is a pharmacologically active, widely consumed beverage. Scientific interest in relation to coffee consumption has been revisited the last decade in the light of new, mainly epidemiological, evidence indicating its potential health benefits. In specific, both cross-sectional and prospective studies indicate that coffee consumption is associated with a lower risk for type 2 diabetes. Furthermore, an inverse association has been found between coffee consumption and markers of inflammation and endothelial dysfunction in healthy and/or diabetic participants, although the opposite effect has also been reported, mainly in relation to inflammation markers. In relation to body weight, epidemiological data suggest that increment in caffeine consumption is associated with lower mean weight gain and energy intake during a 12-y period.
However, information from clinical studies is scarce. Acute caffeine and/or coffee consumption have been associated with impaired glucose metabolism and insulin resistance. In relation to inflammation, animal studies have indicated a beneficial or no effect of coffee consumption, whereas a clinical study in humans found an increase in adiponectin and a decrease in interleukin-18 (IL-18) blood concentrations after a monthly intervention including daily consumption of 8 cups of coffee. As far as energy balance is concerned, there is an early experiment demonstrating that the ingestion of 300 mg of caffeine prior to food intake, compared to the non-caffeine intake, significantly reduced energy intake by 21.7% in men, but not in women. A more recent study has found that the combination of caffeine and red pepper is positively associated with energy expenditure and negatively with energy intake, whereas, it has also been reported a positive association between habitual caffeine intake and body weight loss achieved through a very-low-calorie diet.
Taking into consideration the limited clinical evidence regarding the acute effect of coffee consumption on appetite-related markers, subsequent energy intake and inflammatory markers, we undertook a clinical study of crossover design to investigate the short-term changes on energy intake, subjective appetite ratings, appetite hormones, inflammation markers and glucose metabolism after caffeinated and decaffeinated coffee consumption.
- Conditions
- Health
- Being tested
- caffeinated and decaffeinated coffee
- Keywords
- coffee, appetite, energy intake, inflammation, cortisol, glucose, randomized controlled trial
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
caffeinated and decaffeinated coffeeOther
3 treatments on separate days, i.e. a standard breakfast with oral ingestion of 200 ml of either caffeinated coffee (3mg caffeine/kg body weight), decaffeinated coffee or water
| Study group | Role | What they receive |
|---|---|---|
| caffeinated coffee | Experimental | 200 mL caffeinated coffee with 3 mg caffeine per kg body weight Receives: Other: caffeinated and decaffeinated coffee |
| decaffeinated coffee | Experimental | 200 mL decaffeinated coffee, same amount as caffeinated coffee Receives: Other: caffeinated and decaffeinated coffee |
| Water | Experimental | 200 mL, control intervention Receives: Other: caffeinated and decaffeinated coffee |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ghrelin Total Area Under the Curve
Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.
Measured: 15 min before ingestion to 3 hr post ingestion
Peptide Tyrosine Tyrosine (PYY) Total Area Under the Curve
Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.
Measured: 15 min before ingestion to 3 hr post ingestion
Glucagon-like Peptide-1 (GLP-1) Total Area Under the Curve
Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.
Measured: 15 min before ingestion to 3 hr post ingestion
Adiponectin Total Area Under the Curve
Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.
Measured: 15 min before ingestion to 3 h post ingestion
Inteleukin-6 Total Area Under the Curve
Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.
Measured: 15 min before ingestion to 3 hr post ingestion
Interleukin-18 Total Area Under the Curve
Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.
Measured: 15 min before ingestion to 3 hr post ingestion
Glucose Total Area Under the Curve
Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.
Measured: 15 min before ingestion to 3 hr post ingestion
Insulin Total Area Under the Curve
Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.
Measured: 15 min before ingestion to 3 hr post ingestion
Cortisol Total Area Under the Curve
Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.
Measured: 15 min before ingestion to 3 hr post ingestion
Energy ad Libitum Meal
The energy of first meal 3 hr after ingestion
Measured: 3 hr post ingestion
Total Energy Intake
the energy consumed at breakfast, ad libitum meal and rest of the experimental day
Measured: 1 d
Secondary outcomes (1)
Serum Antioxidant Capacity Total Area Under the Curve
Serum samples, collected 15 min before ingestion, immediately after ingestion, 15 min, 30 min, 60 min, 90 min, 120 min and 150 min after ingestion were analyzed for the ex vivo serum resistance to oxidative stress, that was induced by copper sulfate (CuSO4). The analysis of all collected samples was performed by the measurement of conjugated diene formation, which was monitored for every sample of all time points every 2 min for a 3.5 h period at 234 nm in a microplate spectrophotometer.
Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150 min postconsumption.
Measured: 15 min before ingestion to 21/2 hr post ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2010 (estimated)
- Study startFeb 2009
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harokopio University
- Sponsor type
- University, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center
- Responsible party
- Principal investigator, M. Yannakoulia, Harokopio University
- Investigators
- Mary Yannakoulia, PhD, Study director, Harokopio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01174576
- Sponsor's protocol ID
- CofSt
- Status last verified
- Jul 2013
- First submitted
- 26 Jul 2010
- Last updated
- 30 Sep 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Gavrieli A, Yannakoulia M, Fragopoulou E, Margaritopoulos D, Chamberland JP, Kaisari P, Kavouras SA, Mantzoros CS. Caffeinated coffee does not acutely affect energy intake, appetite, or inflammation but prevents serum cortisol concentrations from falling in healthy men. J Nutr. 2011 Apr 1;141(4):703-7. doi: 10.3945/jn.110.137323. Epub 2011 Feb 23.
PubMed 21346100
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Caffeinated and Decaffeinated Coffee Consumption on Energy Intake, Appetite, Inflammation and Glucose Metabolism
- ClinicalTrials.gov ID
- NCT01174576
- Acronym / sponsor ID
- CofSt
- Conditions
- Health
- Keywords
- coffee, appetite, energy intake, inflammation, cortisol, glucose, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Harokopio UniversityUniversity, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center
- Study start
- Feb 2009
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 3 Aug 2010 (estimated)
- Results
- Posted 30 Sep 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to investigate whether caffeinated and decaffeinated coffee consumption has acute effects on subjective appetite feelings, energy intake and biochemical markers related to appetite, inflammation and glucose metabolism compared to water consumption.
Detailed description
Coffee is a pharmacologically active, widely consumed beverage. Scientific interest in relation to coffee consumption has been revisited the last decade in the light of new, mainly epidemiological, evidence indicating its potential health benefits. In specific, both cross-sectional and prospective studies indicate that coffee consumption is associated with a lower risk for type 2 diabetes. Furthermore, an inverse association has been found between coffee consumption and markers of inflammation and endothelial dysfunction in healthy and/or diabetic participants, although the opposite effect has also been reported, mainly in relation to inflammation markers. In relation to body weight, epidemiological data suggest that increment in caffeine consumption is associated with lower mean weight gain and energy intake during a 12-y period.
However, information from clinical studies is scarce. Acute caffeine and/or coffee consumption have been associated with impaired glucose metabolism and insulin resistance. In relation to inflammation, animal studies have indicated a beneficial or no effect of coffee consumption, whereas a clinical study in humans found an increase in adiponectin and a decrease in interleukin-18 (IL-18) blood concentrations after a monthly intervention including daily consumption of 8 cups of coffee. As far as energy balance is concerned, there is an early experiment demonstrating that the ingestion of 300 mg of caffeine prior to food intake, compared to the non-caffeine intake, significantly reduced energy intake by 21.7% in men, but not in women. A more recent study has found that the combination of caffeine and red pepper is positively associated with energy expenditure and negatively with energy intake, whereas, it has also been reported a positive association between habitual caffeine intake and body weight loss achieved through a very-low-calorie diet.
Taking into consideration the limited clinical evidence regarding the acute effect of coffee consumption on appetite-related markers, subsequent energy intake and inflammatory markers, we undertook a clinical study of crossover design to investigate the short-term changes on energy intake, subjective appetite ratings, appetite hormones, inflammation markers and glucose metabolism after caffeinated and decaffeinated coffee consumption.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| caffeinated coffee | Experimental | Other: caffeinated and decaffeinated coffee200 mL caffeinated coffee with 3 mg caffeine per kg body weight |
| decaffeinated coffee | Experimental | Other: caffeinated and decaffeinated coffee200 mL decaffeinated coffee, same amount as caffeinated coffee |
| Water | Experimental | Other: caffeinated and decaffeinated coffee200 mL, control intervention |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- healthy
- non-obese
Key exclusion criteria (8 listed)
- smokers
- restrained eaters (as this was evaluated using the Dutch Eating Behaviour Questionnaire and a total score > 2.5)
- those who reported slimming or any other dietary regime
- abstainers from caffeine sources
- athletes during competition period
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 |
|---|---|---|
| caffeinated and decaffeinated coffee3 treatments on separate days, i.e. a standard breakfast with oral ingestion of 200 ml of either caffeinated coffee (3mg caffeine/kg body weight), decaffeinated coffee or water | Other | Water, caffeinated coffee, decaffeinated coffee |
Primary outcome
Ghrelin Total Area Under the Curve
Time frame: 15 min before ingestion to 3 hr post ingestion
Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.
Peptide Tyrosine Tyrosine (PYY) Total Area Under the Curve
Time frame: 15 min before ingestion to 3 hr post ingestion
Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.
Glucagon-like Peptide-1 (GLP-1) Total Area Under the Curve
Time frame: 15 min before ingestion to 3 hr post ingestion
Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.
Adiponectin Total Area Under the Curve
Time frame: 15 min before ingestion to 3 h post ingestion
Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.
Inteleukin-6 Total Area Under the Curve
Time frame: 15 min before ingestion to 3 hr post ingestion
Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.
Interleukin-18 Total Area Under the Curve
Time frame: 15 min before ingestion to 3 hr post ingestion
Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.
Glucose Total Area Under the Curve
Time frame: 15 min before ingestion to 3 hr post ingestion
Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.
Insulin Total Area Under the Curve
Time frame: 15 min before ingestion to 3 hr post ingestion
Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.
Cortisol Total Area Under the Curve
Time frame: 15 min before ingestion to 3 hr post ingestion
Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.
Energy ad Libitum Meal
Time frame: 3 hr post ingestion
The energy of first meal 3 hr after ingestion
Total Energy Intake
Time frame: 1 d
the energy consumed at breakfast, ad libitum meal and rest of the experimental day
1 secondary outcome
Serum Antioxidant Capacity Total Area Under the Curve
Time frame: 15 min before ingestion to 21/2 hr post ingestion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21346100Gavrieli A, Yannakoulia M, Fragopoulou E, Margaritopoulos D, Chamberland JP, Kaisari P, Kavouras SA, Mantzoros CS. Caffeinated coffee does not acutely affect energy intake, appetite, or inflammation but prevents serum cortisol concentrations from falling in healthy men. J Nutr. 2011 Apr 1;141(4):703-7. doi: 10.3945/jn.110.137323. Epub 2011 Feb 23.
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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.
Mary Yannakoulia, PhD study director
Harokopio University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing caffeinated and decaffeinated coffee in people with Health, run by Harokopio University at 1 site in Greece.
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 2 inclusion and 8 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 30 Sep 2013. 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 Greece. 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?
Yes. Results are posted in the registry (first posted 30 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Ghrelin Total Area Under the Curve (time frame: 15 min before ingestion to 3 hr post ingestion). The study lists 11 primary outcomes in all. 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 NCT01174576, 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 30 Sep 2013.