ObesityNCT01495754
Effects of Different Coffee Amounts on Energy Intake, Appetite, Glucose Metabolism and Inflammatory Markers
A study testing coffee in people with Obesity and Inflammation, run by Harokopio University at 1 site in Greece.
Trial summary
The purpose of the study is to investigate whether different doses of caffeinated 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 in normal weight and overweight/obese… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Inflammation
- What is being tested?
- coffee
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteGreece
- Study dates
- Jan 2011to Jun 2011
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- apparently healthy
- habitual coffee drinkers (>= 1cup of coffee/day)
Who cannot join
- smokers
- restrained eaters (as this was evaluated using the Dutch Eating Behaviour Questionnaire)
- those who reported slimming or any other dietary regime
- athletes
- 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
Show all 10Show fewer
- 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,
- 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: The Effect of Different Amounts of Coffee on Dietary Intake, Appetite-related Feeling, Appetite Hormones, Glucose Metabolism and Inflammatory Markers of Normal Weight and Overweight/Obese Individuals
The purpose of the study is to investigate whether different doses of caffeinated 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 in normal weight and overweight/obese participants.
- Conditions
- Obesity, Inflammation
- Being tested
- coffee
- Keywords
- coffee, overweight/obese, appetite, energy intake, inflammation, glucose metabolism, randomized controlled trial
- Medical subject headings
- Obesity, Inflammation, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coffeeOther
Comparison of different amounts of coffee
| Study group | Role | What they receive |
|---|---|---|
| coffee3 | Experimental | Not described Receives: Other: coffee |
| coffee6 | Experimental | Not described Receives: Other: coffee |
| water | Placebo comparator | Not described Receives: Other: coffee |
What is being measured
The primary outcome is the main question the study is designed to answer.
energy intake ad libitum
Measured: 180 min after breakfast/drink consumption
total energy intake
Measured: One day
appetite feelings
Measured: fasting (-15 min)
appetite feelings
Measured: immediately after breakfast/drink consumption (0 min)
appetite feelings
Measured: 15 min after breakfast/drink consumption
appetite feelings
Measured: 30 min after breakfast/drink consumption
appetite feelings
Measured: 60 min after breakfast/drink consumption
appetite feelings
Measured: 90 min after breakfast/drink consumption
appetite feelings
Measured: 120 min after breakfast/drink consumption
appetite feelings
Measured: 150 min after breakfast/drink consumption
appetite feelings
Measured: 180 min after breakfast/drink consumption
appetite hormones
Measured: fasting (-15 min)
appetite hormones
Measured: immediately after breakfast/drink consumption (0 min)
appetite hormones
Measured: 15 min after breakfast/drink consumption
appetite hormones
Measured: 30 min after breakfast/drink consumption
appetite hormones
Measured: 60 min after breakfast/drink consumption
appetite hormones
Measured: 90 min after breakfast/drink consumption
appetite hormones
Measured: 120 min after breakfast/drink consumption
appetite hormones
Measured: 150 min after breakfast/drink consumption
appetite hormones
Measured: 180 min after breakfast/drink consumption
markers of inflammation
Measured: fasting (-15 min)
markers of inflammation
Measured: immediately after breakfast/drink consumption (0 min)
markers of inflammation
Measured: 15 min after breakfast/drink consumption
markers of inflammation
Measured: 30 min after breakfast/drink consumption
markers of inflammation
Measured: 60 min after breakfast/drink consumption
markers of inflammation
Measured: 90 min after breakfast/drink consumption
markers of inflammation
Measured: 120 min after breakfast/drink consumption
markers of inflammation
Measured: 150 min after breakfast/drink consumption
markers of inflammation
Measured: 180 min after breakfast/drink consumption
markers of glucose metabolism
Measured: fasting (-15 min)
markers of glucose metabolism
Measured: immediately after breakfast/drink consumption (0 min)
markers of glucose metabolism
Measured: 15 min after breakfast/drink consumption
markers of glucose metabolism
Measured: 30 min after breakfast/drink consumption
markers of glucose metabolism
Measured: 60 min after breakfast/drink consumption
markers of glucose metabolism
Measured: 90 min after breakfast/drink consumption
markers of glucose metabolism
Measured: 120 min after breakfast/drink consumption
markers of glucose metabolism
Measured: 150 min after breakfast/drink consumption
markers of glucose metabolism
Measured: 180 min after breakfast/drink consumption
Secondary outcomes (6)
% carbohydrates ad libitum
Measured: 180 min after breakfast/drink consumption
% carbohydrates total day
Measured: One day
% protein ad libitum
Measured: 180 min after breakfast/drink consumption
% protein total day
Measured: One day
% fat
Measured: 180 min after breakfast/drink consumption
% fat total day
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2011 (estimated)
- Study startJan 2011
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harokopio University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, M. Yannakoulia, Harokopio University
- Investigators
- Mary Yannakoulia, PhD, Principal investigator, Harokopio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01495754
- Sponsor's protocol ID
- CofSt3
- Status last verified
- Dec 2011
- First submitted
- 16 Dec 2011
- Last updated
- 20 Dec 2011
- Results posted
- No
- 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 21346100Perakakis N, Kokkinos A, Angelidi AM, Tsilingiris D, Gavrieli A, Yannakoulia M, Tentolouris N, Mantzoros CS. Circulating levels of five proglucagon-derived peptides in response to intravenous or oral glucose or lipids and to a mixed-meal in subjects with normal weight, overweight, and obesity. Clin Nutr. 2022 Sep;41(9):1969-1976. doi: 10.1016/j.clnu.2022.07.001. Epub 2022 Jul 19.
PubMed 35961260Gavrieli A, Fragopoulou E, Mantzoros CS, Yannakoulia M. Gender and body mass index modify the effect of increasing amounts of caffeinated coffee on postprandial glucose and insulin concentrations; a randomized, controlled, clinical trial. Metabolism. 2013 Aug;62(8):1099-106. doi: 10.1016/j.metabol.2013.02.003. Epub 2013 Mar 15.
PubMed 23498899
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Amounts of Coffee on Dietary Intake, Appetite-related Feeling, Appetite Hormones, Glucose Metabolism and Inflammatory Markers of Normal Weight and Overweight/Obese Individuals
- ClinicalTrials.gov ID
- NCT01495754
- Acronym / sponsor ID
- CofSt3
- Conditions
- Obesity, Inflammation
- Keywords
- coffee, overweight/obese, appetite, energy intake, inflammation, glucose metabolism, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Harokopio UniversityUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 20 Dec 2011 (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.
The purpose of the study is to investigate whether different doses of caffeinated 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 in normal weight and overweight/obese participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| coffee3 | Experimental | Other: coffee |
| coffee6 | Experimental | Other: coffee |
| water | Placebo comparator | Other: coffee |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- apparently healthy
- habitual coffee drinkers (>= 1cup of coffee/day)
Key exclusion criteria (10 listed)
- smokers
- restrained eaters (as this was evaluated using the Dutch Eating Behaviour Questionnaire)
- those who reported slimming or any other dietary regime
- athletes
- participants with a known diagnosis of either hypertension, diabetes, impaired glucose tolerance or a fasting blood glucose concentration above 125 mg/dl
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 |
|---|---|---|
| coffeeComparison of different amounts of coffee | Other | coffee3, coffee6, water |
Primary outcome
energy intake ad libitum
Time frame: 180 min after breakfast/drink consumption
total energy intake
Time frame: One day
appetite feelings
Time frame: fasting (-15 min)
appetite feelings
Time frame: immediately after breakfast/drink consumption (0 min)
appetite feelings
Time frame: 15 min after breakfast/drink consumption
appetite feelings
Time frame: 30 min after breakfast/drink consumption
appetite feelings
Time frame: 60 min after breakfast/drink consumption
appetite feelings
Time frame: 90 min after breakfast/drink consumption
appetite feelings
Time frame: 120 min after breakfast/drink consumption
appetite feelings
Time frame: 150 min after breakfast/drink consumption
appetite feelings
Time frame: 180 min after breakfast/drink consumption
appetite hormones
Time frame: fasting (-15 min)
appetite hormones
Time frame: immediately after breakfast/drink consumption (0 min)
appetite hormones
Time frame: 15 min after breakfast/drink consumption
appetite hormones
Time frame: 30 min after breakfast/drink consumption
appetite hormones
Time frame: 60 min after breakfast/drink consumption
appetite hormones
Time frame: 90 min after breakfast/drink consumption
appetite hormones
Time frame: 120 min after breakfast/drink consumption
appetite hormones
Time frame: 150 min after breakfast/drink consumption
appetite hormones
Time frame: 180 min after breakfast/drink consumption
markers of inflammation
Time frame: fasting (-15 min)
markers of inflammation
Time frame: immediately after breakfast/drink consumption (0 min)
markers of inflammation
Time frame: 15 min after breakfast/drink consumption
markers of inflammation
Time frame: 30 min after breakfast/drink consumption
markers of inflammation
Time frame: 60 min after breakfast/drink consumption
markers of inflammation
Time frame: 90 min after breakfast/drink consumption
markers of inflammation
Time frame: 120 min after breakfast/drink consumption
markers of inflammation
Time frame: 150 min after breakfast/drink consumption
markers of inflammation
Time frame: 180 min after breakfast/drink consumption
markers of glucose metabolism
Time frame: fasting (-15 min)
markers of glucose metabolism
Time frame: immediately after breakfast/drink consumption (0 min)
markers of glucose metabolism
Time frame: 15 min after breakfast/drink consumption
markers of glucose metabolism
Time frame: 30 min after breakfast/drink consumption
markers of glucose metabolism
Time frame: 60 min after breakfast/drink consumption
markers of glucose metabolism
Time frame: 90 min after breakfast/drink consumption
markers of glucose metabolism
Time frame: 120 min after breakfast/drink consumption
markers of glucose metabolism
Time frame: 150 min after breakfast/drink consumption
markers of glucose metabolism
Time frame: 180 min after breakfast/drink consumption
6 secondary outcomes
% carbohydrates ad libitum
Time frame: 180 min after breakfast/drink consumption
% carbohydrates total day
Time frame: One day
% protein ad libitum
Time frame: 180 min after breakfast/drink consumption
% protein total day
Time frame: One day
% fat
Time frame: 180 min after breakfast/drink consumption
% fat total day
Time frame: One day
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 20 Dec 2011.
- Background: 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.
- Derived from this study: PubMed 35961260Perakakis N, Kokkinos A, Angelidi AM, Tsilingiris D, Gavrieli A, Yannakoulia M, Tentolouris N, Mantzoros CS. Circulating levels of five proglucagon-derived peptides in response to intravenous or oral glucose or lipids and to a mixed-meal in subjects with normal weight, overweight, and obesity. Clin Nutr. 2022 Sep;41(9):1969-1976. doi: 10.1016/j.clnu.2022.07.001. Epub 2022 Jul 19.
- Derived from this study: PubMed 23498899Gavrieli A, Fragopoulou E, Mantzoros CS, Yannakoulia M. Gender and body mass index modify the effect of increasing amounts of caffeinated coffee on postprandial glucose and insulin concentrations; a randomized, controlled, clinical trial. Metabolism. 2013 Aug;62(8):1099-106. doi: 10.1016/j.metabol.2013.02.003. Epub 2013 Mar 15.
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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 principal investigator
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 coffee in people with Obesity and Inflammation, 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 10 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 20 Dec 2011. 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. 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?
energy intake ad libitum (time frame: 180 min after breakfast/drink consumption). The study lists 38 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 NCT01495754, which also lists 3 linked publications.
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 20 Dec 2011.