- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01495754
Effects of Different Coffee Amounts on Energy Intake, Appetite, Glucose Metabolism and Inflammatory Markers
December 19, 2011 updated by: M. Yannakoulia, Harokopio University
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
33
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Athens, Greece, 17671
- Metabolic Unit of the Department of Nutrition and Dietetics, Harokopio University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- apparently healthy
- habitual coffee drinkers (>= 1cup of coffee/day)
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: coffee3
|
Comparison of different amounts of coffee
|
|
Experimental: coffee6
|
Comparison of different amounts of coffee
|
|
Placebo Comparator: water
|
Comparison of different amounts of coffee
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
energy intake ad libitum
Time Frame: 180 min after breakfast/drink consumption
|
180 min after breakfast/drink consumption
|
|
total energy intake
Time Frame: One day
|
One day
|
|
appetite feelings
Time Frame: fasting (-15 min)
|
fasting (-15 min)
|
|
appetite feelings
Time Frame: immediately after breakfast/drink consumption (0 min)
|
immediately after breakfast/drink consumption (0 min)
|
|
appetite feelings
Time Frame: 15 min after breakfast/drink consumption
|
15 min after breakfast/drink consumption
|
|
appetite feelings
Time Frame: 30 min after breakfast/drink consumption
|
30 min after breakfast/drink consumption
|
|
appetite feelings
Time Frame: 60 min after breakfast/drink consumption
|
60 min after breakfast/drink consumption
|
|
appetite feelings
Time Frame: 90 min after breakfast/drink consumption
|
90 min after breakfast/drink consumption
|
|
appetite feelings
Time Frame: 120 min after breakfast/drink consumption
|
120 min after breakfast/drink consumption
|
|
appetite feelings
Time Frame: 150 min after breakfast/drink consumption
|
150 min after breakfast/drink consumption
|
|
appetite feelings
Time Frame: 180 min after breakfast/drink consumption
|
180 min after breakfast/drink consumption
|
|
appetite hormones
Time Frame: fasting (-15 min)
|
fasting (-15 min)
|
|
appetite hormones
Time Frame: immediately after breakfast/drink consumption (0 min)
|
immediately after breakfast/drink consumption (0 min)
|
|
appetite hormones
Time Frame: 15 min after breakfast/drink consumption
|
15 min after breakfast/drink consumption
|
|
appetite hormones
Time Frame: 30 min after breakfast/drink consumption
|
30 min after breakfast/drink consumption
|
|
appetite hormones
Time Frame: 60 min after breakfast/drink consumption
|
60 min after breakfast/drink consumption
|
|
appetite hormones
Time Frame: 90 min after breakfast/drink consumption
|
90 min after breakfast/drink consumption
|
|
appetite hormones
Time Frame: 120 min after breakfast/drink consumption
|
120 min after breakfast/drink consumption
|
|
appetite hormones
Time Frame: 150 min after breakfast/drink consumption
|
150 min after breakfast/drink consumption
|
|
appetite hormones
Time Frame: 180 min after breakfast/drink consumption
|
180 min after breakfast/drink consumption
|
|
markers of inflammation
Time Frame: fasting (-15 min)
|
fasting (-15 min)
|
|
markers of inflammation
Time Frame: immediately after breakfast/drink consumption (0 min)
|
immediately after breakfast/drink consumption (0 min)
|
|
markers of inflammation
Time Frame: 15 min after breakfast/drink consumption
|
15 min after breakfast/drink consumption
|
|
markers of inflammation
Time Frame: 30 min after breakfast/drink consumption
|
30 min after breakfast/drink consumption
|
|
markers of inflammation
Time Frame: 60 min after breakfast/drink consumption
|
60 min after breakfast/drink consumption
|
|
markers of inflammation
Time Frame: 90 min after breakfast/drink consumption
|
90 min after breakfast/drink consumption
|
|
markers of inflammation
Time Frame: 120 min after breakfast/drink consumption
|
120 min after breakfast/drink consumption
|
|
markers of inflammation
Time Frame: 150 min after breakfast/drink consumption
|
150 min after breakfast/drink consumption
|
|
markers of inflammation
Time Frame: 180 min after breakfast/drink consumption
|
180 min after breakfast/drink consumption
|
|
markers of glucose metabolism
Time Frame: fasting (-15 min)
|
fasting (-15 min)
|
|
markers of glucose metabolism
Time Frame: immediately after breakfast/drink consumption (0 min)
|
immediately after breakfast/drink consumption (0 min)
|
|
markers of glucose metabolism
Time Frame: 15 min after breakfast/drink consumption
|
15 min after breakfast/drink consumption
|
|
markers of glucose metabolism
Time Frame: 30 min after breakfast/drink consumption
|
30 min after breakfast/drink consumption
|
|
markers of glucose metabolism
Time Frame: 60 min after breakfast/drink consumption
|
60 min after breakfast/drink consumption
|
|
markers of glucose metabolism
Time Frame: 90 min after breakfast/drink consumption
|
90 min after breakfast/drink consumption
|
|
markers of glucose metabolism
Time Frame: 120 min after breakfast/drink consumption
|
120 min after breakfast/drink consumption
|
|
markers of glucose metabolism
Time Frame: 150 min after breakfast/drink consumption
|
150 min after breakfast/drink consumption
|
|
markers of glucose metabolism
Time Frame: 180 min after breakfast/drink consumption
|
180 min after breakfast/drink consumption
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
% carbohydrates ad libitum
Time Frame: 180 min after breakfast/drink consumption
|
180 min after breakfast/drink consumption
|
|
% carbohydrates total day
Time Frame: One day
|
One day
|
|
% protein ad libitum
Time Frame: 180 min after breakfast/drink consumption
|
180 min after breakfast/drink consumption
|
|
% protein total day
Time Frame: One day
|
One day
|
|
% fat
Time Frame: 180 min after breakfast/drink consumption
|
180 min after breakfast/drink consumption
|
|
% fat total day
Time Frame: One day
|
One day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mary Yannakoulia, PhD, Harokopio University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Perakakis 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.
- 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.
- Gavrieli 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2011
Primary Completion (Actual)
June 1, 2011
Study Completion (Actual)
June 1, 2011
Study Registration Dates
First Submitted
December 16, 2011
First Submitted That Met QC Criteria
December 19, 2011
First Posted (Estimate)
December 20, 2011
Study Record Updates
Last Update Posted (Estimate)
December 20, 2011
Last Update Submitted That Met QC Criteria
December 19, 2011
Last Verified
December 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CofSt3
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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