Acute Effects of Coffee on Appetite and Inflammation Markers, Glucose Metabolism and Energy Intake
Primary Purpose
Health
Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
caffeinated and decaffeinated coffee
Sponsored by

About this trial
This is an interventional treatment trial for Health focused on measuring coffee, appetite, energy intake, inflammation, cortisol, glucose, randomized controlled trial
Eligibility Criteria
Inclusion Criteria:
- healthy
- non-obese
Exclusion Criteria:
- 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
Sites / Locations
- Metabolic Unit of the Department of Nutrition and Dietetics, Harokopio University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
caffeinated coffee
decaffeinated coffee
Water
Arm Description
200 mL caffeinated coffee with 3 mg caffeine per kg body weight
200 mL decaffeinated coffee, same amount as caffeinated coffee
200 mL, control intervention
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
Energy ad Libitum Meal
The energy of first meal 3 hr after ingestion
Total Energy Intake
the energy consumed at breakfast, ad libitum meal and rest of the experimental day
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01174576
First Posted
July 26, 2010
Last Updated
July 26, 2013
Sponsor
Harokopio University
Collaborators
Beth Israel Deaconess Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01174576
Brief Title
Acute Effects of Coffee on Appetite and Inflammation Markers, Glucose Metabolism and Energy Intake
Official Title
Acute Effects of Caffeinated and Decaffeinated Coffee Consumption on Energy Intake, Appetite, Inflammation and Glucose Metabolism
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harokopio University
Collaborators
Beth Israel Deaconess Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Health
Keywords
coffee, appetite, energy intake, inflammation, cortisol, glucose, randomized controlled trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
caffeinated coffee
Arm Type
Experimental
Arm Description
200 mL caffeinated coffee with 3 mg caffeine per kg body weight
Arm Title
decaffeinated coffee
Arm Type
Experimental
Arm Description
200 mL decaffeinated coffee, same amount as caffeinated coffee
Arm Title
Water
Arm Type
Experimental
Arm Description
200 mL, control intervention
Intervention Type
Other
Intervention Name(s)
caffeinated and decaffeinated coffee
Intervention Description
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
Primary Outcome Measure Information:
Title
Ghrelin Total Area Under the Curve
Description
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.
Time Frame
15 min before ingestion to 3 hr post ingestion
Title
Peptide Tyrosine Tyrosine (PYY) Total Area Under the Curve
Description
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.
Time Frame
15 min before ingestion to 3 hr post ingestion
Title
Glucagon-like Peptide-1 (GLP-1) Total Area Under the Curve
Description
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.
Time Frame
15 min before ingestion to 3 hr post ingestion
Title
Adiponectin Total Area Under the Curve
Description
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.
Time Frame
15 min before ingestion to 3 h post ingestion
Title
Inteleukin-6 Total Area Under the Curve
Description
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.
Time Frame
15 min before ingestion to 3 hr post ingestion
Title
Interleukin-18 Total Area Under the Curve
Description
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.
Time Frame
15 min before ingestion to 3 hr post ingestion
Title
Glucose Total Area Under the Curve
Description
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.
Time Frame
15 min before ingestion to 3 hr post ingestion
Title
Insulin Total Area Under the Curve
Description
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.
Time Frame
15 min before ingestion to 3 hr post ingestion
Title
Cortisol Total Area Under the Curve
Description
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.
Time Frame
15 min before ingestion to 3 hr post ingestion
Title
Energy ad Libitum Meal
Description
The energy of first meal 3 hr after ingestion
Time Frame
3 hr post ingestion
Title
Total Energy Intake
Description
the energy consumed at breakfast, ad libitum meal and rest of the experimental day
Time Frame
1 d
Secondary Outcome Measure Information:
Title
Serum Antioxidant Capacity Total Area Under the Curve
Description
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.
Time Frame
15 min before ingestion to 21/2 hr post ingestion
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
healthy
non-obese
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Yannakoulia, PhD
Organizational Affiliation
Harokopio University
Official's Role
Study Director
Facility Information:
Facility Name
Metabolic Unit of the Department of Nutrition and Dietetics, Harokopio University
City
Athens
ZIP/Postal Code
17671
Country
Greece
12. IPD Sharing Statement
Citations:
PubMed Identifier
21346100
Citation
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.
Results Reference
derived
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Acute Effects of Coffee on Appetite and Inflammation Markers, Glucose Metabolism and Energy Intake
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