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| Name | Class |
|---|---|
| Beth Israel Deaconess Medical Center | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| caffeinated coffee | Experimental | 200 mL caffeinated coffee with 3 mg caffeine per kg body weight |
|
| decaffeinated coffee | Experimental | 200 mL decaffeinated coffee, same amount as caffeinated coffee |
|
| Water | Experimental | 200 mL, control intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| caffeinated and decaffeinated coffee | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary Yannakoulia, PhD | Harokopio University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Metabolic Unit of the Department of Nutrition and Dietetics, Harokopio University | Athens | 17671 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21346100 | Derived | 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. |
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February-Mai 2009, Athens region, voluntarily recruitment
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| ID | Title | Description |
|---|---|---|
| FG000 | Caffeinated Coffee/Decaffeinated Coffee/Water | 200 ml instant caffeinated coffee with 3 mg caffeine/kg body weight or instant decaffeinated coffee or water. All participants received all interventions without exception in a random order. Three combinations of treatment sequences were used:
Each treatment was separated by the other by at least one week interval. The first volunteer entered the study received the first combination, the second volunteer the second combiation, the third volunteer the third combination, the forth volunteer the first combination of treatments, etc. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | ug*h/mL | 15 min before ingestion to 3 hr post ingestion |
|
3 h
blood pressure and heart rate assessment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Caffeinated Coffee | 200 mL, coffee containing 3 mg caffeine/kg body weight |
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the results cannot be generalized to other population groups, as participants were selected according to specific criteria.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mary Yannakoulia | Harokopio University | 00302109549175 | myianna@hua.gr |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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. | 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. | 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. | 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. | 15 min before ingestion to 3 hr post ingestion |
| Energy ad Libitum Meal | The energy of first meal 3 hr after ingestion | 3 hr post ingestion |
| Total Energy Intake | the energy consumed at breakfast, ad libitum meal and rest of the experimental day | 1 d |
| 15 min before ingestion to 21/2 hr post ingestion |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Water |
200 mL |
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | pg*h/mL | 15 min before ingestion to 3 hr post ingestion |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | ug*h/mL | 15 min before ingestion to 3 hr post ingestion |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | ug*h/mL | 15 min before ingestion to 3 h post ingestion |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | pg*h/mL | 15 min before ingestion to 3 hr post ingestion |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | pg*h/mL | 15 min before ingestion to 3 hr post ingestion |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | mg*h/dl | 15 min before ingestion to 3 hr post ingestion |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | lag time (min) *h | 15 min before ingestion to 21/2 hr post ingestion |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | uU*h/ml | 15 min before ingestion to 3 hr post ingestion |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | ug*h/dL | 15 min before ingestion to 3 hr post ingestion |
|
|
|
| Primary | Energy ad Libitum Meal | The energy of first meal 3 hr after ingestion | Posted | Mean | Standard Deviation | kcal | 3 hr post ingestion |
|
|
|
| Primary | Total Energy Intake | the energy consumed at breakfast, ad libitum meal and rest of the experimental day | Posted | Mean | Standard Deviation | kcal | 1 d |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Decaffeinated Coffee | 200 mL decaffeinated coffee, same amount as caffeinated coffee | 0 | 16 | 0 | 16 |
| EG002 | Water | 200 mL | 0 | 16 | 0 | 16 |
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