Acute Effects of Coffee on Appetite and Inflammation Markers, Glucose Metabolism and Energy Intake

• Sponsor: Harokopio University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01174576
• Collaborator: Beth Israel Deaconess Medical Center (Other)
• Enrollment: 16
• Location: 1
• Arms: 3
• Duration (Months): 2.9
• Patients Per Site Per Month: 5.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Health	Other: caffeinated and decaffeinated coffee	N/A

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

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Acute Effects of Caffeinated and Decaffeinated Coffee Consumption on Energy Intake, Appetite, Inflammation and Glucose Metabolism
• Study Start Date: Feb 1, 2009
• Actual Primary Completion Date: May 1, 2009
• Actual Study Completion Date: May 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: caffeinated coffee 200 mL caffeinated coffee with 3 mg caffeine per kg body weight	Other: caffeinated and decaffeinated coffee; 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
Experimental: decaffeinated coffee 200 mL decaffeinated coffee, same amount as caffeinated coffee	Other: caffeinated and decaffeinated coffee; 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
Experimental: Water 200 mL, control intervention	Other: caffeinated and decaffeinated coffee; 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

Outcome Measures

Primary Outcome Measures

1. Ghrelin Total Area Under the Curve [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.

2. Peptide Tyrosine Tyrosine (PYY) Total Area Under the Curve [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.

3. Glucagon-like Peptide-1 (GLP-1) Total Area Under the Curve [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.

4. Adiponectin Total Area Under the Curve [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.

5. Inteleukin-6 Total Area Under the Curve [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.

6. Interleukin-18 Total Area Under the Curve [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.

7. Glucose Total Area Under the Curve [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.

8. Insulin Total Area Under the Curve [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.

9. Cortisol Total Area Under the Curve [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.

10. Energy ad Libitum Meal [3 hr post ingestion]

    The energy of first meal 3 hr after ingestion

11. Total Energy Intake [1 d]

    the energy consumed at breakfast, ad libitum meal and rest of the experimental day

Secondary Outcome Measures

1. Serum Antioxidant Capacity Total Area Under the Curve [15 min before ingestion to 21/2 hr post ingestion]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Metabolic Unit of the Department of Nutrition and Dietetics, Harokopio University	Athens		Greece	17671

Sponsors and Collaborators

• Harokopio University
• Beth Israel Deaconess Medical Center

Investigators

• Study Director: Mary Yannakoulia, PhD, Harokopio University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: M. Yannakoulia, PhD, Harokopio University
• ClinicalTrials.gov Identifier: NCT01174576
• Other Study ID Numbers: CofSt
• First Posted: Aug 3, 2010
• Last Update Posted: Sep 30, 2013
• Last Verified: Jul 1, 2013

• Keywords provided by M. Yannakoulia, PhD, Harokopio University: coffee; appetite; energy intake; inflammation; cortisol; glucose; randomized controlled trial
• Additional relevant MeSH terms: Inflammation

Study Results

Participant Flow

Recruitment Details	February-Mai 2009, Athens region, voluntarily recruitment

Arm/Group Title	Caffeinated Coffee/Decaffeinated Coffee/Water
Arm/Group Description	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: Caffeinated coffee, then decaffeinated coffee, then water Decaffeinated coffee first, then water, then caffeinated coffee Water first, then caffeinated coffee, then decaffeinated coffee. 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.
Period Title: Overall Study
STARTED	16
COMPLETED	16
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Group 1
Arm/Group Description
Overall Participants	16
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	16 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	27.8 (5.2)
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	16 100%
Region of Enrollment (participants) [Number]
Greece	16 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Caffeinated Coffee	Decaffeinated Coffee	Water
Arm/Group Description	200 mL, 3 mg caffeine/kg body weight	200 mL, same amount as caffeinated coffee	200 mL
Measure Participants	16	16	16
Mean (Standard Deviation) [ug*h/mL]	2669 (786)	2593 (778)	2672 (902)

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Caffeinated Coffee	Decaffeinated Coffee	Water
Arm/Group Description	200 mL, 3 mg caffeine/kg body weight	200 mL, same amount as caffeinated coffee	200 mL
Measure Participants	16	16	16
Mean (Standard Deviation) [pg*h/mL]	251 (136)	286 (138)	259 (158)

3. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Caffeinated Coffee	Decaffeinated Coffee	Water
Arm/Group Description	200 mL, 3 mg caffeine/kg body weight	200 mL, same amount as caffeinated coffee	200 mL
Measure Participants	16	16	16
Mean (Standard Deviation) [ug*h/mL]	43 (61)	45 (69)	61 (122)

4. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Caffeinated Coffee	Decaffeinated Coffee	Water
Arm/Group Description	200 mL, 3 mg caffeine/kg body weight	200 mL, same amount as caffeinated coffee	200 mL
Measure Participants	16	16	16
Mean (Standard Deviation) [ug*h/mL]	22.7 (8.8)	22.6 (10.2)	22.6 (11.0)

5. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Caffeinated Coffee	Decaffeinated Coffee	Water
Arm/Group Description	200 mL, 3 mg caffeine/kg body weight	200 mL, same amount as caffeineated coffee	200 mL
Measure Participants	16	16	16
Mean (Standard Deviation) [pg*h/mL]	5.4 (2.1)	5.5 (2.5)	6.0 (2.6)

6. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Caffeinated Coffee	Decaffeinated Coffee	Water
Arm/Group Description	200 mL, 3 mg caffeine/kg body weight	200 mL, same amount as caffeinated coffee	200 mL
Measure Participants	16	16	16
Mean (Standard Deviation) [pg*h/mL]	818 (289)	777 (280)	786 (273)

7. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Caffeinated Coffee	Decaffeinated Coffee	Water
Arm/Group Description	200 ml instant caffeinated coffee with 3 mg caffeine/kg body weight	200 ml instant decaffeinated coffee	200 ml water
Measure Participants	16	16	16
Mean (Standard Deviation) [mg*h/dl]	336 (22)	329 (20)	323 (20)

8. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Caffeinated Coffee	Decaffeinated Coffee	Water
Arm/Group Description	200 mL, 3 mg caffeine/ kg body weight	200 mL, same amount as caffeinated coffee	200 mL
Measure Participants	16	16	16
Mean (Standard Deviation) [lag time (min) *h]	102 (30)	104 (37)	108 (32)

9. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Caffeinated Coffee	Decaffeinated Coffee	Water
Arm/Group Description	200 ml instant caffeinated coffee with 3 mg caffeine/kg body weight	200 ml instant decaffeinated coffee	200 ml water
Measure Participants	16	16	16
Mean (Standard Deviation) [uU*h/ml]	54 (14)	52 (16)	52 (16)

10. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Caffeinated Coffee	Decaffeinated Coffee	Water
Arm/Group Description	200 mL, 3 mg caffeine/kg body weight	200 mL, same amount as caffeinated coffee	200 mL
Measure Participants	16	16	16
Mean (Standard Deviation) [ug*h/dL]	43.2 (11.3)	39.8 (10.5)	35.0 (6.9)

11. Primary Outcome

Title	Energy ad Libitum Meal
Description	The energy of first meal 3 hr after ingestion
Time Frame	3 hr post ingestion

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Caffeinated Coffee	Decaffeinated Coffee	Water
Arm/Group Description	200 mL, 3 mg caffeine/kg body weight	200 mL, same amount as caffeinated coffee	200 mL
Measure Participants	16	16	16
Mean (Standard Deviation) [kcal]	1749 (407)	1720 (402)	1750 (442)

12. Primary Outcome

Title	Total Energy Intake
Description	the energy consumed at breakfast, ad libitum meal and rest of the experimental day
Time Frame	1 d

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Caffeinated Coffee	Decaffeinated Coffee	Water
Arm/Group Description	200 mL, 3 mg caffeine/kg body weight	200 mL, same amount as caffeinated coffee	200 mL
Measure Participants	16	16	16
Mean (Standard Deviation) [kcal]	3223 (735)	3445 (871)	3302 (971)

Adverse Events

Time Frame	3 h
Adverse Event Reporting Description	blood pressure and heart rate assessment
Arm/Group Title	Caffeinated Coffee		Decaffeinated Coffee		Water
Arm/Group Description	200 mL, coffee containing 3 mg caffeine/kg body weight		200 mL decaffeinated coffee, same amount as caffeinated coffee		200 mL
All Cause Mortality
	Caffeinated Coffee		Decaffeinated Coffee		Water
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Caffeinated Coffee		Decaffeinated Coffee		Water
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/16 (0%)		0/16 (0%)
Other (Not Including Serious) Adverse Events
	Caffeinated Coffee		Decaffeinated Coffee		Water
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/16 (0%)		0/16 (0%)

Limitations/Caveats

the results cannot be generalized to other population groups, as participants were selected according to specific criteria.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.