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

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ClinicalTrials.gov Identifier: NCT01174576
Recruitment Status : Completed
First Posted : August 3, 2010
Results First Posted : September 30, 2013
Last Update Posted : September 30, 2013
Sponsor:
Collaborator:
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
M. Yannakoulia, Harokopio University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Health
Intervention Other: caffeinated and decaffeinated coffee
Enrollment 16
Recruitment Details February-Mai 2009, Athens region, voluntarily recruitment
Pre-assignment Details  
Arm/Group Title Caffeinated Coffee/Decaffeinated Coffee/Water
Hide 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:

  1. Caffeinated coffee, then decaffeinated coffee, then water
  2. Decaffeinated coffee first, then water, then caffeinated coffee
  3. 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 [1]
Completed 16
Not Completed 0
[1]
All participants received all interventions without exception.
Arm/Group Title Group 1
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
<=18 years
0
   0.0%
Between 18 and 65 years
16
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants
27.8  (5.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Female
0
   0.0%
Male
16
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Greece Number Analyzed 16 participants
16
1.Primary Outcome
Title Ghrelin Total Area Under the Curve
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Caffeinated Coffee Decaffeinated Coffee Water
Hide Arm/Group Description:
200 mL, 3 mg caffeine/kg body weight
200 mL, same amount as caffeinated coffee
200 mL
Overall Number of Participants Analyzed 16 16 16
Mean (Standard Deviation)
Unit of Measure: ug*h/mL
2669  (786) 2593  (778) 2672  (902)
2.Primary Outcome
Title Peptide Tyrosine Tyrosine (PYY) Total Area Under the Curve
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Caffeinated Coffee Decaffeinated Coffee Water
Hide Arm/Group Description:
200 mL, 3 mg caffeine/kg body weight
200 mL, same amount as caffeinated coffee
200 mL
Overall Number of Participants Analyzed 16 16 16
Mean (Standard Deviation)
Unit of Measure: pg*h/mL
251  (136) 286  (138) 259  (158)
3.Primary Outcome
Title Glucagon-like Peptide-1 (GLP-1) Total Area Under the Curve
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Caffeinated Coffee Decaffeinated Coffee Water
Hide Arm/Group Description:
200 mL, 3 mg caffeine/kg body weight
200 mL, same amount as caffeinated coffee
200 mL
Overall Number of Participants Analyzed 16 16 16
Mean (Standard Deviation)
Unit of Measure: ug*h/mL
43  (61) 45  (69) 61  (122)
4.Primary Outcome
Title Adiponectin Total Area Under the Curve
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Caffeinated Coffee Decaffeinated Coffee Water
Hide Arm/Group Description:
200 mL, 3 mg caffeine/kg body weight
200 mL, same amount as caffeinated coffee
200 mL
Overall Number of Participants Analyzed 16 16 16
Mean (Standard Deviation)
Unit of Measure: 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Caffeinated Coffee Decaffeinated Coffee Water
Hide Arm/Group Description:
200 mL, 3 mg caffeine/kg body weight
200 mL, same amount as caffeineated coffee
200 mL
Overall Number of Participants Analyzed 16 16 16
Mean (Standard Deviation)
Unit of Measure: 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Caffeinated Coffee Decaffeinated Coffee Water
Hide Arm/Group Description:
200 mL, 3 mg caffeine/kg body weight
200 mL, same amount as caffeinated coffee
200 mL
Overall Number of Participants Analyzed 16 16 16
Mean (Standard Deviation)
Unit of Measure: pg*h/mL
818  (289) 777  (280) 786  (273)
7.Primary Outcome
Title Glucose Total Area Under the Curve
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Caffeinated Coffee Decaffeinated Coffee Water
Hide Arm/Group Description:
200 ml instant caffeinated coffee with 3 mg caffeine/kg body weight
200 ml instant decaffeinated coffee
200 ml water
Overall Number of Participants Analyzed 16 16 16
Mean (Standard Deviation)
Unit of Measure: mg*h/dl
336  (22) 329  (20) 323  (20)
8.Primary Outcome
Title Insulin Total Area Under the Curve
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Caffeinated Coffee Decaffeinated Coffee Water
Hide Arm/Group Description:
200 ml instant caffeinated coffee with 3 mg caffeine/kg body weight
200 ml instant decaffeinated coffee
200 ml water
Overall Number of Participants Analyzed 16 16 16
Mean (Standard Deviation)
Unit of Measure: uU*h/ml
54  (14) 52  (16) 52  (16)
9.Primary Outcome
Title Cortisol Total Area Under the Curve
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Caffeinated Coffee Decaffeinated Coffee Water
Hide Arm/Group Description:
200 mL, 3 mg caffeine/kg body weight
200 mL, same amount as caffeinated coffee
200 mL
Overall Number of Participants Analyzed 16 16 16
Mean (Standard Deviation)
Unit of Measure: ug*h/dL
43.2  (11.3) 39.8  (10.5) 35.0  (6.9)
10.Primary Outcome
Title Energy ad Libitum Meal
Hide Description The energy of first meal 3 hr after ingestion
Time Frame 3 hr post ingestion
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Caffeinated Coffee Decaffeinated Coffee Water
Hide Arm/Group Description:
200 mL, 3 mg caffeine/kg body weight
200 mL, same amount as caffeinated coffee
200 mL
Overall Number of Participants Analyzed 16 16 16
Mean (Standard Deviation)
Unit of Measure: kcal
1749  (407) 1720  (402) 1750  (442)
11.Primary Outcome
Title Total Energy Intake
Hide Description the energy consumed at breakfast, ad libitum meal and rest of the experimental day
Time Frame 1 d
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Caffeinated Coffee Decaffeinated Coffee Water
Hide Arm/Group Description:
200 mL, 3 mg caffeine/kg body weight
200 mL, same amount as caffeinated coffee
200 mL
Overall Number of Participants Analyzed 16 16 16
Mean (Standard Deviation)
Unit of Measure: kcal
3223  (735) 3445  (871) 3302  (971)
12.Secondary Outcome
Title Serum Antioxidant Capacity Total Area Under the Curve
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Caffeinated Coffee Decaffeinated Coffee Water
Hide Arm/Group Description:
200 mL, 3 mg caffeine/ kg body weight
200 mL, same amount as caffeinated coffee
200 mL
Overall Number of Participants Analyzed 16 16 16
Mean (Standard Deviation)
Unit of Measure: lag time (min) *h
102  (30) 104  (37) 108  (32)
Time Frame 3 h
Adverse Event Reporting Description blood pressure and heart rate assessment
 
Arm/Group Title Caffeinated Coffee Decaffeinated Coffee Water
Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Caffeinated Coffee Decaffeinated Coffee Water
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/16 (0.00%)   0/16 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Caffeinated Coffee Decaffeinated Coffee Water
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/16 (0.00%)   0/16 (0.00%) 
the results cannot be generalized to other population groups, as participants were selected according to specific criteria.
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.
Results Point of Contact
Name/Title: Dr. Mary Yannakoulia
Organization: Harokopio University
Phone: 00302109549175
Responsible Party: M. Yannakoulia, Harokopio University
ClinicalTrials.gov Identifier: NCT01174576     History of Changes
Other Study ID Numbers: CofSt
First Submitted: July 26, 2010
First Posted: August 3, 2010
Results First Submitted: September 4, 2012
Results First Posted: September 30, 2013
Last Update Posted: September 30, 2013