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

This study has been completed.
Sponsor:
Collaborator:
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
M. Yannakoulia, Harokopio University
ClinicalTrials.gov Identifier:
NCT01174576
First received: July 26, 2010
Last updated: July 26, 2013
Last verified: July 2013
Results First Received: September 4, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Health
Intervention: Other: caffeinated and decaffeinated coffee

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
February-Mai 2009, Athens region, voluntarily recruitment

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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:

  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.


Participant Flow:   Overall Study
    Caffeinated Coffee/Decaffeinated Coffee/Water  
STARTED     16 [1]
COMPLETED     16  
NOT COMPLETED     0  
[1] All participants received all interventions without exception.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Group 1 No text entered.

Baseline Measures
    Group 1  
Number of Participants  
[units: participants]
  16  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     16  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  27.8  ± 5.2  
Gender  
[units: participants]
 
Female     0  
Male     16  
Region of Enrollment  
[units: participants]
 
Greece     16  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Ghrelin Total Area Under the Curve   [ Time Frame: 15 min before ingestion to 3 hr post ingestion ]

2.  Primary:   Peptide Tyrosine Tyrosine (PYY) Total Area Under the Curve   [ Time Frame: 15 min before ingestion to 3 hr post ingestion ]

3.  Primary:   Glucagon-like Peptide-1 (GLP-1) Total Area Under the Curve   [ Time Frame: 15 min before ingestion to 3 hr post ingestion ]

4.  Primary:   Adiponectin Total Area Under the Curve   [ Time Frame: 15 min before ingestion to 3 h post ingestion ]

5.  Primary:   Inteleukin-6 Total Area Under the Curve   [ Time Frame: 15 min before ingestion to 3 hr post ingestion ]

6.  Primary:   Interleukin-18 Total Area Under the Curve   [ Time Frame: 15 min before ingestion to 3 hr post ingestion ]

7.  Primary:   Glucose Total Area Under the Curve   [ Time Frame: 15 min before ingestion to 3 hr post ingestion ]

8.  Primary:   Insulin Total Area Under the Curve   [ Time Frame: 15 min before ingestion to 3 hr post ingestion ]

9.  Primary:   Cortisol Total Area Under the Curve   [ Time Frame: 15 min before ingestion to 3 hr post ingestion ]

10.  Primary:   Energy ad Libitum Meal   [ Time Frame: 3 hr post ingestion ]

11.  Primary:   Total Energy Intake   [ Time Frame: 1 d ]

12.  Secondary:   Serum Antioxidant Capacity Total Area Under the Curve   [ Time Frame: 15 min before ingestion to 21/2 hr post ingestion ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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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.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
the results cannot be generalized to other population groups, as participants were selected according to specific criteria.  


Results Point of Contact:  
Name/Title: Dr. Mary Yannakoulia
Organization: Harokopio University
phone: 00302109549175
e-mail: myianna@hua.gr


No publications provided by Harokopio University

Publications automatically indexed to this study:

Responsible Party: M. Yannakoulia, Harokopio University
ClinicalTrials.gov Identifier: NCT01174576     History of Changes
Other Study ID Numbers: CofSt
Study First Received: July 26, 2010
Results First Received: September 4, 2012
Last Updated: July 26, 2013
Health Authority: Greece: Ethics Committee