Back to resultsEffects of Different Coffee Amounts on Energy Intake, Appetite, Glucose Metabolism and Inflammatory Markers
Primary Purpose
Obesity, Inflammation
Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
coffee
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring coffee, overweight/obese, appetite, energy intake, inflammation, glucose metabolism, randomized controlled trial
Eligibility Criteria
Inclusion Criteria:
- apparently healthy
- habitual coffee drinkers (>= 1cup of coffee/day)
Exclusion Criteria:
- smokers
- restrained eaters (as this was evaluated using the Dutch Eating Behaviour Questionnaire)
- those who reported slimming or any other dietary regime
- athletes
- 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,
- 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
Placebo Comparator
Arm Label
coffee3
coffee6
water
Arm Description
Outcomes
Primary Outcome Measures
energy intake ad libitum
total energy intake
appetite feelings
appetite feelings
appetite feelings
appetite feelings
appetite feelings
appetite feelings
appetite feelings
appetite feelings
appetite feelings
appetite hormones
appetite hormones
appetite hormones
appetite hormones
appetite hormones
appetite hormones
appetite hormones
appetite hormones
appetite hormones
markers of inflammation
markers of inflammation
markers of inflammation
markers of inflammation
markers of inflammation
markers of inflammation
markers of inflammation
markers of inflammation
markers of inflammation
markers of glucose metabolism
markers of glucose metabolism
markers of glucose metabolism
markers of glucose metabolism
markers of glucose metabolism
markers of glucose metabolism
markers of glucose metabolism
markers of glucose metabolism
markers of glucose metabolism
Secondary Outcome Measures
% carbohydrates ad libitum
% carbohydrates total day
% protein ad libitum
% protein total day
% fat
% fat total day
Full Information
NCT ID
NCT01495754
First Posted
December 16, 2011
Last Updated
December 19, 2011
Sponsor
Harokopio University
1. Study Identification
Unique Protocol Identification Number
NCT01495754
Brief Title
Effects of Different Coffee Amounts on Energy Intake, Appetite, Glucose Metabolism and Inflammatory Markers
Official Title
The Effect of Different Amounts of Coffee on Dietary Intake, Appetite-related Feeling, Appetite Hormones, Glucose Metabolism and Inflammatory Markers of Normal Weight and Overweight/Obese Individuals
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harokopio University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to investigate whether different doses of caffeinated 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 in normal weight and overweight/obese participants.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Inflammation
Keywords
coffee, overweight/obese, appetite, energy intake, inflammation, glucose metabolism, randomized controlled trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
coffee3
Arm Type
Experimental
Arm Title
coffee6
Arm Type
Experimental
Arm Title
water
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
coffee
Intervention Description
Comparison of different amounts of coffee
Primary Outcome Measure Information:
Title
energy intake ad libitum
Time Frame
180 min after breakfast/drink consumption
Title
total energy intake
Time Frame
One day
Title
appetite feelings
Time Frame
fasting (-15 min)
Title
appetite feelings
Time Frame
immediately after breakfast/drink consumption (0 min)
Title
appetite feelings
Time Frame
15 min after breakfast/drink consumption
Title
appetite feelings
Time Frame
30 min after breakfast/drink consumption
Title
appetite feelings
Time Frame
60 min after breakfast/drink consumption
Title
appetite feelings
Time Frame
90 min after breakfast/drink consumption
Title
appetite feelings
Time Frame
120 min after breakfast/drink consumption
Title
appetite feelings
Time Frame
150 min after breakfast/drink consumption
Title
appetite feelings
Time Frame
180 min after breakfast/drink consumption
Title
appetite hormones
Time Frame
fasting (-15 min)
Title
appetite hormones
Time Frame
immediately after breakfast/drink consumption (0 min)
Title
appetite hormones
Time Frame
15 min after breakfast/drink consumption
Title
appetite hormones
Time Frame
30 min after breakfast/drink consumption
Title
appetite hormones
Time Frame
60 min after breakfast/drink consumption
Title
appetite hormones
Time Frame
90 min after breakfast/drink consumption
Title
appetite hormones
Time Frame
120 min after breakfast/drink consumption
Title
appetite hormones
Time Frame
150 min after breakfast/drink consumption
Title
appetite hormones
Time Frame
180 min after breakfast/drink consumption
Title
markers of inflammation
Time Frame
fasting (-15 min)
Title
markers of inflammation
Time Frame
immediately after breakfast/drink consumption (0 min)
Title
markers of inflammation
Time Frame
15 min after breakfast/drink consumption
Title
markers of inflammation
Time Frame
30 min after breakfast/drink consumption
Title
markers of inflammation
Time Frame
60 min after breakfast/drink consumption
Title
markers of inflammation
Time Frame
90 min after breakfast/drink consumption
Title
markers of inflammation
Time Frame
120 min after breakfast/drink consumption
Title
markers of inflammation
Time Frame
150 min after breakfast/drink consumption
Title
markers of inflammation
Time Frame
180 min after breakfast/drink consumption
Title
markers of glucose metabolism
Time Frame
fasting (-15 min)
Title
markers of glucose metabolism
Time Frame
immediately after breakfast/drink consumption (0 min)
Title
markers of glucose metabolism
Time Frame
15 min after breakfast/drink consumption
Title
markers of glucose metabolism
Time Frame
30 min after breakfast/drink consumption
Title
markers of glucose metabolism
Time Frame
60 min after breakfast/drink consumption
Title
markers of glucose metabolism
Time Frame
90 min after breakfast/drink consumption
Title
markers of glucose metabolism
Time Frame
120 min after breakfast/drink consumption
Title
markers of glucose metabolism
Time Frame
150 min after breakfast/drink consumption
Title
markers of glucose metabolism
Time Frame
180 min after breakfast/drink consumption
Secondary Outcome Measure Information:
Title
% carbohydrates ad libitum
Time Frame
180 min after breakfast/drink consumption
Title
% carbohydrates total day
Time Frame
One day
Title
% protein ad libitum
Time Frame
180 min after breakfast/drink consumption
Title
% protein total day
Time Frame
One day
Title
% fat
Time Frame
180 min after breakfast/drink consumption
Title
% fat total day
Time Frame
One day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
apparently healthy
habitual coffee drinkers (>= 1cup of coffee/day)
Exclusion Criteria:
smokers
restrained eaters (as this was evaluated using the Dutch Eating Behaviour Questionnaire)
those who reported slimming or any other dietary regime
athletes
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,
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
Principal Investigator
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
background
PubMed Identifier
35961260
Citation
Perakakis N, Kokkinos A, Angelidi AM, Tsilingiris D, Gavrieli A, Yannakoulia M, Tentolouris N, Mantzoros CS. Circulating levels of five proglucagon-derived peptides in response to intravenous or oral glucose or lipids and to a mixed-meal in subjects with normal weight, overweight, and obesity. Clin Nutr. 2022 Sep;41(9):1969-1976. doi: 10.1016/j.clnu.2022.07.001. Epub 2022 Jul 19.
Results Reference
derived
PubMed Identifier
23498899
Citation
Gavrieli A, Fragopoulou E, Mantzoros CS, Yannakoulia M. Gender and body mass index modify the effect of increasing amounts of caffeinated coffee on postprandial glucose and insulin concentrations; a randomized, controlled, clinical trial. Metabolism. 2013 Aug;62(8):1099-106. doi: 10.1016/j.metabol.2013.02.003. Epub 2013 Mar 15.
Results Reference
derived
Learn more about this trial
Effects of Different Coffee Amounts on Energy Intake, Appetite, Glucose Metabolism and Inflammatory Markers
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