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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01495754
Other study ID # CofSt3
Secondary ID
Status Completed
Phase N/A
First received December 16, 2011
Last updated December 19, 2011
Start date January 2011
Est. completion date June 2011

Study information

Verified date December 2011
Source Harokopio University
Contact n/a
Is FDA regulated No
Health authority Greece: Ethics Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 33
Est. completion date June 2011
Est. primary completion date June 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 45 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
coffee
Comparison of different amounts of coffee

Locations

Country Name City State
Greece Metabolic Unit of the Department of Nutrition and Dietetics, Harokopio University Athens

Sponsors (1)

Lead Sponsor Collaborator
Harokopio University

Country where clinical trial is conducted

Greece, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary energy intake ad libitum 180 min after breakfast/drink consumption No
Primary total energy intake One day No
Primary appetite feelings fasting (-15 min) No
Primary appetite feelings immediately after breakfast/drink consumption (0 min) No
Primary appetite feelings 15 min after breakfast/drink consumption No
Primary appetite feelings 30 min after breakfast/drink consumption No
Primary appetite feelings 60 min after breakfast/drink consumption No
Primary appetite feelings 90 min after breakfast/drink consumption No
Primary appetite feelings 120 min after breakfast/drink consumption No
Primary appetite feelings 150 min after breakfast/drink consumption No
Primary appetite feelings 180 min after breakfast/drink consumption No
Primary appetite hormones fasting (-15 min) No
Primary appetite hormones immediately after breakfast/drink consumption (0 min) No
Primary appetite hormones 15 min after breakfast/drink consumption No
Primary appetite hormones 30 min after breakfast/drink consumption No
Primary appetite hormones 60 min after breakfast/drink consumption No
Primary appetite hormones 90 min after breakfast/drink consumption No
Primary appetite hormones 120 min after breakfast/drink consumption No
Primary appetite hormones 150 min after breakfast/drink consumption No
Primary appetite hormones 180 min after breakfast/drink consumption No
Primary markers of inflammation fasting (-15 min) No
Primary markers of inflammation immediately after breakfast/drink consumption (0 min) No
Primary markers of inflammation 15 min after breakfast/drink consumption No
Primary markers of inflammation 30 min after breakfast/drink consumption No
Primary markers of inflammation 60 min after breakfast/drink consumption No
Primary markers of inflammation 90 min after breakfast/drink consumption No
Primary markers of inflammation 120 min after breakfast/drink consumption No
Primary markers of inflammation 150 min after breakfast/drink consumption No
Primary markers of inflammation 180 min after breakfast/drink consumption No
Primary markers of glucose metabolism fasting (-15 min) No
Primary markers of glucose metabolism immediately after breakfast/drink consumption (0 min) No
Primary markers of glucose metabolism 15 min after breakfast/drink consumption No
Primary markers of glucose metabolism 30 min after breakfast/drink consumption No
Primary markers of glucose metabolism 60 min after breakfast/drink consumption No
Primary markers of glucose metabolism 90 min after breakfast/drink consumption No
Primary markers of glucose metabolism 120 min after breakfast/drink consumption No
Primary markers of glucose metabolism 150 min after breakfast/drink consumption No
Primary markers of glucose metabolism 180 min after breakfast/drink consumption No
Secondary % carbohydrates ad libitum 180 min after breakfast/drink consumption No
Secondary % carbohydrates total day One day No
Secondary % protein ad libitum 180 min after breakfast/drink consumption No
Secondary % protein total day One day No
Secondary % fat 180 min after breakfast/drink consumption No
Secondary % fat total day One day No
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