Effects of Different Coffee Amounts on Energy Intake, Appetite, Glucose Metabolism and Inflammatory Markers
This study has been completed.
Sponsor:
Harokopio University
Information provided by (Responsible Party):
M. Yannakoulia, Harokopio University
ClinicalTrials.gov Identifier:
NCT01495754
First received: December 16, 2011
Last updated: December 19, 2011
Last verified: December 2011
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Obesity Inflammation |
Other: coffee |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Harokopio University:
Primary Outcome Measures:
- energy intake ad libitum [ Time Frame: 180 min after breakfast/drink consumption ] [ Designated as safety issue: No ]
- total energy intake [ Time Frame: One day ] [ Designated as safety issue: No ]
- appetite feelings [ Time Frame: fasting (-15 min) ] [ Designated as safety issue: No ]
- appetite feelings [ Time Frame: immediately after breakfast/drink consumption (0 min) ] [ Designated as safety issue: No ]
- appetite feelings [ Time Frame: 15 min after breakfast/drink consumption ] [ Designated as safety issue: No ]
- appetite feelings [ Time Frame: 30 min after breakfast/drink consumption ] [ Designated as safety issue: No ]
- appetite feelings [ Time Frame: 60 min after breakfast/drink consumption ] [ Designated as safety issue: No ]
- appetite feelings [ Time Frame: 90 min after breakfast/drink consumption ] [ Designated as safety issue: No ]
- appetite feelings [ Time Frame: 120 min after breakfast/drink consumption ] [ Designated as safety issue: No ]
- appetite feelings [ Time Frame: 150 min after breakfast/drink consumption ] [ Designated as safety issue: No ]
- appetite feelings [ Time Frame: 180 min after breakfast/drink consumption ] [ Designated as safety issue: No ]
- appetite hormones [ Time Frame: fasting (-15 min) ] [ Designated as safety issue: No ]
- appetite hormones [ Time Frame: immediately after breakfast/drink consumption (0 min) ] [ Designated as safety issue: No ]
- appetite hormones [ Time Frame: 15 min after breakfast/drink consumption ] [ Designated as safety issue: No ]
- appetite hormones [ Time Frame: 30 min after breakfast/drink consumption ] [ Designated as safety issue: No ]
- appetite hormones [ Time Frame: 60 min after breakfast/drink consumption ] [ Designated as safety issue: No ]
- appetite hormones [ Time Frame: 90 min after breakfast/drink consumption ] [ Designated as safety issue: No ]
- appetite hormones [ Time Frame: 120 min after breakfast/drink consumption ] [ Designated as safety issue: No ]
- appetite hormones [ Time Frame: 150 min after breakfast/drink consumption ] [ Designated as safety issue: No ]
- appetite hormones [ Time Frame: 180 min after breakfast/drink consumption ] [ Designated as safety issue: No ]
- markers of inflammation [ Time Frame: fasting (-15 min) ] [ Designated as safety issue: No ]
- markers of inflammation [ Time Frame: immediately after breakfast/drink consumption (0 min) ] [ Designated as safety issue: No ]
- markers of inflammation [ Time Frame: 15 min after breakfast/drink consumption ] [ Designated as safety issue: No ]
- markers of inflammation [ Time Frame: 30 min after breakfast/drink consumption ] [ Designated as safety issue: No ]
- markers of inflammation [ Time Frame: 60 min after breakfast/drink consumption ] [ Designated as safety issue: No ]
- markers of inflammation [ Time Frame: 90 min after breakfast/drink consumption ] [ Designated as safety issue: No ]
- markers of inflammation [ Time Frame: 120 min after breakfast/drink consumption ] [ Designated as safety issue: No ]
- markers of inflammation [ Time Frame: 150 min after breakfast/drink consumption ] [ Designated as safety issue: No ]
- markers of inflammation [ Time Frame: 180 min after breakfast/drink consumption ] [ Designated as safety issue: No ]
- markers of glucose metabolism [ Time Frame: fasting (-15 min) ] [ Designated as safety issue: No ]
- markers of glucose metabolism [ Time Frame: immediately after breakfast/drink consumption (0 min) ] [ Designated as safety issue: No ]
- markers of glucose metabolism [ Time Frame: 15 min after breakfast/drink consumption ] [ Designated as safety issue: No ]
- markers of glucose metabolism [ Time Frame: 30 min after breakfast/drink consumption ] [ Designated as safety issue: No ]
- markers of glucose metabolism [ Time Frame: 60 min after breakfast/drink consumption ] [ Designated as safety issue: No ]
- markers of glucose metabolism [ Time Frame: 90 min after breakfast/drink consumption ] [ Designated as safety issue: No ]
- markers of glucose metabolism [ Time Frame: 120 min after breakfast/drink consumption ] [ Designated as safety issue: No ]
- markers of glucose metabolism [ Time Frame: 150 min after breakfast/drink consumption ] [ Designated as safety issue: No ]
- markers of glucose metabolism [ Time Frame: 180 min after breakfast/drink consumption ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- % carbohydrates ad libitum [ Time Frame: 180 min after breakfast/drink consumption ] [ Designated as safety issue: No ]
- % carbohydrates total day [ Time Frame: One day ] [ Designated as safety issue: No ]
- % protein ad libitum [ Time Frame: 180 min after breakfast/drink consumption ] [ Designated as safety issue: No ]
- % protein total day [ Time Frame: One day ] [ Designated as safety issue: No ]
- % fat [ Time Frame: 180 min after breakfast/drink consumption ] [ Designated as safety issue: No ]
- % fat total day [ Time Frame: One day ] [ Designated as safety issue: No ]
| Enrollment: | 33 |
| Study Start Date: | January 2011 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: coffee3 |
Other: coffee
Comparison of different amounts of coffee
|
| Experimental: coffee6 |
Other: coffee
Comparison of different amounts of coffee
|
| Placebo Comparator: water |
Other: coffee
Comparison of different amounts of coffee
|
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01495754
Locations
| Greece | |
| Metabolic Unit of the Department of Nutrition and Dietetics, Harokopio University | |
| Athens, Greece, 17671 | |
Sponsors and Collaborators
Harokopio University
Investigators
| Principal Investigator: | Mary Yannakoulia, PhD | Harokopio University |
More Information
Publications:
| Responsible Party: | M. Yannakoulia, Assistant Professor, Harokopio University |
| ClinicalTrials.gov Identifier: | NCT01495754 History of Changes |
| Other Study ID Numbers: | CofSt3 |
| Study First Received: | December 16, 2011 |
| Last Updated: | December 19, 2011 |
| Health Authority: | Greece: Ethics Committee |
Keywords provided by Harokopio University:
|
coffee overweight/obese appetite energy intake |
inflammation glucose metabolism randomized controlled trial |
Additional relevant MeSH terms:
|
Inflammation Obesity Pathologic Processes Overnutrition |
Nutrition Disorders Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013