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Effects of Different Coffee Amounts on Energy Intake, Appetite, Glucose Metabolism and Inflammatory Markers

This study has been completed.
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Pathologic Processes

ClinicalTrials.gov processed this record on November 23, 2014