Clinical trial NCT01495754: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Inflammation
Keywords: coffee
overweight/obese
appetite
energy intake
inflammation
glucose metabolism
randomized controlled trial
Lead sponsor: Harokopio University
Sponsor class: OTHER
First posted: 2011-12-20
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: energy intake ad libitum
timeFrame: 180 min after breakfast/drink consumption
measure: total energy intake
timeFrame: One day
measure: appetite feelings
timeFrame: fasting (-15 min)
measure: appetite feelings
timeFrame: immediately after breakfast/drink consumption (0 min)
measure: appetite feelings
timeFrame: 15 min after breakfast/drink consumption
measure: appetite feelings
timeFrame: 30 min after breakfast/drink consumption
measure: appetite feelings
timeFrame: 60 min after breakfast/drink consumption
measure: appetite feelings
timeFrame: 90 min after breakfast/drink consumption
measure: appetite feelings
timeFrame: 120 min after breakfast/drink consumption
measure: appetite feelings
timeFrame: 150 min after breakfast/drink consumption
measure: appetite feelings
timeFrame: 180 min after breakfast/drink consumption
measure: appetite hormones
timeFrame: fasting (-15 min)
measure: appetite hormones
timeFrame: immediately after breakfast/drink consumption (0 min)
measure: appetite hormones
timeFrame: 15 min after breakfast/drink consumption
measure: appetite hormones
timeFrame: 30 min after breakfast/drink consumption
measure: appetite hormones
timeFrame: 60 min after breakfast/drink consumption
measure: appetite hormones
timeFrame: 90 min after breakfast/drink consumption
measure: appetite hormones
timeFrame: 120 min after breakfast/drink consumption
measure: appetite hormones
timeFrame: 150 min after breakfast/drink consumption
measure: appetite hormones
timeFrame: 180 min after breakfast/drink consumption
measure: markers of inflammation
timeFrame: fasting (-15 min)
measure: markers of inflammation
timeFrame: immediately after breakfast/drink consumption (0 min)
measure: markers of inflammation
timeFrame: 15 min after breakfast/drink consumption
measure: markers of inflammation
timeFrame: 30 min after breakfast/drink consumption
measure: markers of inflammation
timeFrame: 60 min after breakfast/drink consumption
measure: markers of inflammation
timeFrame: 90 min after breakfast/drink consumption
measure: markers of inflammation
timeFrame: 120 min after breakfast/drink consumption
measure: markers of inflammation
timeFrame: 150 min after breakfast/drink consumption
measure: markers of inflammation
timeFrame: 180 min after breakfast/drink consumption
measure: markers of glucose metabolism
timeFrame: fasting (-15 min)
measure: markers of glucose metabolism
timeFrame: immediately after breakfast/drink consumption (0 min)
measure: markers of glucose metabolism
timeFrame: 15 min after breakfast/drink consumption
measure: markers of glucose metabolism
timeFrame: 30 min after breakfast/drink consumption
measure: markers of glucose metabolism
timeFrame: 60 min after breakfast/drink consumption
measure: markers of glucose metabolism
timeFrame: 90 min after breakfast/drink consumption
measure: markers of glucose metabolism
timeFrame: 120 min after breakfast/drink consumption
measure: markers of glucose metabolism
timeFrame: 150 min after breakfast/drink consumption
measure: markers of glucose metabolism
timeFrame: 180 min after breakfast/drink consumption
Secondary outcomes:
measure: % carbohydrates ad libitum
timeFrame: 180 min after breakfast/drink consumption
measure: % carbohydrates total day
timeFrame: One day
measure: % protein ad libitum
timeFrame: 180 min after breakfast/drink consumption
measure: % protein total day
timeFrame: One day
measure: % fat
timeFrame: 180 min after breakfast/drink consumption
measure: % fat total day
timeFrame: One day
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Metabolic Unit of the Department of Nutrition and Dietetics, Harokopio University
Study officials:
affiliation: Harokopio University
name: Mary Yannakoulia, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.