Acute Effects of Coffee on Appetite and Inflammation Markers, Glucose Metabolism and Energy Intake

This study has been completed.
Sponsor:
Collaborator:
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
M. Yannakoulia, Harokopio University
ClinicalTrials.gov Identifier:
NCT01174576
First received: July 26, 2010
Last updated: July 26, 2013
Last verified: July 2013

July 26, 2010
July 26, 2013
February 2009
May 2009   (final data collection date for primary outcome measure)
  • Ghrelin Total Area Under the Curve [ Time Frame: 15 min before ingestion to 3 hr post ingestion ] [ Designated as safety issue: No ]
    Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.
  • Peptide Tyrosine Tyrosine (PYY) Total Area Under the Curve [ Time Frame: 15 min before ingestion to 3 hr post ingestion ] [ Designated as safety issue: No ]
    Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.
  • Glucagon-like Peptide-1 (GLP-1) Total Area Under the Curve [ Time Frame: 15 min before ingestion to 3 hr post ingestion ] [ Designated as safety issue: No ]
    Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.
  • Adiponectin Total Area Under the Curve [ Time Frame: 15 min before ingestion to 3 h post ingestion ] [ Designated as safety issue: No ]
    Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.
  • Inteleukin-6 Total Area Under the Curve [ Time Frame: 15 min before ingestion to 3 hr post ingestion ] [ Designated as safety issue: No ]
    Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.
  • Interleukin-18 Total Area Under the Curve [ Time Frame: 15 min before ingestion to 3 hr post ingestion ] [ Designated as safety issue: No ]
    Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.
  • Glucose Total Area Under the Curve [ Time Frame: 15 min before ingestion to 3 hr post ingestion ] [ Designated as safety issue: No ]
    Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.
  • Insulin Total Area Under the Curve [ Time Frame: 15 min before ingestion to 3 hr post ingestion ] [ Designated as safety issue: No ]
    Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.
  • Cortisol Total Area Under the Curve [ Time Frame: 15 min before ingestion to 3 hr post ingestion ] [ Designated as safety issue: No ]
    Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.
  • Energy ad Libitum Meal [ Time Frame: 3 hr post ingestion ] [ Designated as safety issue: No ]
    The energy of first meal 3 hr after ingestion
  • Total Energy Intake [ Time Frame: 1 d ] [ Designated as safety issue: No ]
    the energy consumed at breakfast, ad libitum meal and rest of the experimental day
  • markers of appetite [ Time Frame: fasting (-15 min) ] [ Designated as safety issue: No ]
  • energy intake [ Time Frame: ad libitum meal (180 min after breakfast consumption) ] [ Designated as safety issue: No ]
  • markers of appetite [ Time Frame: immediately after breakfast consumption (0 min) ] [ Designated as safety issue: No ]
  • markers of appetite [ Time Frame: 15 min after breakfast consumption ] [ Designated as safety issue: No ]
  • markers of appetite [ Time Frame: 30 min after breakfast consumption ] [ Designated as safety issue: No ]
  • markers of appetite [ Time Frame: 60 min after breakfast consumption ] [ Designated as safety issue: No ]
  • markers of appetite [ Time Frame: 90 min after breakfast consumption ] [ Designated as safety issue: No ]
  • markers of appetite [ Time Frame: 120 min after breakfast consumption ] [ Designated as safety issue: No ]
  • markers of appetite [ Time Frame: 150 min after breakfast consumption ] [ Designated as safety issue: No ]
  • markers of appetite [ Time Frame: 180 min after breakfast consumption ] [ Designated as safety issue: No ]
  • markers of inflammation [ Time Frame: fasting (-15 min) ] [ Designated as safety issue: No ]
  • markers of inflammation [ Time Frame: 30 min after breakfast consumption ] [ Designated as safety issue: No ]
  • markers of inflammation [ Time Frame: 60 min after breakfast consumption ] [ Designated as safety issue: No ]
  • markers of inflammation [ Time Frame: 90 min after breakfast consumption ] [ Designated as safety issue: No ]
  • markers of inflammation [ Time Frame: 120 min after breakfast consumption ] [ Designated as safety issue: No ]
  • markers of inflammation [ Time Frame: 150 min after breakfast consumption ] [ Designated as safety issue: No ]
  • markers of inflammation [ Time Frame: 180 min after breakfast 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 consumption (0 min) ] [ Designated as safety issue: No ]
  • markers of glucose metabolism [ Time Frame: 15 min after breakfast consumption ] [ Designated as safety issue: No ]
  • markers of glucose metabolism [ Time Frame: 30 min after breakfast consumption ] [ Designated as safety issue: No ]
  • markers of glucose metabolism [ Time Frame: 60 min after breakfast consumption ] [ Designated as safety issue: No ]
  • markers of glucose metabolism [ Time Frame: 90 min after breakfast consumption ] [ Designated as safety issue: No ]
  • markers of glucose metabolism [ Time Frame: 120 min after breakfast consumption ] [ Designated as safety issue: No ]
  • markers of glucose metabolism [ Time Frame: 150 min after breakfast consumption ] [ Designated as safety issue: No ]
  • markers of glucose metabolism [ Time Frame: 180 min after breakfast consumption ] [ Designated as safety issue: No ]
  • energy intake [ Time Frame: rest of the day (total day after the 4h experiment) ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01174576 on ClinicalTrials.gov Archive Site
Serum Antioxidant Capacity Total Area Under the Curve [ Time Frame: 15 min before ingestion to 21/2 hr post ingestion ] [ Designated as safety issue: No ]

Serum samples, collected 15 min before ingestion, immediately after ingestion, 15 min, 30 min, 60 min, 90 min, 120 min and 150 min after ingestion were analyzed for the ex vivo serum resistance to oxidative stress, that was induced by copper sulfate (CuSO4). The analysis of all collected samples was performed by the measurement of conjugated diene formation, which was monitored for every sample of all time points every 2 min for a 3.5 h period at 234 nm in a microplate spectrophotometer.

Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150 min postconsumption.

  • macronutrient intake [ Time Frame: ad libitum meal (180 min after breakfast consumption) ] [ Designated as safety issue: No ]
  • macronutrient intake [ Time Frame: rest of the day (total day after the 4h experiment) ] [ Designated as safety issue: No ]
  • oxidative status [ Time Frame: fasting (-15 min) ] [ Designated as safety issue: No ]
  • oxidative status [ Time Frame: immediately after breakfast consumption (0 min) ] [ Designated as safety issue: No ]
  • oxidative status [ Time Frame: 15 min after breakfast consumption ] [ Designated as safety issue: No ]
  • oxidative status [ Time Frame: 30 min after breakfast consumption ] [ Designated as safety issue: No ]
  • oxidative status [ Time Frame: 60 min after breakfast consumption ] [ Designated as safety issue: No ]
  • oxidative status [ Time Frame: 90 min after breakfast consumption ] [ Designated as safety issue: No ]
  • oxidative status [ Time Frame: 120 min after breakfast consumption ] [ Designated as safety issue: No ]
  • oxidative status [ Time Frame: 150 min after breakfast consumption ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Acute Effects of Coffee on Appetite and Inflammation Markers, Glucose Metabolism and Energy Intake
Acute Effects of Caffeinated and Decaffeinated Coffee Consumption on Energy Intake, Appetite, Inflammation and Glucose Metabolism

The purpose of the study is to investigate whether caffeinated and decaffeinated 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.

Coffee is a pharmacologically active, widely consumed beverage. Scientific interest in relation to coffee consumption has been revisited the last decade in the light of new, mainly epidemiological, evidence indicating its potential health benefits. In specific, both cross-sectional and prospective studies indicate that coffee consumption is associated with a lower risk for type 2 diabetes. Furthermore, an inverse association has been found between coffee consumption and markers of inflammation and endothelial dysfunction in healthy and/or diabetic participants, although the opposite effect has also been reported, mainly in relation to inflammation markers. In relation to body weight, epidemiological data suggest that increment in caffeine consumption is associated with lower mean weight gain and energy intake during a 12-y period.

However, information from clinical studies is scarce. Acute caffeine and/or coffee consumption have been associated with impaired glucose metabolism and insulin resistance. In relation to inflammation, animal studies have indicated a beneficial or no effect of coffee consumption, whereas a clinical study in humans found an increase in adiponectin and a decrease in interleukin-18 (IL-18) blood concentrations after a monthly intervention including daily consumption of 8 cups of coffee. As far as energy balance is concerned, there is an early experiment demonstrating that the ingestion of 300 mg of caffeine prior to food intake, compared to the non-caffeine intake, significantly reduced energy intake by 21.7% in men, but not in women. A more recent study has found that the combination of caffeine and red pepper is positively associated with energy expenditure and negatively with energy intake, whereas, it has also been reported a positive association between habitual caffeine intake and body weight loss achieved through a very-low-calorie diet.

Taking into consideration the limited clinical evidence regarding the acute effect of coffee consumption on appetite-related markers, subsequent energy intake and inflammatory markers, we undertook a clinical study of crossover design to investigate the short-term changes on energy intake, subjective appetite ratings, appetite hormones, inflammation markers and glucose metabolism after caffeinated and decaffeinated coffee consumption.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Health
Other: caffeinated and decaffeinated coffee
3 treatments on separate days, i.e. a standard breakfast with oral ingestion of 200 ml of either caffeinated coffee (3mg caffeine/kg body weight), decaffeinated coffee or water
  • Experimental: caffeinated coffee
    200 mL caffeinated coffee with 3 mg caffeine per kg body weight
    Intervention: Other: caffeinated and decaffeinated coffee
  • Experimental: decaffeinated coffee
    200 mL decaffeinated coffee, same amount as caffeinated coffee
    Intervention: Other: caffeinated and decaffeinated coffee
  • Experimental: Water
    200 mL, control intervention
    Intervention: Other: caffeinated and decaffeinated coffee
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
May 2009
May 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • healthy
  • non-obese

Exclusion Criteria:

  • smokers
  • restrained eaters (as this was evaluated using the Dutch Eating Behaviour Questionnaire and a total score > 2.5)
  • those who reported slimming or any other dietary regime
  • abstainers from caffeine sources
  • athletes during competition period
  • 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, or a history of medical or surgical events that may have affected the study outcomes
Male
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Greece
 
NCT01174576
CofSt
No
M. Yannakoulia, Harokopio University
Harokopio University
Beth Israel Deaconess Medical Center
Study Director: Mary Yannakoulia, PhD Harokopio University
Harokopio University
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP