- ICH GCP
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- Essai clinique NCT01174576
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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Athens, Grèce, 17671
- Metabolic Unit of the Department of Nutrition and Dietetics, Harokopio University
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: caffeinated coffee
200 mL caffeinated coffee with 3 mg caffeine per kg body weight
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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
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Expérimental: decaffeinated coffee
200 mL decaffeinated coffee, same amount as caffeinated coffee
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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
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Expérimental: Water
200 mL, control intervention
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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
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Ghrelin Total Area Under the Curve
Délai: 15 min before ingestion to 3 hr post ingestion
|
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.
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15 min before ingestion to 3 hr post ingestion
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Peptide Tyrosine Tyrosine (PYY) Total Area Under the Curve
Délai: 15 min before ingestion to 3 hr post ingestion
|
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.
|
15 min before ingestion to 3 hr post ingestion
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Glucagon-like Peptide-1 (GLP-1) Total Area Under the Curve
Délai: 15 min before ingestion to 3 hr post ingestion
|
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.
|
15 min before ingestion to 3 hr post ingestion
|
Adiponectin Total Area Under the Curve
Délai: 15 min before ingestion to 3 h post ingestion
|
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.
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15 min before ingestion to 3 h post ingestion
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Inteleukin-6 Total Area Under the Curve
Délai: 15 min before ingestion to 3 hr post ingestion
|
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.
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15 min before ingestion to 3 hr post ingestion
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Interleukin-18 Total Area Under the Curve
Délai: 15 min before ingestion to 3 hr post ingestion
|
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.
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15 min before ingestion to 3 hr post ingestion
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Glucose Total Area Under the Curve
Délai: 15 min before ingestion to 3 hr post ingestion
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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.
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15 min before ingestion to 3 hr post ingestion
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Insulin Total Area Under the Curve
Délai: 15 min before ingestion to 3 hr post ingestion
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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.
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15 min before ingestion to 3 hr post ingestion
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Cortisol Total Area Under the Curve
Délai: 15 min before ingestion to 3 hr post ingestion
|
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.
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15 min before ingestion to 3 hr post ingestion
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Energy ad Libitum Meal
Délai: 3 hr post ingestion
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The energy of first meal 3 hr after ingestion
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3 hr post ingestion
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Total Energy Intake
Délai: 1 d
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the energy consumed at breakfast, ad libitum meal and rest of the experimental day
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1 d
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Serum Antioxidant Capacity Total Area Under the Curve
Délai: 15 min before ingestion to 21/2 hr post ingestion
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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. |
15 min before ingestion to 21/2 hr post ingestion
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Directeur d'études: Mary Yannakoulia, PhD, Harokopio University
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CofSt
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