- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01495754
Effects of Different Coffee Amounts on Energy Intake, Appetite, Glucose Metabolism and Inflammatory Markers
19 december 2011 uppdaterad av: M. Yannakoulia, Harokopio University
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
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.
Studieöversikt
Studietyp
Interventionell
Inskrivning (Faktisk)
33
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Athens, Grekland, 17671
- Metabolic Unit of the Department of Nutrition and Dietetics, Harokopio University
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 45 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: coffee3
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Comparison of different amounts of coffee
|
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Experimentell: coffee6
|
Comparison of different amounts of coffee
|
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Placebo-jämförare: water
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Comparison of different amounts of coffee
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
energy intake ad libitum
Tidsram: 180 min after breakfast/drink consumption
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180 min after breakfast/drink consumption
|
|
total energy intake
Tidsram: One day
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One day
|
|
appetite feelings
Tidsram: fasting (-15 min)
|
fasting (-15 min)
|
|
appetite feelings
Tidsram: immediately after breakfast/drink consumption (0 min)
|
immediately after breakfast/drink consumption (0 min)
|
|
appetite feelings
Tidsram: 15 min after breakfast/drink consumption
|
15 min after breakfast/drink consumption
|
|
appetite feelings
Tidsram: 30 min after breakfast/drink consumption
|
30 min after breakfast/drink consumption
|
|
appetite feelings
Tidsram: 60 min after breakfast/drink consumption
|
60 min after breakfast/drink consumption
|
|
appetite feelings
Tidsram: 90 min after breakfast/drink consumption
|
90 min after breakfast/drink consumption
|
|
appetite feelings
Tidsram: 120 min after breakfast/drink consumption
|
120 min after breakfast/drink consumption
|
|
appetite feelings
Tidsram: 150 min after breakfast/drink consumption
|
150 min after breakfast/drink consumption
|
|
appetite feelings
Tidsram: 180 min after breakfast/drink consumption
|
180 min after breakfast/drink consumption
|
|
appetite hormones
Tidsram: fasting (-15 min)
|
fasting (-15 min)
|
|
appetite hormones
Tidsram: immediately after breakfast/drink consumption (0 min)
|
immediately after breakfast/drink consumption (0 min)
|
|
appetite hormones
Tidsram: 15 min after breakfast/drink consumption
|
15 min after breakfast/drink consumption
|
|
appetite hormones
Tidsram: 30 min after breakfast/drink consumption
|
30 min after breakfast/drink consumption
|
|
appetite hormones
Tidsram: 60 min after breakfast/drink consumption
|
60 min after breakfast/drink consumption
|
|
appetite hormones
Tidsram: 90 min after breakfast/drink consumption
|
90 min after breakfast/drink consumption
|
|
appetite hormones
Tidsram: 120 min after breakfast/drink consumption
|
120 min after breakfast/drink consumption
|
|
appetite hormones
Tidsram: 150 min after breakfast/drink consumption
|
150 min after breakfast/drink consumption
|
|
appetite hormones
Tidsram: 180 min after breakfast/drink consumption
|
180 min after breakfast/drink consumption
|
|
markers of inflammation
Tidsram: fasting (-15 min)
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fasting (-15 min)
|
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markers of inflammation
Tidsram: immediately after breakfast/drink consumption (0 min)
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immediately after breakfast/drink consumption (0 min)
|
|
markers of inflammation
Tidsram: 15 min after breakfast/drink consumption
|
15 min after breakfast/drink consumption
|
|
markers of inflammation
Tidsram: 30 min after breakfast/drink consumption
|
30 min after breakfast/drink consumption
|
|
markers of inflammation
Tidsram: 60 min after breakfast/drink consumption
|
60 min after breakfast/drink consumption
|
|
markers of inflammation
Tidsram: 90 min after breakfast/drink consumption
|
90 min after breakfast/drink consumption
|
|
markers of inflammation
Tidsram: 120 min after breakfast/drink consumption
|
120 min after breakfast/drink consumption
|
|
markers of inflammation
Tidsram: 150 min after breakfast/drink consumption
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150 min after breakfast/drink consumption
|
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markers of inflammation
Tidsram: 180 min after breakfast/drink consumption
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180 min after breakfast/drink consumption
|
|
markers of glucose metabolism
Tidsram: fasting (-15 min)
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fasting (-15 min)
|
|
markers of glucose metabolism
Tidsram: immediately after breakfast/drink consumption (0 min)
|
immediately after breakfast/drink consumption (0 min)
|
|
markers of glucose metabolism
Tidsram: 15 min after breakfast/drink consumption
|
15 min after breakfast/drink consumption
|
|
markers of glucose metabolism
Tidsram: 30 min after breakfast/drink consumption
|
30 min after breakfast/drink consumption
|
|
markers of glucose metabolism
Tidsram: 60 min after breakfast/drink consumption
|
60 min after breakfast/drink consumption
|
|
markers of glucose metabolism
Tidsram: 90 min after breakfast/drink consumption
|
90 min after breakfast/drink consumption
|
|
markers of glucose metabolism
Tidsram: 120 min after breakfast/drink consumption
|
120 min after breakfast/drink consumption
|
|
markers of glucose metabolism
Tidsram: 150 min after breakfast/drink consumption
|
150 min after breakfast/drink consumption
|
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markers of glucose metabolism
Tidsram: 180 min after breakfast/drink consumption
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180 min after breakfast/drink consumption
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Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
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% carbohydrates ad libitum
Tidsram: 180 min after breakfast/drink consumption
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180 min after breakfast/drink consumption
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% carbohydrates total day
Tidsram: One day
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One day
|
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% protein ad libitum
Tidsram: 180 min after breakfast/drink consumption
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180 min after breakfast/drink consumption
|
|
% protein total day
Tidsram: One day
|
One day
|
|
% fat
Tidsram: 180 min after breakfast/drink consumption
|
180 min after breakfast/drink consumption
|
|
% fat total day
Tidsram: One day
|
One day
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Mary Yannakoulia, PhD, Harokopio University
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
- 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.
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 januari 2011
Primärt slutförande (Faktisk)
1 juni 2011
Avslutad studie (Faktisk)
1 juni 2011
Studieregistreringsdatum
Först inskickad
16 december 2011
Först inskickad som uppfyllde QC-kriterierna
19 december 2011
Första postat (Uppskatta)
20 december 2011
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
20 december 2011
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
19 december 2011
Senast verifierad
1 december 2011
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CofSt3
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .