- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01495754
Effects of Different Coffee Amounts on Energy Intake, Appetite, Glucose Metabolism and Inflammatory Markers
19. desember 2011 oppdatert 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.
Studieoversikt
Studietype
Intervensjonell
Registrering (Faktiske)
33
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Athens, Hellas, 17671
- Metabolic Unit of the Department of Nutrition and Dietetics, Harokopio University
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 45 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: coffee3
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Comparison of different amounts of coffee
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Eksperimentell: coffee6
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Comparison of different amounts of coffee
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Placebo komparator: water
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Comparison of different amounts of coffee
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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energy intake ad libitum
Tidsramme: 180 min after breakfast/drink consumption
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180 min after breakfast/drink consumption
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total energy intake
Tidsramme: One day
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One day
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appetite feelings
Tidsramme: fasting (-15 min)
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fasting (-15 min)
|
|
appetite feelings
Tidsramme: immediately after breakfast/drink consumption (0 min)
|
immediately after breakfast/drink consumption (0 min)
|
|
appetite feelings
Tidsramme: 15 min after breakfast/drink consumption
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15 min after breakfast/drink consumption
|
|
appetite feelings
Tidsramme: 30 min after breakfast/drink consumption
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30 min after breakfast/drink consumption
|
|
appetite feelings
Tidsramme: 60 min after breakfast/drink consumption
|
60 min after breakfast/drink consumption
|
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appetite feelings
Tidsramme: 90 min after breakfast/drink consumption
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90 min after breakfast/drink consumption
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appetite feelings
Tidsramme: 120 min after breakfast/drink consumption
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120 min after breakfast/drink consumption
|
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appetite feelings
Tidsramme: 150 min after breakfast/drink consumption
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150 min after breakfast/drink consumption
|
|
appetite feelings
Tidsramme: 180 min after breakfast/drink consumption
|
180 min after breakfast/drink consumption
|
|
appetite hormones
Tidsramme: fasting (-15 min)
|
fasting (-15 min)
|
|
appetite hormones
Tidsramme: immediately after breakfast/drink consumption (0 min)
|
immediately after breakfast/drink consumption (0 min)
|
|
appetite hormones
Tidsramme: 15 min after breakfast/drink consumption
|
15 min after breakfast/drink consumption
|
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appetite hormones
Tidsramme: 30 min after breakfast/drink consumption
|
30 min after breakfast/drink consumption
|
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appetite hormones
Tidsramme: 60 min after breakfast/drink consumption
|
60 min after breakfast/drink consumption
|
|
appetite hormones
Tidsramme: 90 min after breakfast/drink consumption
|
90 min after breakfast/drink consumption
|
|
appetite hormones
Tidsramme: 120 min after breakfast/drink consumption
|
120 min after breakfast/drink consumption
|
|
appetite hormones
Tidsramme: 150 min after breakfast/drink consumption
|
150 min after breakfast/drink consumption
|
|
appetite hormones
Tidsramme: 180 min after breakfast/drink consumption
|
180 min after breakfast/drink consumption
|
|
markers of inflammation
Tidsramme: fasting (-15 min)
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fasting (-15 min)
|
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markers of inflammation
Tidsramme: immediately after breakfast/drink consumption (0 min)
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immediately after breakfast/drink consumption (0 min)
|
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markers of inflammation
Tidsramme: 15 min after breakfast/drink consumption
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15 min after breakfast/drink consumption
|
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markers of inflammation
Tidsramme: 30 min after breakfast/drink consumption
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30 min after breakfast/drink consumption
|
|
markers of inflammation
Tidsramme: 60 min after breakfast/drink consumption
|
60 min after breakfast/drink consumption
|
|
markers of inflammation
Tidsramme: 90 min after breakfast/drink consumption
|
90 min after breakfast/drink consumption
|
|
markers of inflammation
Tidsramme: 120 min after breakfast/drink consumption
|
120 min after breakfast/drink consumption
|
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markers of inflammation
Tidsramme: 150 min after breakfast/drink consumption
|
150 min after breakfast/drink consumption
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markers of inflammation
Tidsramme: 180 min after breakfast/drink consumption
|
180 min after breakfast/drink consumption
|
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markers of glucose metabolism
Tidsramme: fasting (-15 min)
|
fasting (-15 min)
|
|
markers of glucose metabolism
Tidsramme: immediately after breakfast/drink consumption (0 min)
|
immediately after breakfast/drink consumption (0 min)
|
|
markers of glucose metabolism
Tidsramme: 15 min after breakfast/drink consumption
|
15 min after breakfast/drink consumption
|
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markers of glucose metabolism
Tidsramme: 30 min after breakfast/drink consumption
|
30 min after breakfast/drink consumption
|
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markers of glucose metabolism
Tidsramme: 60 min after breakfast/drink consumption
|
60 min after breakfast/drink consumption
|
|
markers of glucose metabolism
Tidsramme: 90 min after breakfast/drink consumption
|
90 min after breakfast/drink consumption
|
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markers of glucose metabolism
Tidsramme: 120 min after breakfast/drink consumption
|
120 min after breakfast/drink consumption
|
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markers of glucose metabolism
Tidsramme: 150 min after breakfast/drink consumption
|
150 min after breakfast/drink consumption
|
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markers of glucose metabolism
Tidsramme: 180 min after breakfast/drink consumption
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180 min after breakfast/drink consumption
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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% carbohydrates ad libitum
Tidsramme: 180 min after breakfast/drink consumption
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180 min after breakfast/drink consumption
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% carbohydrates total day
Tidsramme: One day
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One day
|
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% protein ad libitum
Tidsramme: 180 min after breakfast/drink consumption
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180 min after breakfast/drink consumption
|
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% protein total day
Tidsramme: One day
|
One day
|
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% fat
Tidsramme: 180 min after breakfast/drink consumption
|
180 min after breakfast/drink consumption
|
|
% fat total day
Tidsramme: One day
|
One day
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Mary Yannakoulia, PhD, Harokopio University
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. januar 2011
Primær fullføring (Faktiske)
1. juni 2011
Studiet fullført (Faktiske)
1. juni 2011
Datoer for studieregistrering
Først innsendt
16. desember 2011
Først innsendt som oppfylte QC-kriteriene
19. desember 2011
Først lagt ut (Anslag)
20. desember 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
20. desember 2011
Siste oppdatering sendt inn som oppfylte QC-kriteriene
19. desember 2011
Sist bekreftet
1. desember 2011
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CofSt3
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .