- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00523861
Moderate Alcohol Consumption, Glucose Metabolism and Gastric Emptying
The Effect of Moderate Alcohol Consumption on Glucose Metabolism and Gastric Emptying in Healthy, Lean and Overweight Young Men
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Purpose: The primary objective of this study is to investigate the effect of moderate daily alcohol consumption on hepatic glucose uptake and peripheral glucose storage. Secondly, the effect of moderate alcohol consumption on gastric emptying and postprandial wellness will be studied. These effects will be studied in apparently healthy, lean or overweight young men.
Design: Randomized, partially diet-controlled, placebo controlled cross-over design.
Subjects: Healthy male lean and obese volunteers aged between 18 and 40 years (n=18).
Intervention: During 2 periods of 21 days either white wine or white grape juice has to be consumed with the evening meal. The last 7 days of each period will be fully dietary controlled.
Treatment A: 375 ml of white wine (35 g alcohol) per day Treatment B: 375 ml of white grape juice per day
Measures:
- Glucose metabolism: glucose uptake and peripheral glucose storage (measurement of isotopic enriched plasma glucose levels.
- Gastric emptying and postprandial wellness.
- Postprandial glycemic response and related factors (glucose, insulin, lactate, FFA, glucagon, ghrelin, CCK, GIP, GLP-1, PYY, triglycerides, total cholesterol, HDL cholesterol, LDL cholesterol, paracetamol (absorption test)
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Utrecht
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Zeist, Utrecht, Holland, 3700AJ
- TNO Quality of Life
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Healthy as assessed by the:
- physical examination
- results of the pre-study laboratory tests
- Males aged between 18 and 40 years at Day 01 of the study (including 18 and 40)
- Lean subjects and overweight/obese subjects: BMI 18.5-35 kg/m2
- Alcohol consumption between 7 and 28 units/week (including 7 and 28)
- Non restrained eater, defined as a score ≤ 2.5 on the Dutch Restrained Eating Questionnaire
Exclusion Criteria:
- Smoking
- Not willing or able to change habitual alcohol consumption during the study according to protocol
- Having an allergy for paracetamol
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
The primary objective of this study is to investigate the effect of moderate daily alcohol consumption on hepatic glucose uptake and peripheral glucose storage
Tidsramme: 3 weeks
|
3 weeks
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Secondly, the effect of moderate alcohol consumption on gastric emptying and postprandial wellness will be studied.
Tidsramme: 3 weeks
|
3 weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Henk FJ Hendriks, PhD, Hendriks HFJ
Datoer for undersøgelser
Studer store datoer
Studiestart
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- P6281
- Alcohol Research 19
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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