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Moderate Alcohol Consumption, Glucose Metabolism and Gastric Emptying

This study has been completed.
Sponsor:
Information provided by:
TNO
ClinicalTrials.gov Identifier:
NCT00523861
First received: August 30, 2007
Last updated: September 10, 2007
Last verified: August 2007

August 30, 2007
September 10, 2007
May 2005
Not Provided
The primary objective of this study is to investigate the effect of moderate daily alcohol consumption on hepatic glucose uptake and peripheral glucose storage [ Time Frame: 3 weeks ]
Same as current
Complete list of historical versions of study NCT00523861 on ClinicalTrials.gov Archive Site
Secondly, the effect of moderate alcohol consumption on gastric emptying and postprandial wellness will be studied. [ Time Frame: 3 weeks ]
Same as current
Not Provided
Not Provided
 
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

Moderate alcohol consumption is associated with a decreased risk of type II diabetes mellitus. In a recent study of Greenfield et al. it was observed that moderate alcohol consumption significantly improved postprandial glucose concentrations. Similar observations were made in our previous study. One of the mechanisms by which this may occur is delayed gastric emptying after alcohol consumption.

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)
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
  • Lean
  • Obese
Dietary Supplement: Moderate alcohol consumption
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
June 2005
Not Provided

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
Male
18 Years to 40 Years
Not Provided
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00523861
P6281, Alcohol Research 19
Not Provided
Not Provided
TNO
Not Provided
Principal Investigator: Henk FJ Hendriks, PhD Hendriks HFJ
TNO
August 2007

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