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Completed

NCT Number: NCT00523861

Moderate Alcohol Consumption, Glucose Metabolism and Gastric Emptying

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

TNO Quality of Life

Zeist, Utrecht, 3700AJ, Netherlands

About this study

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)

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

moderate alcohol consumption

Dietary Supplement

Primary outcomes

  1. 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

Secondary outcomes

  1. Secondly, the effect of moderate alcohol consumption on gastric emptying and postprandial wellness will be studied.

    Time frame: 3 weeks

Sponsors and collaborators

Lead sponsor

TNO

Other

Registry information

Official study title

The Effect of Moderate Alcohol Consumption on Glucose Metabolism and Gastric Emptying in Healthy, Lean and Overweight Young Men

Important dates

Study start
2005
Study completion
2005
First posted
Sep 3, 2007
Registry last updated
Sep 14, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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