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
  Purpose

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.


Condition Intervention
Lean
Obese
Dietary Supplement: Moderate alcohol consumption

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: The Effect of Moderate Alcohol Consumption on Glucose Metabolism and Gastric Emptying in Healthy, Lean and Overweight Young Men

Resource links provided by NLM:


Further study details as provided by TNO:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Secondly, the effect of moderate alcohol consumption on gastric emptying and postprandial wellness will be studied. [ Time Frame: 3 weeks ]

Enrollment: 17
Study Start Date: May 2005
Study Completion Date: June 2005
Detailed Description:

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)
  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Male
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00523861

Locations
Netherlands
TNO Quality of Life
Zeist, Utrecht, Netherlands, 3700AJ
Sponsors and Collaborators
TNO
Investigators
Principal Investigator: Henk FJ Hendriks, PhD Hendriks HFJ
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00523861     History of Changes
Other Study ID Numbers: P6281, Alcohol Research 19
Study First Received: August 30, 2007
Last Updated: September 10, 2007
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by TNO:
Glucose
Insulin sensitivity
Glucose metabolism
Appetite
Satiety

Additional relevant MeSH terms:
Alcohol Drinking
Drinking Behavior
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 28, 2014