Moderate Alcohol Consumption, Glucose Metabolism and Gastric Emptying

Obese Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00523861
• Other study ID #: P6281
• Secondary ID: Alcohol Research
• Status: Completed
• Phase: N/A
• First received: August 30, 2007
• Last updated: September 10, 2007
• Start date: May 2005
• Est. completion date: June 2005

Study information

• Verified date: August 2007
• Source: TNO
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: June 2005
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Alcohol Drinking
• Lean
• Obese

Intervention

Dietary Supplement:
• Moderate alcohol consumption

Locations

Country	Name	City	State
Netherlands	TNO Quality of Life	Zeist	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
TNO

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary objective of this study is to investigate the effect of moderate daily alcohol consumption on hepatic glucose uptake and peripheral glucose storage		3 weeks
Secondary	Secondly, the effect of moderate alcohol consumption on gastric emptying and postprandial wellness will be studied.		3 weeks